Quality Control Manager

BDR Pharmaceuticals

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

Position: QC 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 QC Manager to lead the Quality Control (QC) function from its inception. The ideal candidate must have expertise in both Oral Solid Dosage (OSD) and Injectables and will be responsible for establishing the QC laboratory, managing analytical operations, and ensuring compliance with global regulatory standards. This is a Cytotoxic Plant requiring strict adherence to safety and regulatory guidelines.

Key Responsibilities

1. QC Laboratory Establishment & Management

- Set up and validate Quality Control laboratories, including chemical, instrumentation, and microbiology labs.
- Develop, implement, and maintain SOPs, test methods, and quality protocols.
- Ensure compliance with cGMP, WHO, EU, and other international regulatory requirements.

2. Analytical Testing & Method Validation

- Oversee analysis of raw materials, packaging materials, in-process samples, and finished products.
- Ensure timely release of materials and products while maintaining strict adherence to quality specifications.
- Lead analytical method validation, transfer, and stability studies in line with ICH guidelines.

3. Instrumentation & Technology Management

- Oversee qualification, calibration, and maintenance of critical instruments (HPLC, GC, UV, Dissolution, Particle size analyzer, etc.).
- Ensure compliance with data integrity and ALCOA+ principles in QC operations.

4. Regulatory Compliance & Audit Readiness

- Prepare and maintain documentation for regulatory inspections and audits.
- Liaise with QA, production, and regulatory affairs for submission data and compliance requirements.
- Ensure robust OOS, OOT, deviation, and CAPA management systems in QC.

5. Team Leadership & Training

- Build, train, and mentor a strong QC team across different sections (Chemical, Instrumental, Microbiology, Stability).
- Conduct regular training programs on analytical techniques, data integrity, and cGMP.
- Foster a culture of continuous improvement and compliance.

Key Skills & Competencies

Strong knowledge of cGMP, WHO, EU, ICH, and global regulatory standards.
Expertise in analytical testing, stability studies, and method validation.
Hands-on experience with sophisticated analytical instruments (HPLC, GC, FTIR, etc.).
Strong leadership and people management skills with experience in building QC teams.
Ability to work in a start-up environment and establish QC systems from scratch.
Excellent documentation and communication skills.

Qualifications & Experience

- B.Pharm / M.Pharm / M.Sc. in Pharmaceutical Sciences or Analytical Chemistry.
- 10+ years of experience in Quality Control in pharmaceutical manufacturing.
- Must have handled both OSD and Injectable dosage forms.
- Experience in setting up QC labs for new manufacturing facilities will be highly preferred.