Quality Head / GDP Responsible Person

For our Client, a multinational company in the pharmaceutical industry, we are looking for a Candidate for the position:

Quality Head / GDP  Responsible Person

Warsaw/Błonie

MAIN RESPONSIBILITIES AND DUTIES:

• Ensures that processes and procedures comply with applicable legal regulations and internal corporate policies.

• Oversees the wholesale distribution authorization and related changes.

• Represents the company during Regulatory Authority inspections and ensures positive outcomes.

• Reports to Regulatory Authorities in accordance with applicable laws and maintains communication with them.

• Acts as the leader of the Annual Quality Review process, reporting to the local CEO and corporate functions.

• Serves as the SPOC with HQ, particularly in matters related to MAH representation.

• Manages the product recall process.

• Oversees compliance of packaging materials for medicinal products.

• Is responsible for Quality Agreements.

• Supervises the key Logistics Service Provider (LSP) for storage and transportation.

• Manages the quality system at the organizational level in Poland, including implementation of legal and corporate requirements.

• Implements and promotes the Quality Policy.

• Approves quality documentation.

• Is responsible for quality audits and internal inspections within the Polish entity.

• Acts as a GMDP auditor at the corporate level.

• Manages quality training and personnel qualification.

• Oversees quality risk management.

• Manages complaints, deviations, and CAPA processes.

• Oversees premises, equipment, and computerized systems in the pharmaceutical warehouse.

• Supervises operational activities and documentation.

• Oversees quality control and qualification of local GxP service providers and subcontractors.

• Directly manages a 3-person team.

REQUIRED QUALIFICATIONS, EXPERIENCE AND SKILLS: 

• Education:

  - Higher education in pharmacy (Master of Pharmacy) and active license to practice as a pharmacist

• Experience:

  - Work experience in the Quality Department, Pharmaceutical Wholesale or in the manufacturing area

• Qualifications:

  - Very good knowledge of Pharmaceutical Law, GxP rules, Good Distribution Practice (GDP) and other regulations necessary for the role
  - Ability to create procedures and process maps 

• Eligibility and Systems:

  - TrackWise system support (deviation management, audits, CAPA)
  - Supervision of GxP documentation in eDMS system
  Esker, SAP

• Abilities:

  - Ability to manage a team
  - Very good work organization and prioritization
  - Accuracy and detail orientation

• Other Requirements:- Very good knowledge of MS Office package
  - Very good knowledge of English - spoken and written