Global TPM/Supplier- Product QA Manager

2 weeks ago

mumbai, India Abbott Full time

A. DEPARTMENT FUNCTION/OBJECTIVE

To manage the quality related activities at a number of Third Party Manufacturer’s (TPM’s) and Suppliers ensuring effective Quality and Compliance oversight to marketed global/ multiregional products for the Established Pharmaceuticals Division of Abbott, to ensure safe, efficacious and quality product can be supplied in accordance to regulatory and business requirements.

B. PRIMARY FUNCTION:

The Product QA Manager is responsible for providing QA general support for assigned TPM’s and Suppliers and associated quality systems to ensure that safe , efficacious and quality product can be supplied to Abbott to meet cGMP and other applicable regulatory standards and the appropriate market requirements.

C. MAJOR DUTIES AND RESPONSIBILITIES: 

Manage TPM’s and Suppliers as assigned from a Quality perspective. Provide support of global quality and compliance strategy for assigned commercialized products with global/multiregional scope. Serves as product quality and compliance resource during planning and execution of major changes for assigned commercialized global products. Co-ordinate the change control program for changes impacting products manufactured at assigned TPMs and Suppliers. Prepare Quality/Technical Agreements to align with the legal contracts. Support a program/project management process to support quality and compliance initiatives at TPMs. Participate on QA cross-functional teams to support TPMs and Suppliers , as necessary. Travel to off-site locations to ensure and aid the quality infrastructure and appropriate quality systems for alignment to QA Supplier or Third Party Manufacturing Quality or Technical Agreements. Support the management of critical exception documents and CAPA. May act as the primary quality review and decisions maker for relevant TPM and Supplier exception documents for impact on product quality, safety, efficacy and impact to the regulatory filing. Ensure the appropriate GMP requirements are met for the validation of the product, process, equipment and facility. Be the final approver of these documents. Coordinate and approval activities to support follow-up on complaint trend investigations for non-medical and medical (adverse events) complaints. Prepare, review and approve Annual Product Quality Reports to ensure accuracy, completeness, timeliness, and those trends are identified and addressed in an appropriate manner. Support the TPM and Supplier QA management and approval of exceptions documents and CAPA’s elevated by Suppliers and TPMs and ensure that where appropriate senior Quality management are notified. For assigned TPMs and Suppliers, complete quality review meetings that identify and address quality, operational, and organizational issues. Support TPM/Supplier Quality Heads in providing quality and compliance support/advice for drug substance manufacturing at API suppliers and finished dosage form product manufacturing, packaging, and labelling to the TPMs. Support the pre-approval inspection readiness at TPM to ensure regulatory approvals are obtained, with no delays to market entries.

D. SUPERVISORY OR MANAGERIAL RESPONSIBILITY

Frequent contact with Abbott personnel at many levels, Divisions and Affiliates Close contact with TPM and Supplier personnel at all levels Continuous contact with Quality Manager and Director and appropriate Workstream Teams.

E. EDUCATION:

A 3rd level degree in a relevant Quality or technical/scientific discipline.

F. EXPERIENCE:

Comprehensive understanding of pharmaceutical manufacturing for finished dosage forms with 5- 8 years in QA, Operations, or Technical Support in a pharmaceutical setting.

Manufacturing related experience in some of the following areas: sterile, liquid, solids or API’s.

Audit experience of suppliers in pharmaceutical industry

Troubleshooting and issues resolution skills.

Project management expertise.

Perceptual and analytical problem solving related to removal of obstacles, setting priorities, people, resources and facilities involvement.

Ability to communicate effectively, both orally and in writing to both internal and external audience.

Teamwork attitude and capability of understanding and overcoming different cultural and language obstacles to provide solutions satisfying corporate, divisional and local objectives.

Ability to use Quality Risk Management tools.

G. PROBLEM SOLVING:

Capable of understanding and overcoming different cultural and language obstacles to provide solutions that satisfy corporate, regional, and local objectives.

Capable of analysing data in order to support the development of strategies to effectively manage the action plans that will resolve the issues.

H. ACCOUNTABILITY/Scope:

Responsible for ensuring that TPMs and Suppliers maintain compliance with local and International regulations as required by markets supplied and ensuring that the quality systems are appropriate so that the product safety, efficacy and quality are maintained. Within the accountability and scope of this role, all the Core Job responsibility associated with TPM and Supplier and product quality assurance & compliance of commercialized product of global/multiregional scope. The position receives supervision through regular meetings with Quality Manager.

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