- 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.
Role:Quality Manager / Supervisor
Industry Type:Medical Devices & Equipment
Department:Quality Assurance
Employment Type:Full Time, Permanent
Role Category:Business Process Quality
Education
UG:Any Graduate
PG:MS/M.Sc(Science) in Any Specialization, M.Pharma in Pharmacy