QC Technical Project Manager

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:

1. 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.
2. Oversee procurement, validation, qualification, and deployment of new QC Equipment and Systems, ensuring robust project management and compliance with the company policies.
3. Provide technical support for the operation, maintenance, and improvement of QC Equipment and Systems, troubleshooting issues, promoting best practices, and escalating concerns as needed.
4. Approve validation documents, SOPs, training materials, and change controls to ensure compliance with procedures and regulatory requirements.
5. Lead compliance activities, including deviation management, global change control, regulatory submissions, and adherence to pharmacopeias.
6. Collaborate with vendors for technical support and respond to global regulatory equipment/method queries.
7. Advocate for Data Integrity practices and identify opportunities for continuous improvement.
8. Support internal and external audits, authority inspections, and escalate quality issues to the Head of QC.
9. Perform additional duties as directed by the Head of QC.

Requirements:

1. Degree in a science discipline or equivalent experience.
2. Strong knowledge of pharmaceutical QC equipment and electronic systems, including qualification, validation, and technical management (minimum two years).
3. Experience as a lab administrator or end-user of QC electronic systems.
4. Proficient in analysing user requirements, driving system improvements, and maintaining data integrity.
5. Strong technical judgment and ability to interpret complex data and present findings clearly, and computer literacy with knowledge of GMP guidelines and regulations.
6. Excellent communication, people management, and relationship-building skills for internal and external projects.

Apply within, or please reach out to arshaan.sindhwani@cpl.com for more information.