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Quality Assurance Specialist
2 months ago
Job Title: Sr Quality Specialist
Job Summary:
We are seeking a highly motivated and detail-oriented Sr Quality Specialist to join our Quality Assurance team in Norway. As a Sr Quality Specialist, you will be responsible for ensuring compliance with regulatory requirements and site procedures, as well as planning and conducting internal and supplier audits.
Key Responsibilities:
- Collaborate with cross-functional teams to troubleshoot problems and ensure compliance with regulatory requirements.
- Plan and conduct internal and supplier audits to ensure compliance with site procedures and regulatory requirements.
- Manage environmental programs at the site and ensure compliance with regulatory requirements.
- Facilitate root cause and risk analyses to identify and mitigate potential risks.
- Serve as Quality Owner for corrective/preventive actions and ensure timely resolution of quality issues.
- Act as Quality Lead in Quality and Operational Projects and ensure effective communication with stakeholders.
Requirements:
- Bachelor's degree or Master's degree in biology, chemistry, biochemistry, chemical engineering, or a related field.
- Solid knowledge of GMP and/or ISO 13485.
- Experience as an internal or external auditor; certification as an auditor is an advantage.
- Experience in Change Control and CAPA/Root Cause Analyses.
- Experience in the Medical Device or Pharma industry is an advantage; alternatively, similar experience from the food industry, chemical, Oil & Gas industries, or from a relevant certification body/authority is acceptable.
- Fluency in Norwegian or other Scandinavian language in addition to English.
Personal Attributes:
- Solution-oriented and analytical with close attention to detail.
- Resourceful and accountable with a strong desire for continuous improvement.
- Excellent communication and interpersonal skills with the ability to work well with everyone at all levels.
What We Offer:
- A collaborative and dynamic work environment with a team of dedicated and helpful colleagues.
- Opportunities for professional growth and development in a senior role.
- Competitive benefits and company socials.
