PEGlobal are looking for an Interim Production Validation Specialist for our multinational pharmaceutical client based in the Berkshire area.
General Job Scope:
• To perform compliance review of product manufacturing and quality documentation to cGMP, the companies internal standards and industry requirements; using the standardized processes and procedures in support of compliance project.
• Execute the remediation work relating to the identified gaps by the compliance review at third party manufacturers and/or the companies internal sites.
Manufacturing Validation support would include but not be limited to;
• Review existing manufacturing site product and material specifications, validation reports, stability reports, Periodic Quality Reviews, change controls, product quality complaints, CAPAs, manufacturing batch documentation and dossiers, against cGMP, the companies internal standards and industry requirements
• 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.
• Complete the identified gaps into the standard documentation.
• 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.
• Prepare Expert Statement to support regulatory submission
• Support request for information requests which may arise on regulatory variation submission
You will be expected to be the primary contact for product manufacturing and quality reviews and remediation.
Educational – Minimum of Bachelors degree with a major in chemistry, chemical engineering or pharmaceutics or equivalent degree.
• A minimum of 8 years in a pharmaceutical manufacturing or product development environment with a major emphasis on 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.