QA Manager

Job Description : QA Manager Alfacare (BDR Group), Algeria Position: QA Manager Location: Algeria Experience: 10+ years Industry: Pharmaceutical (OSD & Injectables) Company Overview: Alfacare, a group company of BDR Pharmaceuticals, is setting up a new pharmaceutical manufacturing facility in Algeria. As part of this expansion, we are seeking an experienced and dynamic QA Manager to lead the Quality Assurance (QA) function from its inception. The ideal candidate must have expertise in both Oral Solid Dosage (OSD) and Injectables and will be responsible for setting up all QA processes, equipment validation, vendor qualification, and regulatory compliance. This is a Cytotoxic Plant requiring strict adherence to safety and regulatory guidelines. Key Responsibilities: 1. Quality System Development & Implementation: • Establish and oversee Quality Assurance (QA) systems from scratch for the new facility. • Develop and implement Standard Operating Procedures (SOPs), policies, and guidelines to meet regulatory and company standards. • Ensure compliance with cGMP, WHO, EU, and other applicable regulatory guidelines. 2. Equipment & Vendor Qualification: • Lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for all new equipment. • Perform vendor audits and qualification for raw materials, packaging materials, and critical components. • Establish and oversee a robust supplier and vendor qualification system to ensure material quality compliance. 3. Validation & Qualification Activities: • Oversee process validation, equipment qualification (IQ, OQ, PQ), and method validation. • Lead cleanroom qualification, HVAC validation, water system validation, and utilities qualification. • Ensure the validation master plan is in place and executed as per regulatory standards. 4. Regulatory Compliance & Audit Preparation: • Ensure the site is prepared for regulatory inspections from WHO, EU, and local Algerian authorities. • Liaise with regulatory bodies, auditors, and third-party agencies for audits and certifications. • Maintain compliance with all documentation, batch records, deviations, CAPAs, and change controls. 5. Quality Control & Manufacturing Oversight: • Work closely with Production, QC, and Engineering teams to ensure a quality-driven culture. • Ensure good documentation practices (GDP) and data integrity in all QA activities. • Monitor and review deviation reports, OOS (Out of Specification) results, and risk assessments. 6. Training & Team Development: • Establish training programs for staff on quality systems, compliance, and cGMP requirements. • Build and mentor the QA team for long-term sustainability and efficiency. Key Skills & Competencies: Strong knowledge of cGMP, WHO, EU, and other international regulatory standards. Hands-on experience in both OSD and Injectables manufacturing. Expertise in equipment qualification, FAT/SAT, validation, and vendor audits. Strong analytical skills to assess quality risks and implement proactive solutions. Excellent documentation, communication, and leadership abilities. Ability to work in a start-up manufacturing environment and build systems from the ground up. Qualifications & Experience: • B.Pharm / M.Pharm / M.Sc. in Pharmaceutical Sciences or related field. • 10+ years of experience in Quality Assurance (QA) in a pharmaceutical manufacturing setup. • Must have experience in handling both OSD and Injectable dosage forms. • Experience in setting up QA systems for new manufacturing facilities will be highly preferred. Why Join Us? • Opportunity to set up and lead the QA function for a new world-class pharmaceutical facility in Algeria. • Be part of a growing and dynamic international pharma group with strong industry reputation. • Work in a challenging and rewarding environment with exposure to global regulatory standards. • Competitive compensation and career growth opportunities within BDR Pharmaceuticals and Alfacare.

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