Assistant Manager QA (TPM) - Abbott - Chennai

Job description

JOB DESCRIPTION:

TPM Products at contract manufacturing sites:

Control Sample: Control sample of each product to be reviewed for physical parameters twice in a year and timely escalate the product issues and track for closure of action plans.
Stability: Minimum one stability station analysis to be witnessed at site annually along with physical description. Stability data of each product for all stations to be reviewed for compliance.
Product manufacturing process of validation batches to be witnessed with cross verification of in-process checks and observations to be done for any stage in compliance to approved procedures for validation batches or minimum one batch in a month.
Finished product analysis for critical chemical (dissolution, RS & Assay) and physical quality attributes to be witnessed monthly one batch / as per plan for analytical compliance & GLP requirements at site.
Water & environment trend, MLT procedure & data of product / material analysis to be witnessed and trends to be reviewed quarterly or as per site schedule.
Raw materials & primary packing material of products to be reviewed with approved specification and pharmacopeial compliance once in six month for all products & ensure compliance if any necessary changes required to be done.
APQR: Review of trends of critical quality attributes for any significant shift and ensure implementation of recommendations to improve the trend for next year.
Techno logy transfer: Check list of products for initiation of techno logy transfer of products to be verified for compliance. Process validation batches to be witnessed & reviewed for compliance to approved protocol (process validation, hold time study & stability study). Deviation to be addressed for process changes approval.
FLQR: Review of documents and samples to be done for compliance to FLQR procedure and release of batch.

Minimum Education

B.Sc / M.Sc /B.Pharm / M.Pharm

Minimum Experience / Training Required :

At least 10 – 15 years of relevant experience in quality assurance function either at internal sites / third party manufacturers.

JOB FAMILY:

Operations Quality

DIVISION:

EPD Established Pharma

LOCATION:

India > Chennai : 147 Greams Road

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Offers “Abbott”