Compliance Assessor Senior - Berkshire
Rob Walker at CK Science is currently recruiting for a Senior Compliance Assessor to join one of the world's largest pharmaceuticals, consumer health and biologics companies. Based at their site in Berkshire, this role is offered on a full time temporary basis for 12 months.
Your main responsibilities in this role will be to:
- Perform compliance review of product manufacturing and quality documentation to cGMP, company internal standards and industry requirements
- Review existing manufacturing site product and material specifications, validation protocols and reports, stability protocols and reports, Periodic Quality Reviews, change controls, product quality complaints, CAPAs, manufacturing batch documentation and dossier
- Complete a cGMP Compliance Recording Form and Product Health Assessment Form
- Request any additional documentation / translations of existing foreign language documentation if any gaps are identified
- Review and approve protocols and reports from the manufacturing site and/or CRO that control the required remedial work, i.e. process or analytical revalidation
- Prepare Expert Statements to support regulatory submission
You are required to have the following qualifications, skills and experience:
- Bachelors degree with a major in chemistry, chemical engineering or pharmaceutics or equivalent degree
- Pharmaceutical manufacturing or product development environment with a major emphasis on API manufacture and multi-ingredient finished dose formulations.
- Experience with non-prescription ingredients used in cough, cold & allergy preparations and analgesics is a distinct advantage. Experience with flavouring technologies is an advantage.
- Comprehensive understanding of quality compliance knowledge within EU and good understanding of GxP systems
- Technical writing and documentation review abilities
If you are employed by this client you will be joining a global pharmaceutical company based in Buckinghamshire.
For more information or to apply for this Compliance Assessor position please contact Rob on +44 (0)1246 457700 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Science is an Equal Opportunities employer who 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 SH34737 in all correspondence.