TPM/TT QA Manager

3 weeks ago

Jeddah, Makkah Province, Saudi Arabia Abbott Healthcare Pt Ltd Full time
About the Role

We are seeking a highly skilled Quality Assurance Manager to join our team at Abbott Healthcare Pt Ltd. As a Quality Assurance Manager, you will be responsible for ensuring the quality of our pharmaceutical products and services.

Key Responsibilities
  • Regional TPM Quality:
    • Provide QA support for assigned TPMs 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.
    • Monitoring quality performance for assigned TPMs/suppliers and ensuring requirements per Quality Technical Agreements are adhered to 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.
    • 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 coordination 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 of 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 in 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 meets the Quality Standards.
    • Facilitate issue resolution for key investigation and compliance issues.
    • Involve in supporting the quality aspects of the Product Portfolio Expansion, Geographic Expansion initiatives NPI (New Product Introduction) and other Non-Centrally Supported Products.
    • Support the lifecycle management strategy and support its operational execution as supporting the work-stream team or equivalent cross-functional team.
    • Manage 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 Manufacturers (TPMs) within the EPD division.
    • Provide Quality Leadership in the Regional EPD team structure.
    • Liaison between sites QA, commercial affiliates, MS&T (Manufacturing Science and Technology) and other groups as necessary.
    • Act as Regional NPI Coordinator for Geo-Expansion, L&A (License and Acquisition) and different projects.
    • Conduct/assist in due-diligence audits for new API suppliers to provide a rapid and accurate usage decision on proposed suppliers.
    • Serve as quality technical resource of regional EPD Quality organization during process and regulatory deficiency issues, risk assessment target cost initiatives and other continuous improvement initiatives.
    Requirements
    • Bachelor's degree in chemistry, Pharmacy, Medical Science.
    • 8+ years of supervisory experience in the pharmaceutical (Quality, Production, R&D etc.) or related fields.
    • GMP/GLP/GCP background related to medicinal products, medical device, food supplement Biotechnological, Biosimilars and Biologics.
    • Good communication and report writing skills in English and Arabic.
    • Strong leadership skills in bringing the best out of people, managing work teams and fostering teamwork within the department.
    • Strong strategic Planning/Thinking, decisive judgement, and Implementation skills.
    • Flexible for Travel: 40 %

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