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.
