Senior QA Lead for Pharmaceutical Operations
hace 4 días
**Job Overview:**
We are seeking a highly skilled Senior QA Specialist to join our team at Alk Nordic A/S. This role will play a crucial part in ensuring the quality and compliance of our pharmaceutical products.
Estimated Salary: DKK 550,000 - 650,000 per annum
Job Description:
The Senior QA Specialist will be responsible for maintaining internal Quality Systems, including change control, deviations, CAPA, and review of GMP technical and validation reports. They will provide quality support to technology transfer projects, assist in resolving GMP issues, and help maintain a permanent inspection readiness status.
Responsibilities:
- Perform Quality Assurance activities associated with maintaining internal Quality Systems: Change control, Deviations, CAPA, etc.
- Review GMP technical and validation reports: Manufacturing and packaging processes, Computer/Automated systems involved in testing, manufacturing or materials control, Cleaning Validation/Equipment cleaning procedures, Laboratory and manufacturing equipment qualification, Facilities and Utilities with product contact, Analytical methods validation.
- Provide quality support to technology transfer projects.
- Provide on-site guidance in the preparation of procedures and working instructions.
- Assist in providing resolution to GMP issues through identification of problem areas, refinement of systems, training and coaching of relevant personnel.
- Help support a permanent inspection readiness status.
- Provide QA support for regulatory filings.
- Prepare documentation for Material Review Board presentation and meetings.
- Support QA Management as required.
Requirements:
To be successful in this role, you will need:
- A minimum of 5 years' experience in the pharmaceutical/biotech industry.
- A thorough knowledge of quality systems, GMP, and regulatory requirements.
- A university degree in Chemistry, Pharmacy, Biology, or equivalent.
- Fluent communication skills in English (both written and spoken).
- Thorough knowledge in sterile products regulation.
- Oral solids forms and technology transfer projects knowledge is valuable.
- Expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, data integrity regulation.
- Strong interpersonal and leadership skills in dealing with various cultures on non-routine matters in stressful situations.
About Us:
Alk Nordic A/S is a global pharmaceutical company that helps people living with allergy. We are passionate about making improvements that lead to better economy, quality, and social responsibility. As a member of our team, you will have the opportunity to work on challenging projects and contribute to the success of our organization.
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