REFERENCE
Srinivasulu Tirumalasetty
Global pharma News
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Wednesday 16 November 2016
APOTEX WALK IN ON 18/11/16 @ BANGLORE
REFERENCE
Srinivasulu Tirumalasetty
Global pharma News
EXPERIENCE : 3 - 7 yrs
Apotex Research Private Limited (ARPL) based at Bangalore is engaged in in the development, bio-clinical evaluation, manufacturing, and distribution of safe and efficacious generic pharmaceutical formulations for the global market.
Inviting applications for the following position:
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.
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, Bengaluru, Plot 1&2, Bommasandra Industrial Area, Jigani Link Road.
Time: 09:00 AM to 12:30 PM
Job Location: Bangalore
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.
Salary will be not be a concern for desired candidate.
Required Documents: Candidates are requested to carry 2 copies of resume, passport size photograph, pay slips, educational certificates, salary annexure and previous experience certificates.
Education-
Company Profile:
CIPLA INDORE PLANT WALK IN ON 20/11/16 @ SIKKIM
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