Job Title: Consultant - PQ Documentation for API Manufacturing Filling Line
Location: Copenhagen, Denmark
Job Type: Contract/Consultant (8 months)
Start Date: ASAP
We are looking for an experienced Consultant to focus on Performance Qualification (PQ) documentation for our API manufacturing filling line. The role involves developing and managing PQ documentation, ensuring regulatory compliance, and collaborating with cross-functional teams.
Key Responsibilities:
- Develop and maintain PQ documentation.
- Oversee and execute PQ activities.
- Ensure compliance with regulatory requirements.
- Collaborate with Quality Assurance, Manufacturing, and Engineering teams.
- Provide training on PQ processes.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Engineering, or related field.
- Minimum 5 years of experience in pharmaceutical manufacturing.
- Strong knowledge of regulatory requirements for API manufacturing.
- Excellent documentation and analytical skills.
Preferred Qualifications:
- Experience with automated filling lines.
- Certification in Quality Assurance.
- Familiarity with electronic documentation systems.