Engineering Support Officer - Grangemouth
Are you looking for the opportunity to join a global pharmaceutical company? We are currently recruiting for an Engineering Support Officer to join a pharmaceutical company on a 12 month fixed term contract basis at their offices in Grangemouth.The Company: Our client is a global pharmaceutical company who specialise in a comprehensive range of development services to help the customer address complex drug development challenges and bring more products to the market faster. They manufacture services for a wide variety of solid dose forms. They have global manufacturing sites located across North America, Europe and India that offer the highest standards of quality and service to their customers.
Location: This role is located in Grangemouth, easily commutable from the M9, M80 and many other transport links.
- Provide input to support department QMS activities including creation, review and completion of change control, deviations/investigations, CAPA, Effectiveness Review, Actions and related records.
- Generate, review and update support department Standard Operating Procedures, Operating Instructions, Critical Instrument lists, Periodic Reviews, Risk Assessments and other documentation as required by internal procedures and regulatory/guidance requirements.
- Lead and document support department investigations, ensuring effective CAPA as appropriate.
- Identify and ensure any identified QMS, GxP, Good Engineering Practice gaps or areas of concern are appropriately escalated and addressed.
- Participate in qualification and validation activities including generation, review and approval of documentation.
- Ensure all documentation and records are controlled, maintained in archived as appropriate.
- Support the preparation for customer, MHRA/FDA and other regulatory body audits.
- Ensure a culture of 'Audit Readiness' is promoted within support departments.
- Identify and support implementation of continuous improvement initiatives.
- Knowledge and experience of Quality Management System Requirements and/or Good Engineering Practice in a pharmaceutical/medical devices or diagnostic setting.
- Experience of updating, creating and approving Quality/Engineering documentation; e.g. SOPs, Work Instructions, Testing/Validation Certificates & Reports.
- Experience and knowledge of leading and recording investigations associated with deviations.
- Use of investigation, root cause analysis and risk management tools.
- Understanding of change management/change control principles.
- Generating and reporting Key Performance Indicators.
- Familiar with process improvement concepts.
The Benefits: The company is offering a fixed term 12 month contract.
For more information or to apply for this Engineering Support Officer position, please contact Keir Betts on 01246 457 710 or firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46080 in all correspondence.