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Compliance Specialist, Pharmaceutical Industry

2 weeks ago

Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full time

Are you interested in a challenging role that involves Marketing Authorisation responsibilities and opportunities to work globally across multiple cultures?

We are seeking a full-time Quality Assurance Manager with GMP and GDP experience to support cross-functional collaboration at ALK Headquarters and with external partners and affiliates worldwide.

Responsibilities:
  • Developing and improving business processes within ALK and with external partners, ensuring oversight and maintenance of quality standards.
  • Batch record review, complaint handling, deviation handling, change management, supplier management, audit management, and documentation reviews.
  • Collaborating with internal departments and external partners in the supply chain, providing operational support and sparring.
  • Conducting audits of external partners, including CMOs, warehouses, distributors, and transporters.
Requirements:
  • Minimum 5 years of experience in Quality departments, production sites, or supply chain departments.
  • Experience with internal audits and audits of external partners is an advantage.
  • B.Sc. / M.Sc. in Health Science or equivalent, with strong knowledge of quality management systems and tools.
Personal Qualities:
  • Strong drive and ability to take own initiatives and proactive action.
  • Ability to work respectfully across different cultures, with flexibility and excellent communication skills.