Watson Mumbai : Corporate Quality Operations

[mskavi]

Watson Mumbai : Executive - Corporate Quality Operations
Website: http://www.watson.com/

Keywords: Process Validations,Change Controls, Executive QA,

Designation: Executive - Corporate Quality Operations
Experience: 5 - 7 Years
Location: Mumbai
Education:
UG - B.Pharma - Pharmacy
PG - Any PG Course - Any Specialization,Post Graduation Not Required
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Production, Maintenance, Quality
Posted Date: 31 Jul

Job Description:

1)New Vendor Approvals
2)Conducting self inspection of Watson manufacturing sites
3)Handling of Change Controls /Deviations /Incidents /OOS
4)Knowledge of R&D QA
5)Equipment Qualifications / Process Validations / Analytical Method Validations

Desired Candidate Profile:

1)New Vendor Approvals
2)Conducting self inspection of Watson manufacturing sites
3)Handling of Change Controls /Deviations /Incidents /OOS
4)Knowledge of R&D QA
5)Equipment Qualifications / Process Validations / Analytical Method Validations

Company Profile:
Watson Pharmaceuticals is a leading specialty pharmaceutical company that uses innovative science and market insight to develop responsive products for a changing world. US based MNC. Having presence in India at Mumbai & Goa

Executive Name: Ms. Pearl Shenoy

Address:
Not Mentioned

Telephone: Not Mentioned

Keywords: Process Validations,Change Controls, Executive QA,

[Guest Poster]

D.SUDHEER KUMAR
Flat No:407
Kylas Kalyan Apts
Bhagya Nagar Colony
Near Sai Baba Temple
Hyderabad-72.
d_sudheer1 AT yahoo.com
Cell: 9849837876

CAREER OBJECTIVE
I would like to work and grow in an environment, where performance is rewarded with new responsibilities, and serve in a reputed growth oriented Industry in the field of Pharmaceutical, Development and Maintenance to power my career ahead.

EXPERIENCE SUMMARY: 9.0 years of Experience
- Presently working as a “Q.C(Stability)-Senior Executive” in M/s Aurobindo Pharma LIMITED Formulation unit from April 2005 to till date, which is a reputed Largest MNC Pharmaceutical Industry, based at Hyderabad, A.P. The company has received approvals for several facilities from leading regulatory agencies like USFDA and Health CANADA. The Company is marketing products globally.
- Worked as “Q.C SENIOR CHEMIST” in M/s Sarvotham Care Ltd, Chintal, Hyderabad (A.P.) from March 2001 to March 2005. It is a manufacturing unit of Health Care & Home care Products.
- Worked as “Q.C. CHEMIST” in M/s Caplin Point Laboratories Limited, Pondycherry, Jul ’1999 to March 2001.
- I am always welcome suggestion and advices from subordinates and Good Environment Creating with colleagues.

AUDIT SKILLS
- USFDA, EDQM and Health CANADA etc.

JOB RESPONSIBILITES

- Preparations of SOPs, STPs and Test data procedures.
- Preparation of ATD’S and Review.
- Preparation of Stability Protocols and review.
- Analytical data review and compilation.
- Rising of Change Control and deviations.
- Issuing of control copies of ATDs, SOPs, Protocols and other log books.
- Qualification (DQ, IQ, OQ, PQ) and Validation of Stability chambers and instruments (HPLC).
- Preparation of different Instrument Calibration schedule like HPLC, Balance, UV etc.
- Responsible for cGLP in Laboratory.
- Responsible for conducting of internal audits.
- Maintains proper documentation associated with the preparation and Review of Analytical specifications and Raw Data.
- Responsible for testing of raw materials, Intermediates and finished products.
- Monitoring of method transfer, in- process checking, sampling, monitoring of control samples and stability samples.
- Lead a group of Eight to Ten members team.
- Work planning according to Monthly & Master Schedule.
- Maintains of stability chambers (Charging, Withdrawal and Discarding of samples)
- Preparation Master Schedule and monthly schedule for stability samples.
- Investigation of OOS and OOT analysis.
- Analysis of Pharmaceuticals using HPLC, and wet chemistry.
- Reconstitution Studies by using HPLC and supported to FRAD.
- Working Standard Preparation and maintain record.
- Trouble shooting on HPLC problems.
- Work for customer complaints analysis. Completed the synthesis and delivered the products.
- Handling of Analytical Instruments-HPLC, UV-Visible spectrophotometer, K.F.Titrator, Dissolution Apparatus, and Disintegration Apparatus.

HANDLING OF INSTRUMENTS

- HPLC (High Pressure Liquid Chromatography), (Make: WATERS 2695 & SHIMADZU LC2010)-LC Solution,Class VP Softwares.
- UV-Visible Spectrophotometer (Make: SHIMADZU UV- 1700)
- Dissolution Apparatus (Electro Lab)
- Disintegration Apparatus (Electro Lab)
- FTIR (Make: Ferkin Elmer Spectrum One)
- Karl Fischer titrator (Make: Metrohm)

TRAINING PROGRAMS

TRAINING PROGRAM:

- Internal training for USFDA based Regulatory analysis and documentation
- Regulatory based audit preparation and Program on GMP and GLP conducted by Aurobindo pharma Ltd.
- Exposure to MS Office. (MS-Word, MS excels)


ACADEMIC PROFILE
Obtained M.Tech.( Bio- tech) from JNTU,Hyderabad.In the year of 2009.
Obtained B.Pharm , From DR.M.G.R. University, Chennai. In the year of March,1999.

PERSONAL PROFILE
Name : D.Sudheer Kumar
Father’s Name : D.Gangadhara Rao
Date of Birth : 20-07-1976
Languages Known : Telugu, English, Hindi and Tamil.
Marital Status : Married
Present Address : Flat No:407,Kylas KalyanApts,
Bhagya Nagar Colony
Near Sai Baba Temple
Hyderabad-72.

Strengths :
1. Good analytical and decision making ability
2. Superior motivational skills
3. Positive attitude having good leading skills.


I assure you that I can discharge my duties to the utmost satisfaction of my superiors.

Thanking you Sir/Madam

Date:
Place: Hyderabad (D.SUDHEER KUMAR)

[Guest]

Résumé
Private & Confidential
MUKESH SHAH
Associated with Pharmaceutical Industry since 1981...

PROFILE
Dedicated and resourceful Professional with product and service oriented experience of over three decades within the Pharmaceutical sector. Demonstrated record of achieving and surpassing personal and corporate objectives. People and task-oriented individual with an ability to build strong relationships; with both, internal and external clients. Reliable, detail-oriented, focused and results driven individual.
Tenure of service span through all aspects of Hard core Quality Assurance involved in manufacturing and controls of APIs and pharmaceutical dosage forms. Viz. Tablets, Capsules, Liquid Orals, Dry Syrups, Injections externals etc. A good background of Vendor Qualification and Assurance.
Hands on experience on state-of-the-art modern analytical instruments and data interpretation.
Desired Job Profile :
Lead organisational Quality function at Corporate level.
Guide and support Contract Manufacturing/third party outsourcing
Support Supplier (Vendor) Qualification /Assurance.

PROFILE
Dedicated and resourceful Professional with product and service oriented experience of over three decades within the Pharmaceutical sector. Demonstrated record of achieving and surpassing personal and corporate objectives. People and task-oriented individual with an ability to build strong relationships; with both, internal and external clients. Reliable, detail-oriented, focused and results driven individual.
Tenure of service span through all aspects of Hard core Quality Assurance involved in manufacturing and controls of APIs and pharmaceutical dosage forms. Viz. Tablets, Capsules, Liquid Orals, Dry Syrups, Injections externals etc. A good background of Vendor Qualification and Assurance.
Hands on experience on state-of-the-art modern analytical instruments and data interpretation.

PROFESSIONAL STRENGTHS
- Proficient with International regulatory requirements of CGMPs as per USFDA, MCC, MCA, TGA, etc. - Interpersonal & Communication Skills
- Client Relationship Management
- Problem-Solving & Creative Thinking - Analytical
- Training & Development - Presentation Skills - Team Work
- Time Management - Customer-Focus
- Computer Skills : All MS Office Applications including Internet & Email
EMPLOYMENT EXPERIENCE
PRIMAL HEALTHCARE LIMITED, Mumbai, India Aug 2006 – Till Date
Chief Manager – Corporate Quality Assurance
Actively supported in integrating Corporate QA functions.
- Corporate Training and Cross Plant Audit activity :
Actively participated and extended support to the Corporate QA Cell in various GMP training and Auditor’s training & refresher training. Coordinated Corporate Cross plant audit and Internal Quality Audit at Corporate QA.
- Due –Diligence & Contract Manufacturing :
Site evaluation for Gap analysis and support to follow up compliance. Further extended on going monitoring and support for formulation contract manufacturing sites as per scheduled audits and routine visits besides; for regulatory inspection/customer audit preparations.
- Customer Complaints Handling : Actively supported preparation of “Resolve”- software for handling Customer Complaints and MIS.
- Vendor Management :
Overall responsibility of Vendor Evaluation and Approval for all Intermediates, APIs, Excipients and Packaging components on domestic front. Extended support to Piramal UK site by evaluation and qualification of vendors in India, South East Asia and Europe. More than 250 sites evaluated as a part of the assignment.
o Vendor Development & support : Extended training and development support to prospective vendors for achieving USFDA certification and meeting organisational expectations.
o Vendor Performance monitoring and Review (VPMR) : Conducted Bi-annual exercise for reviewing vendor performance.
ACHIEVEMENTS :
Earned “Manathan Guru” excellence award as a part of Aldona Vendor development project during 2007.
IPCA LABORATRIES LIMITED, Mumbai, India Sept 1989 – July 2006
Senior Manager – Quality Assurance
- Vendor Assurance :
o Played a pioneering role in establishing Vendor Assurance Systems under the able guidance of Our Ex Vice President. (Dr. R. K. Mehra)
o It involved Evaluation and Approval of New Vendor(s) and on-going Vendor's Performance Rating. As a part of assignment, we audited more than 200 vendor’s manufacturing facilities.
o Coordinated the whole activity of vendor evaluation/Approval and vendor rating for all Drug Product Vendors, BPC Vendors and Packaging Vendors of Ipca and its' group companies.
- Training :
o Independently coordinated the training activities of Ipca and group companies, during the preparation for International Inspections of USFDA, MCA and ISO and overseas customer(s). I have conducted extensive training in GMP at all levels and I was actively involved in the preparation of the Corporate Training Manual. I was also a qualified "Trainer" for organizational TQM activities.
- Quality Audit.
o As qualified Auditor of the Corporate Audit Cell of Ipca, lead Corporate Audit team for Vendor Audits and Sub-Contract Manufacturing Audits. Internal Quality audit (self-inspection) and Failure Investigation audit were the other types of audits conducted as a part of the assignment.
o Actively participated in the International audits of USFDA, MHRA, MCC, TGA, WHO faced by Ipca group locations.
o Acted for both the roles of Auditor and Auditee as per the need of the situations.
- Customer Complaint :
o Review and overall co-ordination of quality complaint receipts, communication to concerned location, root cause evaluation, investigation reporting and final feedback to the complaint initiator.
- Validation :
o Played an active role in preparations of Validation Master Plan, Protocols for Equipment / System Qualification and conducting of Process Validation for Exon Mahad Astra Zeneca project.
- Documentation :
o Developed various specifications, SOPs, training modules for manufacturing and quality assurance.
o Acted as Management Representative and coordinated total activity of preparing Quality System documentation as per ISO 9000 viz. Quality Manual, Quality Procedures, SOPs, WIs, Training Modules etc.
ACHIEVEMENTS :
- As a Corporate Trainer coordinated and lead plant wide GMP training for Ipca, Ratlam, Athal and Kandla plant for USFDA and MHRA inspections.
- As a Corporate coordinator lead Exon Mahad plant through successful ISO 9000 and Astra Zeneca Customer Audit.
RANBAXY LABORATORIES LIMITED, Dewas, MP, India Aug 1988 – Aug 1989
Assistant Manager – Quality Assurance
Plant QA
- Gained a broad-based exposure to the In-process controls and Standard Operating Procedures of Formulation manufacturing and packing of operations to bring about plant-wide Quality Assurance.
Internal Quality Audits
- Conducted periodic Quality Audits of the various plant sections comprising of Warehouse, Manufacturing, Packing, and Quality Controls. Various formulations manufactured comprised of semi-synthetic penicillin, Cephalosporin and other drugs while the dosage forms comprised of dry syrups, tablets, capsules, and injections.
ACHIEVEMENTS :
- Targets achieved for reduction in re-processing rework and Customer Complaints
M.J. INSTITUTE OF RESEARCH, Baroda, Gujrat, India Jan 1986 – Aug 1988
Senior Scientist
- Develop new formulations and modify the existing ones. The laboratory formulation developments were carried out on "Erweka" series of instruments.
- Develop analytical specifications and methods for M.J. Pharmaceuticals.
- Training and development of co-research staff in the operations and handling of the instruments.
ACHIEVEMENTS :
- Developed new and modified existing formulations. Achieved a sizable cost reduction / earned an increased profit margin.
- Worked in close co-ordination with production plant activities and resolved a few online production problems.
- In the later phase of services, actively coordinated in the establishment of multidisciplinary research center having micro process control instruments like UV-Vis, IR spectrophotometers, GC, HPLC, Atomic Absorption, Spectro-photo fluorimeter etc.
SARABHAI RESEARCH CENTER, Baroda, India Mar 1982 – Sep. 1985
R&D Analyst
Formulation Development
- Performed, Pre-formulation and Formulation development. Conducted accelerated stability and forced degradation studies for a few antibiotics and Vitamin formulations.
- Developed, "In Vitro-In Vivo" correlation data for a few sustained release formulations using "Sartorious" absorption-dissolution simulator.
Analytical Development
- Prepared Guide Testing Procedures (GTPs), for the routine analysis of the Raw Materials, Intermediates, and Formulations by Chemical and Instrumental Methods of Analysis.
CHEM-MED-ANALYTICAL LABORATORIES, Mumbai, India Sept 1981 – Mar 1982
Trainee Analyst
- Perform analysis of Pharmaceutical raw materials and formulations by Spectro-photometry and Chromatographic methods of analysis
QUALIFICATIONS
UNIVERSITY OF MUMBAI, India 1981
- Masters of Science (Physical Chemistry) (Specialisation – Physical Methods in Chemical Analysis)
UNIVERSITY OF MUMBAI, India 1979
- Bachelor of Science (Hons) (Major : Chemistry & Physics)
FDA, Maharashtra, India 1995
- Certified Chemical and Instrument Analyst
INDUSTRIAL TRAINING - HICO INDUSTRIES, Mumbai, India 1981
- Training in State-of-Art Analytical techniques at R&D Centre

[Guest]

Ashish R Srivastava
E mail : ashishr_s05 AT rediffmail.com ;
ashishr_s07 AT rediffmail.com
Curriculum-Vitae
Quality Assurance – Documentation & Compliance Experience : Approx. 07Years

CURRICULUM VITAE
1. Objective
To work for an organization with strong belief and determination to achieve the desired goal with personal achievement.
2. Professional Background
Current Employer
Alkem Research Centre, Taloja, Navi Mumbai (M.S.) from 19th Nov.2010 as a Senior Research Scientist – Regulatory Affairs (Document & Audit Compliance).
It is a rapidly growing Pharmaceutical Company having WHO (local & Geneva), USFDA approval & MHRA Approval.
Previous Employer
a. Ipca laboratories Ltd., Ratlam, as a Jr. Officer(QA-IPQA & Documentation Activity)
b. Ranbaxy Laboratories Limited, Dewas (M.P.), as a Sr. Officer(QA - Documentation)
3. Work Experience
a. Ipca laboratories Ltd. Ratlam from Jul.2005 to Aug.2008
b. Ranbaxy Laboratories Limited, Dewas (M.P.) from Sep.2008 to Nov.2010
4. Current Job Profile
- Data Review {Batch Manufacturing and Packing Documents,Specifications,Validation Protocol & Report, Stability Data}for ANDA filing and other document compliance activity for EU, Canada, Australia& US Markets.
- Change Control, Deviation, Batch Manufacturing and Packing Documents review &Approval
- Familiar with e-CTD and worked in Module-3
- Document compliance for deficiency received from USFDA, Data compilation for Annual reports under supervision.
- Review of Technical/Commercial Agreements with the EU and Australia Customers
- Handling of Technology Transfer activity with the stakeholders (Plant & Customers)
- Actively Co-ordinating with stakeholders for Regulatory Audit Compliance.
- Co-ordinating with stakeholders/Various Departments for Documents availability on the stipulated time for regulatory filing
5. Previous Job Profile
Ipca Labs Ltd., Ratlam (M.P.)
- Involved in the IPQA checks & execution activity of Solid & Liquid Dosage Form Products according to SOP and cGMP practices at shop floor.
- Process validation (sampling, monitoring & Protocol Compilation).
- Handling of Change Control/Deviation & its closure.
- Auditing of Batch Manufacturing and Packing Documentsthoroughly at every stage during in process checks
- Master Manufacturing Document (MMD) Review and review of Batch Manufacturing & Packing Records
- Batch Manufacturing and Packing records Issuance; Controlling of SOP and relevant formats/documents
- Annual Product Review Compilation
- Documents review of Raw Material/Finished Product/Packing Material related specification against Pharmacopoeia and MMD
- Regulatory Follow-ups (Providing the documents/Finished Goods/Packaging Material Samples as per dossier/registration requirement of the respective countries).
- SCM Operation (Supply Chain Management) to ensure online documentation of RM/PM/FG materials
Ranbaxy Laboratories Limited Dewas (M.P.)
- Documentation Control (Change Control, SOP’s, PV Report)
- Handling of Change Control & Planned Deviation & its closure
- Annual Product Review Compilation
- Review of Technical/Commercial Agreements of the various Customers
- Training Record Maintenance
- Controlling of SOP and relevant formats/documents
6. Qualification
- B.Pharma from Rajiv Gandhi University of Health Sciences, Bangalore in year 2005 with 1st Division
- D. Pharmacy from Orissa State Board of Pharmacy, Bhubaneswar in Year 2000 with 1st Division

8. Declaration
I hereby declare that all the above information is true to the best of my knowledge.
Date :
Place :
(ASHISH RANJAN SRIVASTAVA)