Proclinical is seeking a Quality Control Compliance Specialist to oversee the introduction and management of laboratory equipment, ensuring timely implementation to support product testing. The successful candidate will be part of a dynamic team driving continuous improvement initiatives within the Quality Control department.
Responsibilities:
1. Generate and review documentation such as User Requirement Specifications (URS), GxP assessments, Standard Operating Procedures (SOPs), and Work Instructions (WIs).
2. Approve documentation related to Installation Qualification (IOQ), Performance Qualification (PQ), and SOPs.
3. Manage the upgrade and introduction of analytical instruments in the QC laboratory, including UPLC, HPLC, Biacore, and others.
4. Facilitate and manage Change Control Requests for QC instrument introduction.
5. Collaborate with project managers to meet project timelines and milestones.
6. Coordinate with Validation, QA, IT, Metrology, QC Analysts, and other teams for alignment on qualification and validation strategies.
7. Conduct duties safely and report any safety concerns.
8. Ensure timely completion of all required training.
Key Skills and Requirements:
9. Strong communication skills, both interpersonal and written.
10. Ability to work collaboratively across different levels and sites in a multinational environment.
11. Self-directed with strong initiative to resolve issues.
12. Educational background in science or related discipline, or relevant experience.