Walk-in Drive for Quality R&D 18th November in Bangalore.
Company: Apotex Research Pvt. Ltd.
Job Location: Bangalore
Experience: 3 - 7 yrs experienced.
Quality R&D :-
1. To be responsible for all activities in the Quality Assurance, including GxP (cGMP/cGLP) documentation and implementation of departmental quality systems.
2. To ensure the smooth general day-to-day functioning of the Quality Assurance.
3. To review various documents like Validation/stability protocols, Validation reports, Specifications, Method of analysis, Analytical reports etc. for the analytical support to Analytical Laboratory and Product Evaluation and Analytical Support Laboratory
4. Preparation, Review and updation of standard operating procedures.
5. Review of Qualification/Calibration documents of in-house and external calibration Laboratory instruments.
6. To monitor and co-ordination of Stability Management activities like set-up and withdrawal of Bio/pilot/Exhibit batches and other stability samples as per ICH guidelines.
7. Review and co-ordination Out of specification (OOS) investigation and reporting.
8. Issuance and Documentation for Method Validation related documents. Co-ordination with different laboratories for technology transfer related activities.
9. Review and verification of LIMS Data.
10. Co-ordination of Change controls, Deviations and quality incident reports
11. Preparation of regulatory audits and compliance for the same.
12. Coordination for periodic self-inspection for evaluation of the effectiveness of the quality systems.Interview Venue:
Apotex Research Private Limited,
Bommasandra Industrial Area,
Jigani Link Road, Bengaluru.
Time: 09:00 AM to 12:30 PM
Note: Experience in a Pharmaceutical manufacturing unit with exposure to Solid oral dosage forms (tablets and capsules preferred).
Please don't apply in case interviewed in the last 6 months.