Senior QC Specialist (System Support)
Full-time
Senior Executive
2 months ago
Key ResponsibilitiesAct as site representative in global Communities of Practice (CoPs) and Centers of Excellence (CoEs), ensuring effective communica.....
Key Responsibilities
- Act as site representative in global Communities of Practice (CoPs) and Centers of Excellence (CoEs), ensuring effective communication and alignment on analytical processes.
- Maintain the Site Validation Master Plan and procedures related to ALCM and CPV for GxP laboratory equipment, ensuring alignment with site Quality and Validation strategies.
- Oversee life cycle management of QC laboratory equipment, including qualification, maintenance, and obsolescence risk management.
- Lead compendial compliance assessments, method control trend reviews, and data evaluations; recommend method improvements as needed.
- Support annual product and method reviews and invalid assay trending programs.
- Ensure compliance of all QC lab equipment with GxP, GMP, and regulatory requirements.
- Develop and maintain metrics to monitor qualification activities and identify performance trends or issues.
- Oversee documentation and approval of qualification deliverables such as risk assessments, traceability matrices, and validation reports.
- Support regulatory inspections and audits, presenting relevant equipment and validation documentation.
- Lead continuous improvement initiatives in QC support processes and equipment management.
- Ensure implementation and maintenance of QC digital solutions, including data management and end-user administration.
- Provide technical leadership for major laboratory projects, validation/transfer protocols, and change control requests.
- Serve as technical system administrator for QC GxP computerized systems.
- Ensure all work complies with cGMP, HSE, and data integrity requirements.
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Chemistry, Engineering, or a related field.
- Minimum 5 years of experience in Quality Control within the pharmaceutical or biopharma industry.
- Strong knowledge of GMP, GxP, and regulatory requirements.
- Hands-on experience in analytical method validation, laboratory equipment qualification, and digital laboratory systems.
- Proven ability to lead investigations, manage CAPAs, and support audits/inspections.
- Excellent communication, documentation, and cross-functional collaboration skills.
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