Job Purpose
Lead and support the validation and life-cycle maintenance of site computer systems and analytical equipment in line with regulatory requirements.
Responsibilities
Co-ordinate and lead the validation and life cycle maintenance of site computer systems and analytical equipment as appropriate to ensure there is no break in the supply chain thus supporting Site objectives.
Coordinate, lead, and support the compliance activity in preparation for any regulatory audit and in response to current and any subsequent legislation affecting computer systems validation, analytical equipment validation, electronic records, and electronic signatures. This involves an approval and advisory role with respect to assessments and follow-up corrective actions.
To provide the necessary support, as required, for all levels of corporate, customer and regulatory audits, including face to face interaction with inspectors during internal and external regulatory audits (e.g. MHRA).
To deliver standardised training materials on Computer Systems and Analytical Equipment validation topics and deliver training as required.
Support standardisation of computer systems and analytical equipment validation processes, supporting roll out and adherence to these standard validation processes to deliver consistency and agility with cost benefits.
To understand the impact on ways of working relevant to Computer Systems and Analytical Equipment validation as required through changes in legislation.
Support the delivery of innovative strategies that are implemented by co-ordinating appropriate validation standards without adding significant cost to the business ensuring continuous improvement and long-term viability.
Act as Subject Matter Expert (SME) for computer system and analytical equipment regulations.
Support the development and use of systems within the wider networks and maintain links with Central IT, Quality, Shared Services, and other sites.
About you
Essential:
Degree in a relevant scientific/technical discipline (e.g. Chemistry, Biology, Engineering, Computer Science) or extensive industry experience in a comparable field.
Minimum 5 years’ experience in validation/quality roles within GMP pharmaceutical or closely related industry.
Strong, demonstrable experience of computerised systems validation, spreadsheet validation and laboratory equipment qualification.
Solid working knowledge of GAMP 5, 21 CFR Part 11 and related data integrity expectations, with practical application on site.
Able to write, review and challenge validation documents, and explain complex validation concepts clearly to less experienced colleagues.
Proven ability to work cross-functionally, influence stakeholders and represent validation during audits/inspections.Desirable:
Experience in API manufacturing or primary chemical/pharmaceutical operations.
Experience leading or significantly contributing to CSV / data integrity programmes at site or network level.
Prior experience mentoring or training in validation topics
