Job Description

JOB DESCRIPTION:Experience:
1. Knowledge of Contract Manufacturing Operations (CMO) process for the Pharmaceuticals.
2. Knowledge of current regulatory requirements such as Schedule M, Eu GMP, USFDA, ICH etc.
3. Rich experience in regulatory audits such as USFDA, EU GMP, TGA, PICs etc.
4. Minimum 10 years of experience in pharmaceutical industry.
5. Exposure in Quality control Lab., Validation, IPQA, QMS, complaints handling, self-inspection, vendor qualification, Technology Transfer, Contract Manufacturing Operations etc.Job responsibility:
1. Accountable for effectiveness of Abbott SOPs and quality technical agreement at contract manufacturing sites.
2. Accountable for compliance of Abbott audit & visit reports at respective TPM site.
3. To prepare the performance score cards of TPMs and ensure the compliance to the action plans.
4. Onsite investigation of market complaints and trending.
5. OOS, deviation, incident & change control of products to be reviewed and investigation to done comprehensively.
6. Compliance for pharmacopeia updates & implementation to be ensured for products within stipulated time frame.
7. Product manufacturing process to be witnessed with cross verification of in-process checks time to time to ensure the compliance with respect to approved procedures.
8. Finished product analysis for critical chemical (dissolution, RS & Assay) and physical quality attributes to be witnessed as per schedule.
9. Products manufacturing process, line clearance, in-process checks and AQL procedures to be cross verify at process stages in compliance to approved procedures during visit at TPM site.
10. Compliance of technology transfer of products as per organization requirements.
11. Process validation batches to be witnessed & reviewed for compliance to approved protocol (process validation, hold time study & stability study).
12. Ensure stability schedules are maintained at site and track the analysis. Stability data of each product to be reviewed for validation batches and ongoing batches as per schedule.
13. Review of documents and samples to be done for compliance to FLQR procedure and release of batch.
14. Control sample of each product to be reviewed for physical parameters as per defined frequency and timely escalate the product issues and track for closure of action plans.
15. Raw materials & primary packing materials of products to be reviewed with approved specification and pharmacopeial compliance on timely basis for all products & ensure compliance, if any necessary changes required to be done.
16. Ensure the timely preparation of APQR of products at site and review of trends of critical quality attributes for any significant shift. Ensure the implementation of recommendations for the any improvement in trend of quality attributes.
17. Ensure the schedule for calibration, validation / qualification, and preventive maintenance of equipment, apparatus, instruments, and systems etc. to be maintained at site. Track the implementation of the schedule and compliance of activities as per procedure.
18. Need-based training identification to be carried out at contract manufacturing site, based on day-to-day observation, investigations, audits etc.
19. TPM site visits and report preparation as per organization procedure.
20. Responsible for co-ordination between Abbott quality management and site quality management.The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations QualityDIVISION: EPD Established PharmaLOCATION: India
Sikkim : RemoteADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Yes, 75 % of the TimeMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott