Strides Arcolab Ltd. Bangalore : Pharma Validation / Production

[mskavi]

Strides Arcolab Ltd. Bengaluru/Bangalore : Executive / Senior Executive - Validation
Website: http://www.stridesarco.com

Designation: Executive / Senior Executive - Validation
Experience: 2 - 4 Years
Location: Bengaluru/Bangalore

Job Description:
1.Involve in the generation of User Requirement Specification, preparation of design, installtion,operational, performance protocol of equipment,utilities & facility IN ORDER TO validate its compliance to design, installation,operation and performance so as to meet the predefined quality attributes of the products.

2.Receive Validation Plan, check planing feasibility with respect to availability of utilities, equipment, materials, & test method as per protocol,guideline, customer requirements & seek appropriate approval IN ORDER TO provide accurate and timely support to validation planning for effective utilization of resources
3. To review the process & equipment in cordination with cross functional team IN ORDER TO identify the risk, review the adequacy of current control measures of each process steps and as a whole system as per Stides's guidelines and regualory requiremnts so as to intiate mitigation strategy

4.Involve in the preparation and checking of validation related protocols, compilation of raw datas, documentation, issuance of validation protocols and check the same for correctness and completeness IN ORDER TO timely completion & submission of compiled validation document and reports with proper indentification and traceability to plant.

Desired Candidate Profile:
1. Post graduate/Graduate in pharmacy/Science/Engineering. At least 2 + years of relevant experience in Pharma Production/QA/validation

2. Knowledge of validation of aspects involved in manufacturing activities in pharmaceutical industry; GMP and regulatory requirements

Company Profile:
At Strides, the truly global pharma company, each day is more exciting - you never know from which part of the world the challenge may come!

In just 16 years, we have become a Rs.750 Crore top 15 pharmaceutical company. Behind our extra-ordinary international strides lies the will to excel which is reflected in our Global vision of partnering with over 10 of the top 50 pharmaceutical majors worldwide.

Telephone: 08066580242

Keywords: Executive / Senior Executive - Validation, Quality Assurance

[panksjoshi]

Hallo I m new member ..........

[BASAVARAJ.HIREMATH]

I WANT A JOB ON STRIDE FIRM

[vikram67]

sir i want a job im B.pharma

[s.geetha]

Dear sir/madam

I want a job in QA deparment,my qualification B.Pharm & MS pharma

[arungcp]

sir,
I am arunkumar from governement college of pharmacy am looking to work in QC OR R&D if you have any openings in your compeny please infrom me sir,am graduate in pharmacy

[Guest Poster]

Dear sir,
i have done B pharma & looking for a job.

Farqualith Mehdi
Bangalore
9886705399

[priyapoojari7]

hello,
Wanted to make carrier in QA if given an opportunity.I have 2 yrs exp in QA.

[sumibio1982]

Respected Sir,
I am a Postgraduate in Biotechnolgy. Currently I am looking for an opening in Life Science with a specific focus on Biotechnology in its Practicality. I am keen on building a career in Biology keeping in mind the overall improvement in quality of life.
As a college topper in B Sc Zoology and a 1stclass holder in Biotechnology(3rd Position at college level), I have cleared the Biotechnology Ph D Entrance test 2007 from Mahathma Gandhi University Kottayam, Keala and SET 2007(state Eligibility Test) from Govt. of Kerala with ease.
I would be an asset to your esteemed company if absorbed as an employee or even as a trainee as I am an eager learner.
Looking forward to hearing from you,
Yours Sincerely,
Sumi Chacko

[Guest]

hi sir
i want join in your organization

[Guest]

i am 2 yr experianced person from validation injectable

[Anjali sarath]

I AM A FRESHER M.PHARMACY. I WANT TO WORK IN PHARMA PRODUCTION /QA IN STRIDES FIRM.

[Guest]

M. JYOSTNA
Email id : mangatijosh AT gmail.com
Objective
To seek the position in a reputed organization where I could put into practice my innovative creative skill for the mutual benefit both for organization and me so as to have a promising future.
Academic Profile
- Pursuing Master of Pharmacy in Pharmaceutics in SVU college of sciences, S.V University 76% .
- Bachelor of Pharmacy from Annamacharya college of Pharmacy, Affiliated to Jawaharlal Nehru Technological University with an aggregate of 67%.
- Intermediate from Sri chaithanya Junior College with 77.9%.
- S.S.C (10th class) from little angels high school, tirupathi, chittoor (dist) with 63%.
Technical Proficiency
Capable in handling
- Tablet compression machine,
- Colourimeter ,
- Dissolution apparatus.
.
Computer Exposure
- Platform : Windows XP.
- Software : Ms Office.
Extracurricular activities
.- Active participation in Green Pharma Exhibition held at college level (ANCP).
- Paper presentation in Pharmacy Week Celebrations at ANCP.
Strengths
- Interested in learning new skills.
- Ability to work well under extreme pressure.
- Easily adaptive to new environments.
- Dedication towards work.

[Guest]

Sathyanarayana J.
email : sathyaaj AT rediffmail.com
Objective
Seeking senior level assignments in QA/QC/R&D/Testing & Inspection /Documentation/ Compliance/lab operations with an organisation of repute in the Petrochemical & chemical Industries.
Professional Scenario
More than 23yrs of experience in Quality Management & assurance, Testing & Inspection, Lab
Operation as well as Compliance in the sector of Pharma, Food & Petrochemical. Working as Manager – QA/QC for Doctor Pack India Pvt. Ltd Bangalore Expertise in System Implementation in quality standards as per ISO 15368, ISO 14644 clean room stds. Possess a clear understanding of the technology, quality control techniques, joined at the initial stage fresh implementation of the QMS Good Laboratory Practice, Good Manufacturing Practice, Lab equipment setup, maintenance, Food safety, Vendor development on RM & PM, support to management for effective implementation of cGMP, HACCP,Global regulatory requirements and corporate policy, successful Audit compliance from the customer audit outcome, Additional knowledge – Microbiology control, Customer & Regulatory Audit handling, DMF filing, Excellent communication and relationship skills.
Core Competence
Quality Management
QA/QC
- handling various Quality measures such as ISO, USP standards by maintenance of appropriate requisite documentation/records.
- Analysing and releasing raw materials packaging materials,
Inprocess and finished products as per the pre-set quality parameters
- Preparation and maintenance of working standards as per requirements and its standardization schedule.
- Knowledge in standard method analytics like APHA, ASTM, IP & USP and its norms.
Testing & Inspection
- Testing and certification of raw materials, inprocess samples, gas samples waste water samples and utility samples.
- Method development and validation i.e rigorous testing of methods to ensure that they are precise, accurate,reproducible, fool-proof and specific to product, etc.
- Interpretation of data generated using sophisticated analytical instruments including Gas Chromatographs, HPLCs, AAS, UV/Vis Spectrophotometers etc.,
Audits
- Carried out Internal and external audit for the existing system and procedure for ensuring compliance with IP, USP, BP system
- Participating in external audits for the same with sister concerns and give clear reports.
- Conducting internal audit to ensure the perfect system.
Documentation and Control
- Maintaining documentation such as Laboratory notebooks, electronic data collection/storage, instrument logbooks, training records, etc.,
- Reviewing analytical documents SOP’s general test procedures protocols and their summary reports.
Lab Operations
- Procurement and maintenance of Laboratory analytical standards viz, reference standards in house standards, primary standards, and in house impurity standards.
- Responsible for calibration & performance verification of all the lab equipments as per the calibration\ schedule. Able to install any Lab equipments like GC, HPLC, Spectrophotometer, FTIR, Autotitrators, analysers etc.,
Training and Development
- Imparting training to front line staffs, pertaining to quality implementation and compliance.
- Preparing need based training module, reviewing and conducting training for quality control personnel on SOP’s.
- Conducting technical training and evaluation of quality control chemists.
Organisational Experience
Currently working with Doctor Pack India Pvt.Ltd Bangalore as QA/QC Manager from Dec.2010 to till date.
Joined at the initial stage of the organisation, established QMS, ISO 15368, ISO 14644 suitable for the packaging Industry. Implemented regulatory requirements for ISO, USFDA, cGMP. Validation of AHU, Lab Equipments, Process Measures, Vendor development, Recruitment and Training of New employees for various discipline. Preparation of DMF in process. Customer complaint and consultation handling, Effective compliance report and implementation as per the customer audit outcome.
Oct 2008 to Nov 2010 Bioplus Ltd, Sipcot, Phase II Hosur as Manager(QA/QC)
Being the Head of the Department reporting to VP (Technical) - responsible for Total quality management- Leading 18 member team of QA/QC Chemist and Executives –100% EOU, Instrument Control, (12HPLC’s and 6 GC’s one GC-MS, AAS ), GLP/GMP complaince, Method development on RM & FP. The facility succeeded regulatory audits - BRC, ISO, Star- K-Kosher, Halal, cGMP etc., Certified Internal auditor for cGMP,ISO, HACCP(by TUV).
Achievement : Successfully developed a new analytical method in GC for one of the product (carbohydrate) to investigate the impurity level. Submitted the validation report of the same to USP. Await for confirmation of the method. Will be added in the Monograph after USP team verification.
May 2006 to Aug 2008 Global Calcium Pvt. Ltd
Hosur, TN
Asst. Manager (QC)
Ensured QC checks in Five Plants of various products (All API’s), RM (65 Products) - Finished Product clearance and certification. Instrumental control (Calibration, IQ, OQ, PQ) handled 15 Chemist to enable work feasibility and work allotment. Being an internal auditor, done internal audits, SIP’s and fixing of NC’s. Conversant in Lab instrument operations, trouble shoot, maintenance, AMC management. Stability Chamber management, Vendor evaluation and development. Analytical method validation for few products in HPLC, AAS. Malvern. Exposure on Customer audits/regulatory audits – successfully carried out 40 audits.
April 1996 April 2005 Pepsico Inc. Riyadh
Saudi Arabia.
Supervisor (QA/QC)
Headed a six member team of Quality control – The facility been audited by external agencies like AiB, Regulatory bodies every six months.
Contribution :
1. Quality system implementation right from startup of the company.
2. Quality awareness created at the front line level workers/staffs.
3. Packaging quality monitoring every hour with immediate corrective actions.
4. Successful audit results from 1998 till 2005.
5. Reporting Key Performance Information to Central Quality Department UK.
6. Trouble shoot of Instruments like GC, FTIR etc.,
7. New design development on Packing Materials.
8. In Market performance evaluation Vs Competitor
9. Conducting Quality orientation program.
10. Handling of enforcement Officers and Consumer complaints.
11. Plant equipments capability study - as per the Central R&D recommendations
12. Monthly Performance review on Supplier - Raw material & Packing material.
13. Passed AiB audit with excellent score of 790 out 1000. (for a Non-cGMP plant). The facility been audited by AiB twice a year.
August 1994 - April 1996 Arechema Peroxides India Ltd Chennai
Junior Officer QA/QC
Senior team member of the quality. Individual shift responsibility on quality for all downstream, raw material, Finished goods, Utility and Packaging material etc.,
Contribution
1. Zero incident report through out the service while handling hazardous chemicals like Organic peroxides, Oleum etc.
2. Synthesized analar grade solvents using distillation process from GPR grade at critical events. (cost control).
3. Timely report on QA Activities – Received bonus increment.
4. Trouble free operation of instruments GC, HPLC, Spectrophotometer.
September 1993 – August 1994 SM Dyechem Ltd, Pune, India
Chemist
Worked in shifts. Responsible for instrumental analyses of Inprocess, Finished good, Raw material using sophisticated instruments like GC, HPLC, and Spectrophotometer.
October1991 – September 1993 Ushta Te Tech Ind. Ltd Chennai.
Sr. Chemist
Role : As Team Leader Constructed Lab with suitable equipments for the Starch Process line and Instruments for Dextrose derivative analyses. Analytical Method development for starch derivative analyses in Wet chemistry and Intrumental analyses. Commissioned instrument HPLC, UV-Vis Spectrophotometer.
Achievements : Recommended a new process to the Management to reduce the process cost & time and Improved Quality - Well competitive in the Market.
April 1990 – October 1991 Amaravathi Chemicals Ltd Pondicherry
Sr. Chemist
Senior member of the quality team, responsible for Finished product assurance using HPLC, and wet chemistry.
October 1988 – March 1990 Asian Paints Ltd Chennai
Lab Chemist
Job Profile : Shift quality Control activities. Wet chem analysis, Instrumental analyses. Finished product clearance. RM Inspection and Acceptance. Knowledge in ASTM test procedures.
Achievements : Achieved best Analytical skill in Instrumental methods of Analysis.
Acadamic credentials
Bachelor of Science from Madras University specialized in Chemistry in 1988.
Master of Science (Chemistry) from Annamalai university (2007)

[Guest]

As am graduate and have experienced in Pharma field have knowledge on analysis of Raw material and Finished products.I have handled all the instruments related to my analysis and am expecting a good opportunity from your esteemed concern. now am employed in M/S.Adcock Ingram Ltd., Bangalore.

[Guest]

Hello.
I need job in strides. please help me.

[anupcoolguey@rediffmail.com]

Dear Sir/Madam,

I would like join in your esteemed organisation

I have 2 year experience in Export/Import & Logistics
if any opportunity for my profile
Please Let me know

Thanks & Regards
Sangamesh

[Guest]

I want to join your organisation

[Guest]

Dear Sir,
As a quality conscious personality with almost 9 years of experience in pharmaceutical Quality Control and Assurance, I think I can contribute effectively to your organization.
Presently I’m working for Teva API India Limited as Asst. Manager – Quality Control.
I have experience in Preparing and maintaining Quality System. Analysis of Raw Material, Finished products, Analytical instrument Validation, Customer and regulatory Audits and handling of various analytical instruments, GLP Compliance in Quality Control etc.
Hope I can get the opportunity to meet you during the interview.
Sincerely,
(Vivek Vashistha)
Career Objective
To associate myself with an organization that provides me an opportunity to show my skills and ability, improve my knowledge and to be a part of the team that works dynamically towards the growth of the organization.
Experience :
From : 16th January 2012 to till date – Teva API India Limited. J.P Nagar, Gajroula, Moradabad, India.
Position : Asst. Manager Quality Control.
From : 09th August 2008 to 07th January 2012 – Nectar Lifesciences limited. Unit-II Village Saidpura, Derabassi, Punjab, India.
Position : Asst. Manager Quality Control.
From : 22nd January 2008 to 09th August 2008 – Otsuka Chemical India limited.
(Japanese Group) Keswana Rajput, Baharor, Rajasthan, India.
Position : Executive Quality Assurance/Quality Control.
From : April 2004 to 13th January 2008 – Ranbaxy Laboratories Limited, Toansa. Position: Quality Control Supervisor.
From : 20th October 2003 to 15th march 2004 in Windlas Biotec Limited Dehradun.
Position : Quality Control Chemist.
Job responsibilities :
Quality Control :
- Procurement and maintenance of product reference standards. Planning & qualification of working standards for routine use.
- Calibration, Maintenance, Breakdown and Qualification of laboratory instruments.
- Clint Server Management / implementing / Maintaining Empower policies
- Maintaining AMC’s & Preparation/execution of PM Programs for instruments.
- Archival, Retrieval and Restoration of analytical data from computer system associated with Quality Control Instruments.
- Preparation and implementation of OS, AS, User maintenance, Backup/Archival Guidelines for all instruments being used in Quality Control as per 21CFR Part11.
- Creation, maintenance and control over user accounts and their access on different instruments.
- Responsible for Preparation, review and SOP compliance through out Quality Control.
- Failure Investigation / Out of specification investigation Stage-1.
- Procurement, issuance, suitability and withdrawal record of analytical columns.
- Procurement of spares for all analytical instruments. In Quality Control.
- Analytical Data Review (Finished Product Records, Qualification Protocols, Instrument calibration and usage Records, Daily and Monthly Backup of Instrument).
- Computer validation program in association with external agency named epitome technology for laboratory.
- Exposure of SAP, BAAN and DMS Software in Quality Module.
- Testing of Dosage forms, API, Raw materials, Intermediates and In-Process Samples.
- GMP/GLP compliance in the respective areas, of Quality Control Department.
- Protocol preparation, execution and summing up validation studies in Quality Control like Temperature mapping of refrigerators, chemical storage room, excel sheet validation computer validation etc.
- Responsible to support external audit in quality control and to prepare and comply the CAPA for the observations if any.
Quality Assurance
- Preparation of SOP’s SOCP’s and general Working Instructions.
- Handling Change control, periodic and audit based revision and new initiation for SOP.
- Ensuring the documentation as per cGMP requirement.
- Handling of Planned and Unplanned deviation in QC.
- Investigation of OOS (Primary investigation).
- Planning and execution of Market complaints and their closer. (QC Part)
- Internal, External and Customer Audits to meet cGMP.
- Imparting training to laboratory personnel’s.
Analytical Skills
- HPLC (Waters 2695 and e2695 With Millennium 2000, Empower and Empower 2)
(Shimadzu 2010 with LC Solutions 1.24, Lab Solution 5.30)
(Agilent 1200 Series with Empower & Aquity Water & Agilent FLC H-Class)
- UV Spectrophotometer (UV 3310 Hitachi)
(Shimadzu 1700 and 2450 with UV Probe)
- Atomic Absorption Spectroscopy. ( Perkin Almer 3100)
- Gas Chromatography. (Perkin Almier Terbomatrix and Total Chrom)
(Shimadzu 2010 with GC solution)
(Agilent Technology 6890 with Chemstation and Chemstore)
- Particle Sizer Malvern with Siroccos and Mastersizer 2000 (Dry and Wet dispersion system) (Version 5.70)
- NIR Spectrophotometer (Foss).
- FTIR – (Perkin Elmer Spectrum One)
(Shimadzu 8400S with IR Solutions)
(Shimadzu IR Prestige with IR Solution)
- Polarimeter (Autopol and Rudolph)
- HPTLC – CAMAG
- Auto Titrator – Metrohm, Mettler and Orion.
- DR & DT Apparatus.
- Flame Photometer, TOC etc
Academic Qualification
- Post Graduation Specilization in organic Chemistry
- Graduation Specilization in Industrial Chemistry
Research Experience
- One moth project work on manufacturing of tablets and Syrups.
- One month project work on manufacturing of large volume parental.
Audit Faced
- Successful completion of US-FDA for 7 products in Ranbaxy (December 2007), MHRA, GMP, WHO renewal, EUG and various Customer Audits.
- Successful completion of K-FDA, USFDA for cefuroxime Axetil in Neclife (June 2010 and 6-9th June 2011) Hungry EUG and various Customers Audit.

[Guest]

Good morning to you. I am new and I want to join stride company.

[Guest]

sir i am submitting my cv. so kindly reply

[Guest]

sir i want job in warehouse department

[Guest]

I would like to share my experience with Stride Acrolabs. I am graduate diploma in packaging Technology from IIP with eight years experience.

[Guest]

I am m.pharma(ceutics) 2nd year student from tamilnadu. I want a internship training in strides.pls give me chance sr, by sahul hameed

[Guest]

sir,
I am sanjay kumar from VIT University completed Msc pharmaceutical chemistry looking to work in QC OR R&D if you have any openings in your company please inform me sir,am post graduate in pharmaceutical chemistry.

thanking you
sanjay sharma

[Guest]

I have completed B.Pharmacy from rajiv gandhi university of health science Bangalore and am looking to make a future in R&D. So please inform me.

[Guest]

hi sir iam A.veerabhadrappa iam working in remidex pharma pvt ltd 2years 9months competed iam looking for executive IPQA IN YOUR COMPANY