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GMP Manufacturing Subject Matter Expert

  • Job reference: LMMSME
  • Location: Maidenhead, Berkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 01/10/2018

OTC finished product manufacturing SME with RA, Quality/GMP & regulatory experience.

Reports to Technical Project Manager OTC GTO - EMEA

Location Maidenhead

Scope of the Role:
To perform a gap analysis review of production documentation against the following:
* registered documentation,
* current cGMP,
* nternal standards,
* Industry standards e.g. ICH.

Standard processes and procedures have been developed to support this compliance review. The applicant will also initiate and oversee the remediation activities to close any gaps identified..

The gap analysis review will include but not be limited to;

* Review of the existing manufacturing site documentation will include e.g.
* Product and material specifications,
* validation documentation,
* stability documentation,
* Periodic Quality Reviews, complaint history and any CAPA produced as a result,
* change control history,
* CAPAs,
* manufacturing batch documentation
* Regulatory dossier
* Request additional documentation as required
.
* Carry out a Preliminary Risk Assessment The gap analysis will be completed using the relevant documentation to detail the cGMP Compliance and Product Health Assessment.
* Carry out a Risk Assessment on the findings to prioritise activity
* 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, i.e. process or analytical revalidation
* If required, prepare an Expert Statement to support regulatory submission
* Support request for information requests which may arise on regulatory variation submission
* Update Specification systems as required.
.
* 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.


Key Internal Stakeholders;
Supply Chain - Manufacturing
Regulatory Affairs
Quality Assurance
Project Management

Experience Required


Educational - A relevant degree or suitable pharmaceutical industry experience.

Work Experience:


* A minimum of 8 years in a pharmaceutical manufacturing or product development environment
* Knowledge and understanding of different manufacturing processes used with the OTC environment is a distinct advantage.
* Comprehensive understanding of quality compliance knowledge within EU and good understanding of GxP systems
* Technical writing and documentation review abilities
* Project management, communication and prioritisation skills.
* Demonstrable experience of working with external manufacturers.
Preferred understanding of EMEA regulatory processes and requirements.


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.