Cpl Life Sciences are partnered with a leading pharmaceutical company for a QC Technical Project Manager, the role includes overseeing a team of technical specialists managing the laboratory electronic systems (LIMS & CDS), introduction and maintenance of technology & equipment, and compliance associated activities (global change, method transfer, pharmacopeia reviews, new product information).
Job description:
• Manage a team of QC Technical Specialists, ensuring regular 1:1 meetings, updated job descriptions, objectives, and timely performance reviews. Monitor team resource needs through capacity planning.
• Oversee procurement, validation, qualification, and deployment of new QC Equipment and Systems, ensuring robust project management and compliance with the company policies.
• Provide technical support for the operation, maintenance, and improvement of QC Equipment and Systems, troubleshooting issues, promoting best practices, and escalating concerns as needed.
• Approve validation documents, SOPs, training materials, and change controls to ensure compliance with procedures and regulatory requirements.
• Lead compliance activities, including deviation management, global change control, regulatory submissions, and adherence to pharmacopeias.
• Collaborate with vendors for technical support and respond to global regulatory equipment/method queries.
• Advocate for Data Integrity practices and identify opportunities for continuous improvement.
• Support internal and external audits, authority inspections, and escalate quality issues to the Head of QC.
• Perform additional duties as directed by the Head of QC.
Requirements:
• Degree in a science discipline or equivalent experience.
• Strong knowledge of pharmaceutical QC equipment and electronic systems, including qualification, validation, and technical management (minimum two years).
• Experience as a lab administrator or end-user of QC electronic systems.
• Proficient in analysing user requirements, driving system improvements, and maintaining data integrity.
• Strong technical judgment and ability to interpret complex data and present findings clearly, and computer literacy with knowledge of GMP guidelines and regulations.
• Excellent communication, people management, and relationship-building skills for internal and external projects.
Apply within, or please reach out to [email protected] for more information.