Ensure product Compliance & Regulatory compliance of Abbott products at TPM sites.
Review of sites compliance through periodic visits, prepare the report and ensure the compliance.
Review and approval of TPM sites QMS elements (Change controls, incidents, Deviations, OOS, etc..) related to Abbott products and monitoring of action plan for effective closure at sites
Ensuring the Compliance for pharmacopeia updates for Abbott products at TPM sites.
Investigation of market complaints, significant quality events & review along with site team for RCA, CAPA and effectiveness of CAPA along with closure of same in defined timelines.
Core Job Responsibilities :
Site monitoring, on-site of review of batch records, process data and analytical compliance of LL, TPM, TPK product batches of designated sites.
Review products manufacturing process, line clearance, in-process checks and AQL practices to cross verify at process stages in compliance to approved procedures.
Onsite witness of analysis of finished product, raw material etc. for Abbott products to ensure compliance to approved specifications.
Monitoring of GLP procedures for analytical & data integrity compliance at TPM sites.
Investigation of market complaints, significant quality events & review along with site team for RCA, CAPA and effectiveness of CAPA along with closure of same in defined timeline.
Assess risk regarding significant quality events such as Site compliance issues, site Audit outcome, complaints etc.,
Impart trainings and monitoring effectiveness at TPM site for compliance and to reduce market complaint / significant quality events due to human error or practices.
Review & evaluation of QMS documents (Change control, deviation & incident etc.) related to Abbott products and monitoring of action plan for effective closure at sites.
Onsite witness of stability station analysis & review of data for Abbott products to ensure compliance to the stability program for all Abbott products at the site.
Monitoring for effective compliance of Abbott SOPs, policies and quality technical agreement at sites.
Review and ensuring the Compliance for pharmacopeia updates for Abbott products at TPM sites.
APQR : Review of APQR of Abbott LL, TPM & TPK products from sites.
Aseptic area techniques, 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 sites SOP. Ensure execution of media fill activities, review reports for applicable injectable sites.
Technology transfer : Check list of products for initiation of technology transfer of products to verify for compliance. Process validation batches to be witness & reviewed for compliance with approved protocol (process validation, hold time study & stability study).
Review of documents and samples of new product/existing product for FLQR compliance at site.
Monitoring of Abbott audit & visit compliance reports for closure in time with effective CAPA at site.
Execute the responsibilities as per TPM site monitoring procedure and ensure TPM sites compliance.
Review of control samples on a periodic basis as defined in the procedure
Review & support in Abbott projects running at assigned location /TPMs sites.
Review of Abbott TPMs product related operations, documents & ensure compliance at Abbott TPMs in respective zones /locations.
Review of sites compliance through periodic visits, prepare the report and ensure the compliance.
