www.stabicon.com Life Sciences Pvt Ltd Bangalore : Quality Control Manager

[ijt.kodi]

Company Name : Stabicon Life Sciences Pvt Ltd (stabicon)
Company Location : Bangalore
Designation : Quality Control Manager

http://www.stabicon.com/careers.php

Quality Control Manager
Skills Qualifications : M.Pharm (5 – 8yrs exp) or Ph.D (4 – 6yrs exp), with analytical chemistry background OR M. Sc (Chemistry / Analytical Chemistry), B. Pharm ( minimum 10yrs exp)Experience in industry a must. Should have thorough knowledge on Quality Control Testing of Raw Materials (APIs , Excipients), Various forms of Solid & Liquid Oral dosage forms and Injectables, etc…. Must have good technical knowledge and experience on HPLC, GC, UV-Vis, etc…ing and oral communication skills. Experience in facing regulatory audits desirable.
Responsibilities :
1. Handling about 15 – 20 analytical team and coordinating with about 7 member Analytical QA
2. Monitor analytical activities and experiments in support of the development, including method development, method validation, method transfer, compatibility studies and stability tests as per ICH, MHRA, USFDA, MCC, etc…guidelines.
3. Responsible for timely deliverable of laboratory activities related to Chemical, Instrumentation and microbiology testing
4. Provide oversight on environmental monitoring and microbiology during facility validation activities.
5. Develop the technical, GMP and leadership skills of QC personnel.
6. Ensure laboratory compliance.
7. Ensure quality control policies or procedures are appropriate. Establish and / or revise as necessary.
8. Ensure regulatory and customer inspections readiness; represent area and participate in audits.
9. Ensure compliant and timely testing of samples received at laboratory and stability samples.
10. Ensure Stability studies and reports are compliant and timely.
11. Evaluate analytical raw data and laboratory analysis.
12. Ensure quality control department and equipment is maintained and reliable.
13. Ensure necessary equipment qualification and validations are complete.
14. Ensure the necessary training within the department is carried out and modified according to need.
15. Monitor and control method performance.
16. Designate and monitor the storage conditions for materials and products.
17. Maintaining Laboratory in compliance with the requirement of cGMP & cGLP and WHO.
18. Preparation and Review of SOP, STP, GTP, Specifications, protocols, etc.
19. To ensure that organization policies and disciplines are implemented and maintained effectively.
20. To notify the management in case of OOS, OOT, Deviation, Change control and to fill the required documents.
21. Timely Investigation and closure of all such notifications with CAPA.
22. To update the system as and when required due to any change, revision in regulatory guideline, pharmacopeia, or any additional customer requirement.
23. Define roles, responsibilities, project scope, timelines and deliverable. Track progress of projects within agreed timelines.
24. Directs Work Instructions to analysts for the testing and analysis of Stability Develop and administer schedules, assign responsibilities within the group Document all laboratory work to meet regulatory standards and perform data Review.
25. Stability testing : Protocol design, Long - term stability test, Drug substance stability testing, Comparator stability testing, Formulation evaluation stability testing, data trending, Forced degradation studies, Photo stability, Temperature cycling.
26. Collect, analyze and interpret data, keep records of experiments including results and conclusions, recognize aberrant results and data trends, and provide plausible explanations including plans for follow up experiments to clarify findings.
27. Assign and perform training and development goals to the group.
28. Achieved deliverable and contributed to meet targets for each quarter.
29. Successfully initiated and executed stability studies with detail trending and investigation.
30. Designed experiments and delivered results, demonstrating awareness of customer demands and focus.
Reporting : Reports directly to management
Salary : Negotiable:

Contact us :
Stabicon Life Sciences Pvt Ltd
3BM-416,
3rd Block, HRBR Extension,
Bangalore-560 043,

[Guest]

CURRICULUM VITAE
Swarnalatha D M
E-mail : swarnadm AT gmail.com
Banglore
-----------------------------
Career Objective :
To associate with an organization which gives me a chance to improve my knowledge and enhance my skills in latest technologies and be a part of the team that works towards growth of the organization.
Strengths :
- Having good communication skills and eager to learn new technologies.
- Leadership qualities and motivating force to the team.
- Participating in group discussions and seminars.
Work Experience :
i) Worked as a “Chemist” in Quality Control Department of Apotex Research private ltd; from November 2010 to Jun 2012.
JOB RESPONSIBILITIES :
- Since my joining in the industry I have got well exposed in the following field of analysis by using modern instruments.
- Operating of different Analytical instruments
- Testing the Purity & Assays of as per guidelines by HPLC.
- Stability Studies .
- Method verification samples.
- Maintain the laboratory as per GLP.
- Handling different instruments like HPLC, UV, Dissolution Test Apparatus, Friabilater, Hardness tester, Disintegrater and KF autotitrater etc;
Other Responsibilities :
- Preparation of Standard Operating Procedures.
- Maintaining laboratory Records & Files.
- Control over documents.
- Following good GLP.
Instruments handled
Handling of the following Analytical Instruments :
- Instrument : HPLC
Make : Agilent, , Waters(Gradient), Schimadzu
Instrument :Dissolution appararus
Make :Electrolab(automated),Distek
Softwares : LC-Solutions, Autochrom, Empower2.
- Instrument : UV-VIS Spectrophotometer
Make : Shimadzu
Instrument :pHmeter,Analytical Balance ,Friability,DT and Hardness tester
Audit faced :MHRA twice.
Academic Profile :
- POST GRADUATION (M.Sc. Biotechnology) with 74% aggregate from Kuvempu university.
- PG diploma in Genetics, Kuvempu university Topper(distance education from kuvempu university).
- GRADUATION (B.Sc.in Botany Biotech and Chemistry) with 75% aggregate from SRNMNC COLLEGE (affiliated to Kuvempu university)
- Plant tissue culture certificate course affiliated to Kuvempu university
Declaration
I consider my self familiar with chemical analysis concepts, I am also confident of my ability to work in a team.
I hereby declare that the information furnished above is true to the best of my knowledge
Place : Banglore
Date : (Swarnalatha)

CURRICULAM VITAE
Ch.Naga siva
E-mail Id-chnagasiva AT gmail.com
Bangalore.
Career Objective :
To prove my capability and worthwhile using the best of my ability contributing for growth, prosperity and benefit of the organization.
Work Experience :
- Worked with HETERO Drugs in HYD as a Sr. Chemist in QC dept. since Sep 2010 to Sep 2012.
Educational Profile :
1 M.Sc. (Analytical Chemistry) from Andhra University (2007-2009) with 68 %.
2 B.Sc. (Chemistry) from Andhra University (2003-2006) with 67 %.
Instruments Handled :
1 HPLC Waters (Empower- 2487)
2 UV-Visible spectrophotometer (Analytikjena, shimadzu)
3 IR- Spectrometer
4 Digital Polari meter (Jasco P-2000).
5 K.F Autotitrators-Metrohm
6 Melting point. Job Responsibilities
1 Regular analysis of final/finished products.
2 Do chemical analyses like SOLUBILITY, LOD and BULK DENSITY, ASH.
3 Sampling of final/finished products
4 Preparation of volumetric solutions...
5 Collect all in process sampling and raw materials.
6 Maintaining laboratory records and files.
Software’s knowledge :
1 MS Office
Strengths
1 Ability to work as a Team member or individually.
2 Ability and determination to work for long hours.
3 Good in interpersonal, communicational and management skills.
Personal Profile :
Name : Ch.Naga siva
Date of Birth : 04-03-1986
Sex : Male.
Marital Status : Married.
Nationality : Indian.
Languages Known : English, Hindi and Telugu.
Permanent Address : West Godavari (dist)Andhra Pradesh
Declaration
I hereby declare that the information furnished above is true to the best of my knowledge.
Place :
Date : (Ch.Naga siva)

[Unregistered]

I completed my bpharm in this year itself. My percentage is 74. So, can I apply for the vacancies you have listed?