We are looking for a Quality Assurance Lead.
- You act as Responsible Person (RP) for distribution. This includes assuring QMS functioning according to GDP guidelines including covering oversight on customer activation, code activation, returns, discards, administrative releases, complaints, Field Actions, subcontracted activities within the organization, …
- You act as Qualified Person (QP) as per ”preparation/MIA license” including final responsibility for final product certification, Annual Product Review, QMS in line with GMP etc…
Responsible for the clients QMS implementation:
- Be the QA management contact person for the warehouse operations and Benelux business functions.
- Ensure that operational processes with related procedures and procedures for release are in place and comply with the applicable requirements and cGDP.
- Ensure process and procedures are in place and in compliance with European, Local and Corporate requirements,
Responsible for CQA BDCE operational activities:
- Assure timely administrative release of all products received at the warehouse and set-up in IT systems.
- Be the local contact for Quality Audits and Supplier Quality.
Quality Support to local business initiatives in collaboration with Quality Operations.
- Master’s degree in Sciences, preferably in Pharmaceutical Sciences, or in (Veterinary) Medicine, Chemistry, Biology, Biomedical, to be in line with the local regulations for QP/RP.
- Demonstrated ability to develop and apply the clients operating philosophy and to operate within Company policies and procedures within Quality and Compliance area.
- Good verbal, written and presentation skills in English, to deal effectively with all levels of management.
- Team oriented worker with excellent interpersonal skills.
- Demonstrated ability to switch priorities and manage more than one project at the time. Ability to plan and conduct in projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical.
- Demonstrated ability to influence, collaborate and communicate directly and to lead cross functional and cross regional teams.
- Strong negotiating skills for interfacing with Health Authorities and market business functions.
- Demonstrated ability to effectively communicate ideas, lead and persuade others to accomplish challenging goals and objectives.
- 3-5 years of progressive managerial experience within the quality function of the pharmaceutical health care industry or with regulatory agencies.
- Very good knowledge and experience in pharmaceutical health care operations, quality control, distribution and International regulations are essential.
- Proficient in cGMPs, GDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9000 regulations; and requirements for pharmaceutical products distribution.
- French and English language skills.