Senior QC Equipment Officer in Morpeth

Piramal Pharma Solutions is a contract development and manufacturing organisation (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialised services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Plans and prioritises laboratory support for the QC team, setting work schedules for yourself. Supporting the QC team ensuring safe, effective and efficient working, in accordance with cGMP and in line with business requirements.

• Responsible for equipment replacement and upgrade program.
• Generation, review and approval of QC equipment qualification/validation documentation.
• Co-ordinate instrumentation repairs and PM-PV visits for laboratory instrumentation.
• Act as specialised instrument super user.
• Control and manage the maintenance and calibration schedule for the area.
• Support the execution of the QC Optimisation Plan initiatives, driving continuous improvement of the QC department.

ESSENTIAL QUALIFICATION: The holder will normally be expected to be qualified in a technical or scientific area which is relevant to the role. This may be through a formal educational/qualification route or via relevant experience and training obtained through practical application. It may also be a combination of both. Strong leadership skills are essential.

RELEVANT EXPERIENCE: Educational/industrial experience appropriate for the role.

Critical Tasks:

• Ensure existing laboratory instrumentation is maintained and calibrated appropriately through effective communication with external and internal engineer support.
• Provide instrument qualification/validation documentation, including relevant trackwise controls prior to setup and qualify appropriately.
• Set work schedules and priorities, escalating any issues or concerns that may impact the delivery of business commitments.
• Collect and collate data to facilitate the management of the performance, efficiency and utilisation of QC equipment.
• Effective communication relating to QC equipment activities within the business and to external customers, providing key performance indicator metrics as appropriate.
• Ensuring computerised systems and equipment maintenance and validation is performed on time and in line with business requirements and is performed by suitably trained and experienced analysts and in with cGMP and EHS as required by regulatory and company directives.

Critical Skills:

• Strong leadership skills – ability to manage projects in busy environment and provide support to team members.
• Excellent planning and organisation skills.
• Effective communicator.
• Analytical technique expertise.
• Strong documentation skills and use of Microsoft office applications e.g. Word, PowerPoint.
• Strong knowledge of cGMP requirements for QC laboratories.

Key Duties:

• Assists with laboratory maintenance/calibrations/validations and tasks for a QC team, within a large QC department, that provide DI compliant QC data to support GMP decision making across the Morpeth business, to agreed standards of safety, cGMP, cost and cycle times.
• Support the QC team in the delivery of business commitments; ensuring all QC equipment is available for use in line with business requirements.
• Analytical Equipment laboratory investigations are resolved, reviewed and approved in a timely manner.
• Resource allocations are managed to ensure customer demands are met through liaison with the QC Managers, Supply Chain planners, SLT and external contractors.
• Maintain QC OTIF in line with customer requirements – support ‘getting tablets to patients’.
• Provide direct QC equipment support to the QC Team.
• Write, review and approve QC equipment procedures and validation documentation.
• Drive equipment deviation and safety investigations, ensuring investigations are appropriate and root causes are identified where applicable.
• Appropriate CAPA identified, implemented and the closure is in line with defined timelines.