Senior QA Specialist
19 hours ago
Job Overview
">Magle Biopolymers is seeking a highly experienced Quality Assurance Specialist to join their team. As a QA Specialist, you will play a critical role in ensuring the quality of our products meets regulatory requirements and industry standards.
About the Position
- You will be responsible for reviewing batch documentation and providing support to Deviations, Change Control, and CAPA processes.
- You will work closely with production peers to develop processes and find better, more efficient ways to work.
- You will participate in improvements and qualification/validation processes, manage changes, deviations, and complaints, and provide customer support.
Responsibilities:
- QA writing, review, and approval of Standard Operating Procedures (SOPs).
- Participate in customer and regulatory inspections, investigations, and risk assessments.
- Provide support within the team for qualification and evaluation of suppliers.
- Work collaboratively with the team to ensure the quality of our products meets regulatory requirements and industry standards.
Requirements
- Experience from Quality work for 5 years or more.
- University degree in chemistry, pharmaceuticals, or an equivalent engineering discipline.
- Previous work experience in pharmaceutical or Medical Device operations according to GMP part II and ISO 13485.
- Able to handle 'learning by doing' and willing to act even if there is a risk of mistakes.
- Lead by example, be a partner to production peers, be humble and open to learn and teach by doing.
- You must be able to work independently and to speak up when changes need to be addressed.
- Excellent proficiency in both Danish and English, spoken and written.
- Experienced user of Microsoft Office and electronic/paper Quality Management systems.
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