Job Description

JOB DESCRIPTION:
Role and Responsibilities :

• Responsible and Accountable for the oversight of Quality operations and GMP compliance across the West and South EPD TPMs 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 TPMs 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 KPIs 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 TPMs 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
The base pay for this position is N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY: Operations Quality
DIVISION: EPD Established Pharma
LOCATION: India
Mumbai : BKC Building
ADDITIONAL LOCATIONS:
WORK SHIFT: Standard
TRAVEL: Not specified
MEDICAL SURVEILLANCE: Not Applicable
SIGNIFICANT WORK ACTIVITIES: Keyboard use (greater or equal to 50% of the workday)