A holistic objective of dispensing health through a portfolio of injectable products across various therapeutic segments and delivery systems, has helped us expand to seven manufacturing facilities in India, with a capacity of approximately 750 million units. These include four facilities with 22 production lines for finished formulations and three Active Pharmaceutical Ingredient (API) facilities. Our products are produced at world-class manufacturing facilities and conform to global compliance, regulatory and quality specifications.
Vacancy Details
- Department: QMS
- Division: API
- Experience: 03-06 years
- Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm
- Job Location: Visakhapatnam
QMS Activities:
- Check for adherence to standard operating procedures in all departments.
- To check all the departments, which contribute to production of APIs for any deviation from GMP.
- To review the product manufacturing records, testing records and quality of release batches before the dispatch.
- Monitoring and coordinating the raw material dispensing activities.
- Archiving of documents and maintenance of record rooms.
- Ensure the implementation of Good Laboratory practices and good manufacturing practices.
- To review and maintain vendor documents and coordinate with head QA during vendor qualification.
- Preparation and review of SOPs.
- Preparation of the annual quality review reports of products
- Responsible for handling of change controls and to ensure the implementation of changes.
- Implementation of corrective action and preventive actions and periodical review.
- Preparation and review of quality risk assessments.
- Responsible for sterile IPQA activities. But not limited to:
i)Providing line clearance at various stages of operations i.e., (Dispensing, Compounding, Packing, etc.)
ii) Monitoring environmental conditions (Temperature, Relative Humidity, Differential Pressure, Particle Count, etc.)
iii) Filling of BPCR operations being performed in sterile area.
v) Review of equipment log book and cleaning records.
vi) Review of autoclave cycle report and EMS reports.
vii) Monitoring of in process and API sampling operations - Preparation of product labels
- Issuance of formats, Log books and documents to user departments.
- Responsible to preform GMP self-inspection as per schedule.
- To undertake any other job as assigned by the Head of Department QA