About the Role
This position involves leading a laboratory team while applying technical expertise to support analytical testing of finished products and raw materials. All activities must be carried out in accordance with current Good Manufacturing Practice (cGMP), health and safety standards, standard operating procedures (SOPs), environmental guidelines, and regulatory requirements to ensure quality and customer expectations are consistently met. The role reports to a senior laboratory manager.
This is an on-site position based in a laboratory environment.
Key Responsibilities
- Lead and supervise a team of analysts, ensuring all testing complies with relevant regulatory and pharmacopeial standards.
- Plan, schedule, and coordinate laboratory testing activities.
- Maintain high standards of data integrity and regulatory compliance.
- Oversee team performance, including appraisals, development plans, attendance, and training records.
- Ensure testing schedules are met by managing workloads and tracking key performance indicators (KPIs).
- Review and approve laboratory data, protocols, and reports in a timely manner.
- Provide technical support for laboratory issues such as equipment or calibration failures and out-of-specification (OOS) results.
- Ensure all laboratory equipment is properly maintained and calibrated.
- Lead root cause investigations into analytical deviations and errors.
- Oversee method transfer activities within the team.
- Ensure compliance with SOPs, test methods, and relevant regulatory standards.
- Perform statistical trend analysis in line with GMP/GLP requirements.
- Support the review of laboratory documentation to ensure compliance with good laboratory practices (GLP).
- Manage laboratory inventory, including consumables and reference standards.
- Assist with regulatory inspections and customer audits.
- Ensure timely implementation of corrective actions arising from audits.
- Maintain and update GMP documentation in line with internal policies.
- Support the review and approval of SOPs.
- Drive continuous improvement initiatives within the laboratory.
- Carry out additional duties as required by management.
Education & Experience
- Degree in a science-related discipline.
- At least five years' experience in a regulated laboratory or pharmaceutical environment.
- Experience with analytical techniques, in particular HPLC.
- At least one year of experience within a leadership position in a laboratory.
- Demonstrated experience in team leadership and people management.
- Strong understanding of cGMP and relevant regulatory frameworks.
