Senior Quality Assurance Officer - Validation Specialist
Chemical Life Sciences Pharmaceuticals
Salary Up to £40,000 per annum
CY Partners are currently looking to recruit a Senior QA technician (Validation specialist) on behalf of a growing Pharmaceutical manufacturer based near Middlesbrough.
The main responsibility of this role will be to oversee quality aspects and documentation of validation activities onsite (both production and laboratory) as well as supporting the rest of the quality team in general PQS/QMS management. It is an exciting opportunity for the successful candidate to create new ways of working and to develop and build on the existing process.
Within the Quality team, they are aiming to create a flexible, multi-skilled team, enabling continued support to the business whilst allowing a good work-life balance.
The main duties of the role will be:
- To ensure the Site Validation Master Plan (SVMP) is maintained accurately and Validation Plans are implemented by working with multi-disciplinary teams across site
- Ensuring that validation activities are in compliance with regulatory standards internal SOPs and current industry best practices.
- creation of technical documentation including, but not limited to VP, URS, IQ, OQ and PQ.
- Providing quality oversight for documents and activities generated from other areas of the business.
- Provide support in achieving / maintaining compliance with EudraLex – Volume 4: Annex 11, GAMP guidelines and 21CFR part 11.
- Supporting regulatory audits.
- Involvement in change management either as change owner or technical assessment as validation SME.
- Ownership of other quality systems aligned to experience and/or personal development goals potentially including deviation management, QRM, CAPA, supplier management or change management.
The exact breakdown of responsibilities will be tailored to the individuals interests and skills.
The ideal candidate will have a solid grounding in validation either through Quality oversight or hands on execution in production and/or laboratory environments.
The role is multi-faceted and includes liaising with a wide variety of on-site production and operations teams, this position would suit a self-motivated individual who has demonstrable experience of working in cross-functional teams.
Required Qualifications and skills
- Degree Qualified ideally in Chemistry or related field (Engineering candidates also encouraged)
- Direct experience in and ability to apply GxP principles
- Experience in manufacturing processes and/or quality role
- A good understanding of validation principles and requirements in a range of settings (for example laboratory, production or computerised systems.
- Experience working with cross functional teams and influencing people at varying levels of the business.
- General experience working with a PQS/QMS with knowledge of key areas e.g. change management, deviation management, QRM
- Knowledge of DMF structure and pharmacopoeia