Assistant Manager Qa (tpm) Job in Abbott Laboratories

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.

TPM Products at contract manufacturing sites:

• Control Sample: Control sample of minimum three batches of each product to be reviewed for physical parameters once in a year.
• Stability: One stability station analysis to be witnessed at site annually if number of products are 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 site team for actual root cause analysis and monitoring of effectiveness of action plan a long with closure of same in 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 effectiveness of Abbott SOPs and quality technical agreement at contract manufacturing sites. To esca late 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 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 score cards of TPM's quarterly and ensure the compliance to the action plans provided by the TPM's falling in red / yellow category by end of same quarter.