Compliance Assessor

GENERAL JOB SCOPE:

To perform compliance review of product manufacturing and quality documentation to GMP internal standards and industry requirements; using the standardized processes and procedures in support of compliance project

MANUFACTURING AND QUALITY COMPLIANCE SUPPORT WOULD INCLUDE BUT NOT BE LIMITED TO

- 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.
- Request any additional documentation/translations of existing foreign language documentation if any gaps are identified.
- Update the Validation Master Plan with current data and any remedial work.
- Carry out a Preliminary Risk Assessment
- Complete a cGMP Compliance Recording Form and Product
- Health Assessment Form.
- Based on the regulatory variation strategy develop a manufacturing/analytical plan for the remediation work to ensure compliance.
- Request a quote for the works to be completed at the relevant manufacturing site and/or contract research organization (CRO) and agree a timescale for the works to be completed.
- Review and approve protocols and reports from the manufacturing site and/or CRO that control the required remedial work, ie process or analytical revalidation.
- Prepare Expert Statement to support regulatory submission
- Support request for information requests which may arise on regulatory variation submission
- Update Specification systems such as GSS, CONNECT, etc.
- You will be expected to be the primary contact for product manufacturing and quality reviews and remediation.

WORK EXPERIENCE:

- A minimum of 8 years in a 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 an advantage.
- Comprehensive understanding of quality compliance knowledge within EU and good understanding of GxP systems
- A demonstrated business partner and ability to bring together multi-disciplined technical staff in order to problem-solve.
- Technical writing and documentation review abilities
- Project management, communication and prioritization skills.
- Demonstrable experience of working with external manufacturers.
- Preferred raw material and product registration requirements.