Quality Compliance Auditor At Abbott
OVERVIEW
Abbott Established Pharmaceutical business in Egypt is looking for a Quality Compliance Auditor reporting to the Regional Due Diligence QA Head.
The Quality Compliance Auditor will support product Due Diligence Audit for License and Acquisition (L&A) Deal, On-site GMP Due Diligence Audit, and Governance on CAPA and conditions closure of signed deals to enhance product launch in the METAP region.
WHAT YOU'LL DO:
Participate in the approval all new contract manufacturers for EPD commercial product within responsibility.
Responsible to participate in projects assigned as Quality compliance auditor for all METAP product acquisition, in-licensing deals and or distribution deals.
Responsible to support in establishing and implementing due diligence processes and procedures for the application into the quality & technical assessment of medicinal products, medical devices & consumer health products for new business opportunities.
Responsible for conducting on site GMP audit program for contract manufacturing sites and contract laboratories for METAP region, including all related activities for initial selection, due diligence, and ongoing surveillance, in accordance to regulatory and business requirements.
Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close for supplier and TPMs audits.
Responsible to provide support in contract drafting / negotiations for all new deals, contracts agreements and quality risk management (QRM).
Responsible to provide support in transitioning of TPM to TPM QA and Technology Transfer QA.
Manage quality questionnaires for Regional Suppliers, Third Party Manufacturers.
EXPERIENCE AND EDUCATION, YOU'LL BRING:
Bachelor’s degree in Pharmaceutical Science or Engineering Science.
5-7 Years’ Experience in working in Pharmaceutical Field.
Has an appropriate skill in GxP Auditing (Internal and/or External GxP Auditing).
High capabilities in time management, communication skills and Microsoft offices (Excel, Macros).
Experience in Computerized system Validation, software validation is highly preferred.
Experience in Clinical, product development and product design are highly preferable.
Certified Quality Auditor from recognized entity is highly preferred.
Fluency in English and Arabic is a must, French is an advantage.