On site review of batch records, process data and analytical compliance of LL, TPM product batches.
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 site.
Onsite investigation of market complaints & review along with site team for RCA, CAPA and effectiveness of CAPA along with closure of same in defined timeline.
Impart trainings and monitoring effectiveness at TPM site for compliance and to reduce market complaint due to human error or practices.
Onsite 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 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. 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.
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.
