Quality Control Manager

il y a 4 jours

Alger, Alger, Algérie MS PHARMA Temps plein

Job Scope
The QC Manager is responsible for managing and controlling production quality in the company's plants, both technically and administratively. The role ensures consistent pharmaceutical product quality by developing, enforcing, monitoring, and maintaining effective quality control systems. It also involves providing technical guidance to quality control teams, coordinating with other departments, and ensuring completion of analytical tasks and long-term stability studies.

Job Requirements

  • Education: Bachelor's degree or higher in Pharmacy, Science, or Chemistry.
  • Experience: Minimum 14 years of experience in pharmaceutical analysis,
  • Languages: Proficiency in written and spoken Arabic, French and English.

Professional Knowledge

  • Solid knowledge of ICH, GMP, and GLP systems.
  • Strong understanding of international and EU pharmaceutical regulations.

Main Competencies

  • Communication and decision-making skills.
  • Employee development and coaching.
  • Adherence to company policies and procedures.
  • Innovation, creativity, and cost consciousness.

Duties And Responsibilities

  • Oversee the design, implementation, and monitoring of the pharmaceutical quality system.
  • Ensure effective documentation systems for all quality elements (SOPs, batch records, testing procedures, etc.).
  • Approve specifications and master production instructions.
  • Ensure all materials and products are appropriately tested and results are accurately reported.
  • Supervise stability studies and product quality reviews.
  • Coordinate with internal departments and regulatory authorities (e.g., MOH, FDA) to ensure compliance.
  • Support and guide QC teams technically and administratively.
  • Conduct performance reviews, training, and manpower planning for the QC Department.
  • Participate in audits, investigations, and vendor validations.
  • Ensure the planning, execution, and review of all QC testing (raw materials, intermediates, bulk, finished products, packaging materials, stability samples).
  • Guarantee that all analyses are performed according to approved methods, validated procedures, and GMP requirements.
  • Ensure timely release of materials and products to support production planning and market supply.
  • Ensure strict application of GMP, GLP, and Data Integrity principles (ALCOA+).
  • Maintain compliance with pharmacopeias (USP/EP/JP) and regulatory guidelines.
  • Ensure proper documentation, traceability, and accuracy of QC records (logbooks, notebooks, instruments, CoA, reports).
  • Ensure laboratory housekeeping, equipment maintenance, and safety rules.
  • Manage laboratory inventory (standards, reagents, columns, consumables).
  • Lead investigations related to OOS, OOT, deviations, and lab incidents.
  • Escalate critical issues and ensure timely communication to QA and management.
  • Implement Laboratory improvement initiatives (LEAN, 5S, digitalization).
  • Reduce analysis time, prevent deviations, and enhance data quality.
  • Monitor KPIs (lab performance, OOS rate, lead-time, CAPA closure).
  • Implement laboratory improvement initiatives (LEAN, 5S, digitalization).
  • Reduce analysis time, prevent deviations, and enhance data quality.
  • Monitor KPIs (lab performance, OOS rate, lead-time, CAPA closure).

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