Tpm/tt QA Manager

4 months ago

جدة, Saudi Arabia Abbott Laboratories Full time

**The Opportunity - Third Part Manufacturer and Technical Transfer QA Manager
- METAP&CIS**

This position works out of our Saudi Arabia affiliate in the Established Pharmaceutical division (EPD) and is part of METAP& CIS Region (Middle East, Africa, Turkey, Pakistan & CIS).

Established Pharmaceuticals are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

As **Third Part Manufacturer and Technical Transfer QA Manager,** you’ll be responsible for TPM QA Management and Product Technical Transfer.

**What You’ll Do**

**Regional TPM Quality**:

- Providing QA support for assigned TPM’s and/or Suppliers to ensure that safe, efficacious, and quality product can be supplied to Abbott METAP-CIS region to meet cGMP and other applicable regulatory standards and the appropriate market requirements.
- Responsible for development of Quality Improvement Plan for TPMs remediations, when required.
- Managing TPM & Supplier activities while driving continuous improvement for TPMs and Suppliers.
- Responsible for Monitoring quality performance for assigned TPMs / suppliers and ensure requirements per Quality Technical Agreements are adhered / followed by assigned TPMs and suppliers.
- Leading Quality Technical Agreements approval and renewal
- Primary contact for communication of TPM Quality issues as needed.
- QA support for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, and product release issues as needed.
- Responsible for maintaining regional Approved Supplier Listing.
- Responsible for communication with Global TPM/Supplier QA regarding Global TPM Products that are supplied for Saudi.
- Responsible for supporting Global and Regional Quality Compliance and improvement initiatives.
- Support new contract manufacturing site approvals within METAP-CIS region must approve all new contract manufacturers for EPD commercial product within responsibility.
- QA Lead for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, product release issues, PQR review and change control at TPM and supplier sites
- QA lead for co-ordination with TPMs & Supplier and internal cross functional team as support and interfaces for routine Quality requirements like GMP audits, new projects or initiatives.
- Analyzes data, makes decisions, or provides recommendations to senior staff regarding quality related issues & crises. Work cross functionally in identifying and resolving technical issues across different EPD regions.
- Recommends and implements changes to the system as the result of changing regulations and/or business needs.
- Coordinates across functional areas, business units, and/or geographies to achieve regional and affiliate goals.

**Product Transfer and Support QA**
- QA Lead for below quality activities during Product Transfer and ASQ including,
- Change Control / Stability and Change Impact Assessment
- Test Method Transfer/Analytical Method
- Validation/Verification
- Process Validation/Verification Program
- Stability program during Shelf-Life of the product Microbiological validation studies
- First lot quality review for release the validation batches for commercialization.
- Gather information from the Sending Unit, in order to assemble a data package.
- Evaluate the information gathered and document findings with respect to product robustness
- Participate to the process of creation, approval and continuous improvement of the regulatory documentation related to EPD products. Provide support for the specification setting to Regulatory Affairs and receiving unit.
- Provide contributions for the Product technical knowledge during and after technology transfer and ensure the product meeting the Quality Standards. Facilitate issue resolution for key investigation and compliance issues
- Involve in support the quality aspects of the Product Portfolio Expansion, Geographic Expansion initiatives NPI (New Product Introduction) and other Non-Centrally Supported Products.
- Supporting the lifecycle management strategy and supporting its operational execution as supporting the work-stream team or equivalent cross-functional team. Managing product and process quality and compliance throughout the maturity stage of the life cycle of EPD commercialized products
- Ensure that projects and technical activities associated with Drug Substances, Drug Products, Intermediates and non-pharma products (food supplement, medical device, cosmetics) are carried out without business interruptions and according to legal and Abbott Quality, Regulatory and business requirements.
- Contribute to the final decision making on the usage of new Third-Party

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