Manager - Product Quality

Position Title:

Manager- Quality Assurance (P1)

Location:

India

Region:

India

Reports to:

Sr. Manager- Quality Assurance

Scope of Position:

Managing Quality Assurance of the Lilly pharmaceuticals in Lilly India Affiliate and Nepal

Objective:

• Act as Product Quality Representative (PQR) for India affiliate.
• Act as Alliance Quality Manager (AQM) for any business deal (e.g. Distribution and Promotion, Divestiture etc.) implemented within India affiliate.
• Act as Recall Coordinator back up for India affiliate
• Act as RCP back up for India affiliate
• Assist the Quality Management and the Local Management in meeting Lilly global policies and local quality procedures requirements that apply to the Marketing Affiliate.
• Ensure compliance with Good Manufacturing Practices (cGMP), Good Storage Practices (GSP), Good Distribution Practice (GDP) and others that apply to the operations of the local Affiliate, as well as compliance with applicable local regulations.
• Responsible for properly handle Corporate Quality audits, inspections of local regulatory agency program and execute the annual Quality self-inspections.

Manager-Product Quality is responsible for:

Assisting the Sr. Manager- Quality Assurance, Associate Director- Quality Assurance and Global Quality Leader in implementing the Product Quality Operational Manual for Marketing Affiliates (CQP-181-1) and ensuring meeting quality expectations of local authorities and marketing authorization.

Assisting the Affiliate management and Associate Director- Quality Assurance-IBU Business Deal in business deal initiation and implementation within India affiliate

Report to the Associate Director- Quality Assurance any issue or failure of the local quality and escalate to the Affiliate Management and Global Quality Leader in a timely manner when applicable.

Prepare Notification to Management as applicable after consulting the Sr. Manager- Quality Assurance and Associate Director- Quality Assurance. Assist Sr. Manager- Quality Assurance and Associate Director- Quality Assurance in preparation of quarterly quality metrics.

Determine urgently the impact of quality issues or failures on products, with special attention to those that may impact the safety of patients or produce a recall. Immediately notify the Associate Director- Quality Assurance for subsequent elevation to the Global Quality Leader and Local Management.

Support Sr. Manager-QA in developing the annual quality plan and submit it for review and approval as required by CQP-181-1.

Inspect and release batches of finished product for sale according to local standard operation procedure ensuring they meet all quality specifications and local regulations.

Ensure oversight of contract laboratory and escalate immediately any issue to Marketing Affiliate Analytical QA team, Sr. Manager- Quality Assurance and Associate Director- Quality Assurance.

Support Sr. Manager- Quality Assurance in collaboration with Lilly Compendial Expert to address any query or issue related to India Pharmacopeia or National Institute of Biologics Support Sr. Manager- Quality Assurance in collaboration with Lilly Supply Chain to understand importation regulations and activities and visit Mumbai Port ADC as applicable

Ensure that any deviation occurred is properly reported, investigated, and closed in accordance with standard operating procedure. Must ensure that the corresponding plan of corrective and preventive actions, involving relevant areas is established and completed on time. Any situation involving a deviation, release the batch of product for sale, only when the deviation report and their respective investigation indicated that the product meets the required quality specifications.

Ensure that change controls are raised timely and documented as per the standard operating procedure.

Ensure data integrity according to ALCOA+ principles and Good Documentation Practice.

Manage product complaints as per CQP-130-1 and local standard operating procedure as a Responsible Complaint Person back-up. Support primary Responsible Complaint Person in product complaints management in time of heavy workload.

Perform initial Quality Assessment to any new external party and periodic reassessments (between GQAAC audits) of the existing external parties that perform any GMP/GDP operation that could potentially impact product quality of Lilly products. Accompany and assist GQAAC auditor in warehouse assessments.

Prepare Quality Agreement to be signed between the external party and local affiliate; coordinate the process of signatures as well as the periodic review of the agreement as provided in the corresponding global standards. Monitor compliance with the external party on their standard operating procedures and Quality Agreement when applicable.

Report any deviations to the procedures. Qualify shipment containers and perform temperature mapping as required for CRT and Refrigerated products.

Conduct annual self-inspection.

Coordinate (ordinary or extraordinary) audits or visits, undertaking local regulatory agencies relating to GMP/GDP issues or quality management.

Notify Sr. Manager- Quality Assurance and Associate Director- Quality Assurance as soon as possible about the visit. Similarly, communicate the results of the inspection, with emphasis on cases investigated that has been conducted on samples or products, or has generated an observation or any situation that may represent a potential risk to the company.

Support Sr. Manager- Quality Assurance in responding to global quality audit report, after revision of the Associate Director-Quality Assurance.

Monitor and ensure timely Affiliate implement local action plans relating to GMP/GDP issues or quality management of the affiliate. Agree on Regulatory Agency or Global Quality Audit inspection responses with Sr. Manager- Quality Assurance and Associate Director-Quality Assurance.

Report immediately to the Sr. Manager- Quality Assurance and Associate Director-Quality Assurance suspected theft, tampering or other situations that could jeopardize product quality.

Ensure that local customization is performed following the guidelines established by the quality area and according to global policies and standard operating procedures that apply locally. Ensure any new customization activity is implemented after change control approval. Any GMP customization requires global Quality approval.

Review the returned products, ensure that any potential quality issue or failure that could have originated the return will be reported appropriately and coordinate if new provision applies to these products (including medical samples). In situations of product Recall or withdrawal of marketed Lilly products, Product quality representative takes the role of Recall Coordinator back up for the affiliate level and follows local standard operation procedure and CQP-131-1.

Evaluate and approve promotional materials or websites/E-channels that have potential impact on the Patient Safety and / or product quality.

Responsible for appropriate review and approval of quality documentation relating to GMP/GDP operations of local Affiliate. Conduct the training of Affiliate personnel including Country Manager and Sales Reps on GMP/GDP standards (e.g. special handling condition, PC management, free medical samples handling etc.) that apply to the Marketing Affiliate.

Support training programs to external parties in areas such as cold chain management and handling of returns, among others, as needed. Appointed as a responsible for controlled drugs and Lilly-designated Special Security Substance compliance by the affiliate general manager. Ensure readiness for new product launches Document product quality impact in case of product license withdrawal Report product shortages as applicable Support Sr. Manager- Quality Assurance in cooperating with Regulatory Affairs for new product launch and MoH/Regulatory agency communication.

a. Support local registration testing work arrange and technical review.

b. Arrange the MoH sampling/testing work through communication with regulatory/SCM team.

Support Sr. Manager- Quality Assurance in oversight of contract laboratory per CQP-181-3 Quality Oversight of Affiliate Managed Laboratories Performing Secondary Testing based in India to support tender institution business. Report to the local agency any quality defect detected in other country communicated to the Affiliate by the Affiliate Global Quality Leader when required by the local regulation. Operate on behalf of the MAH concerning GMP and GDP responsibilities.

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