Panacea Biotec is a leading research based Health Management Company. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.
We offer stimulating work environment & a career that spells growth. In tune with our plans, we require young, aggressive, dynamic, high performing and result oriented professional.
Designation : Senior Executive / Assistant Manager – Quality Assurance
Job Description :
1. Lead and/or support Quality / Compliance initiatives to improve / harmonize Quality Systems in R&D.
2. Assist R &D departments in the development of quality systems through implementation, training and periodic review of SOPs and guidelines.
3. Review & approve key technical documents of R&D (eg specifications/test methods of raw materials, in-process and finished products, stability protocol, analytical/bioanalytical method validation protocol and report, bioanalytical study reports, packaging documentation, equipment qualification and calibration related documents etc.)
4. Manage and review QA systems such as change control and planned/unplanned deviations, lab investigations, and CAPAs for R&D audit observations.
5. Ensure suitability of instruments/equipments for usage and maintain their calibration/maintenance records.
6. Conduct internal periodic compliance checks to assure the implementation of systems and follow up with corrective action, if required.
7. Update system documents for continuous improvement, as & when required.
8. Whet and approve protocol/report prior to agency submission, especially for experiments carried out as a part of query response
9. Support R&D and Product Supply and provide assistance in project / technology / method transfer to commercial QA/QC.
10. Participate in preparation of Quality Agreement with new 3rd party / contract labs as required by the development team.
11. Participate in development of GMP/GLP training program, on job documentation training for R&D personnel and provide on-going GMP/GLP training to the R&D associates.
12. Provide training to new recruits in relevant system documents and provide refresher training to existing employees.
13. Handle inspections from Regulatory Agencies and follow up on the appropriateness and completeness of corrective action plans until closure.
14. Coordination with concerned team for licensing activity related to R&D, products and import.
15. Preparation / Review of BOM
Experience : 5-9 years
Age : 29-35 Years
Industry Type : Pharmaceutical or Vaccine
Functional Area : Analytical
Education : MSc / MPharm
Compensation : As per industry norm
Department : Quality Assurance
Location : Mumbai Grand R&D