CQA LEAD BENELUX

☞ Talentus

看过: 145

更新日: 16-11-2025

位置: Lessines Hainaut

类别: 其他

行业: Chemical Manufacturing Biotechnology Research Pharmaceutical Manufacturing

水平: Associate

工作类型: Full-time

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工作内容

Functie
  • Responsible Person/Responsible Pharmacist:
– 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 …

– 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 QMS implementation:
– Be the QA management contact person for BDCE warehouse operations and Benelux business functions

– Develop and maintain Quality mindset in BDCE Operations

– 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 product 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
Functie-eisen
  • Must possess a 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, apply 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

Organisatie

Our client is a leader in medical innovations that are revolutionizing healthcare. If you too would like to contribute to the improvement of healthcare for patients, this is the place to be! We are recruiting a CQA LEAD BENELUX to join their team.
Aanbod

We offer you the chance to take on a managerial role in a leading company in its field. A long term contract and a very attractive salary, with very interesting extra-legal benefits.
Over ons

Talentus HR experts will put you in touch with your future employer. These passionate specialists work mainly for Belgian SMEs. Their mission is to select the best talents and to find you a tailor-made job.
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最后期限: 31-12-2025

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