Quality Assurance Manager

BDR Pharmaceuticals

Job Description: QA Manager Alfacare (BDR Group), Algeria

Position: QA Manager

Location: Algeria

Experience: 10+ years

Industry: Pharmaceutical (OSD & Injectables)

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.