Accountable for the product quality performance at TPM (Third Party Manufacturer), to ensure compliance according to the related regulations and Abbott Global / Regional Policies.
Responsible for product quality performance through product and supplier Quality Risk Management of deviation / investigation, change management processes, Product Quality Reviews, CAPAs, Stability program and other quality related tools.
Maintain good relation and communication with TPM, suppliers and internal stakeholder during management of all quality activitiesManagement and communicate quality complaints with TPM / Suppliers to get proper investigation report.
Communicate quality and compliance expectations with TPMs / Suppliers and follow performance to assure compliance with cGMP and Abbott Global / Regional Policies and support for improvement quality system.
Reviewing and approving TPM quality documents like Batch Manufacturing records, packaging records, validation plans, validation reports, stability plans, and stability reports, PQRs, etc.
Reviewing and approving change controls, exceptions, deviations and CAPAâsParticipating on site quality activities to support TPM / Supplier for improving / solving the quality problems regarding product or site quality system.
Responsible for maintaining proper documentation system as per Global / Regional Abbott proceduresResponsible for maintaining TPM / Supplier Quality Technical Agreement","industry" : "Healthcare","title" : "Senior TPM-Suppliers QA AssociateDivision : EPD Established Pharma
Travel : Yes, 25 % of the Time
Medical Surveillance : No
Significant Work Activities : Not Applicable