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 sitesLead 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 ChainOrganization in third party and LL manufacturing sites in applicable region.Promote Quality Management System as an important management tool with increasedvisibility across the business and guide the team for effective implementation at 3rd partycontractors.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 areaddressed as per Abbott policy in stipulated time at applicable TPM sites.Establish KPI’s and analyse the same periodically to improve the compliancemetrics 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 neededEnsure development needs are identified for direct reportsEnsure Quality budgets are maintained and managed for TPM QA organizationEnsure 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 theCAPA;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