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Position: Assitant Manager – QA – Third Party Manufacturing

Location: Chennai, Tamil Nadu, India

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 the closure of action plans.
  • Stability: Minimum one stability station analysis to be witnessed at the site annually along with a physical description. Stability data of each product for all stations to be reviewed for compliance.
  • The 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 the 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 months 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.
  • Technology transfer: Checklist of products for initiation of technology transfer of products to be verified for compliance. Process validation batches to be witnessed & reviewed for compliance with the 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 with FLQR procedure and release of the batch.

TPM Products at contract manufacturing sites:

  • Control Sample: Control sample of a minimum of three batches of each product to be reviewed for physical parameters once in a year.
  • Stability: One stability station analysis to be witnessed at the site annually if the number of products is up-to ten if more than 10 then \/N+1 products to be selected. Stability data of each product to be reviewed for validation batches and ongoing batches annually.
  • QMS, Investigation & GMP practices at contract manufacturing sites (TPM/TPK)
  • Onsite investigation of market complaints along with the site team for actual root causes analysis and monitoring of the effectiveness of the action plan along with the closure of the same in the defined timeline.
  • Quarterly trending of market complaints; required action to be initiated in consultation with site QA head for repeated and critical complaints.
  • Accountable for the effectiveness of Abbott SOPs and quality technical agreement at contract manufacturing sites. To escalate the concern timely to Abbott management.
  • Identification of training needs of weak areas based on day to day observation, investigations, audits, etc. and minimum one training to be imparted quarterly.
  • OOS, deviation, incident & change control of Abbott products to be reviewed and investigation to done comprehensively. Tracking and closure of identified CAPA to be done effectively.
  • Aseptic area technics, environment monitoring procedures with data, preventive maintenance procedures, calibration procedures, routine qualification of systems and self-inspection procedures to be reviewed for effectiveness & compliance as per frequency and procedure defined in SOP on monitoring of contract manufacturing site.
  • Compliance for pharmacopeia updates & implementation to be ensured for Abbott products in a timely manner.
  • Abbott audit & visit compliance reports to be monitored for closure in time with effective CAPA.
  • Responsible for coordination between Abbott quality management and site quality management.
  • To prepare the performance scorecards of TPM’s quarterly and ensure compliance with the action plans provided by the TPM’s falling in the red/yellow category by the end of the same quarter.

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