Website Abbott India Ltd
Post Name: HEAD TPM QA
ROLE AND RESPONSIBILITIES :
Responsible and Accountable for the oversight of Quality operations and GMP compliance across the West and South EPD TPM’s for, LL Systems & Contract Operations in India.
Effectively monitoring the rating of TPM/LL sites
Lead the implementation of quality strategy and plan in the above-mentioned sites including EQD policies implementation.
Implement Quality Projects at identified TPM’s from time to time.
Ensure quality compliance to regulatory w.r.t. labelling, stability studies and documentation across the 4 business divisions to deliver acceptable quality products coming from LL and TPM sites to consumers on sustainable basis.
Develop strategy on quality as per Abbott`s EPD requirements for the Supply Chain
Organization in third party and LL manufacturing sites in applicable region.
Promote Quality Management System as an important management tool with increased
visibility across the business and guide the team for effective implementation at 3rd party
contractors.
Establish robust quality management systems through the supply network and ensure compliance.
Create culture which imbibes quality as a way of working through identified trainings and
awareness programs for critical LL and TPM sites.
Establish and implement a process to ensure all consumer complaints/ queries are
addressed as per Abbott policy in stipulated time at applicable TPM sites.
Establish KPI’s and analyse the same periodically to improve the compliance
metrics through departmental reviews.
Periodic quality reviews with COQA team.
Monitoring of LL & TPM tech transfers, SAP related matters and KPMG audit compliance.
Deputise for Director TPM QA as per needed
Ensure development needs are identified for direct reports
Ensure Quality budgets are maintained and managed for TPM QA organization
Ensure the COMPETE project runs as expected, efficiency and cost saving ideas are identified,
managed and implemented
Participate in “Management Quality Reviews” and “Functional interface meetings”.
Ensure that the associated TPM’s are maintained in a state of Quality and compliance and the
CAPA;s arising out of the audits are closed on time.
QUALIFICATION :
M.Sc / M.Pharm with 15+ years of experience in Quality Assurance majority in Contract Manufacturing / TPM QA in an pharmaceutical company
