Process Validation Specialist

Process Validation Specialist

We are currently recruiting for Process Validation Specialist to join a Pharmaceutical organisation in Wales.

Role responsibilities:

Your role will be to ensure the validated state of all cGMP manufacturing and packaging processes. You will be responsible for adhering to standard operating procedures (SOPs) Health, Safety and Environmental Rules, General Data Protection Regulations (GDPR), Good manufacturing Practices (GMP) and other regulatory guidelines.

• To ensure the Site Validation Master Plan is adhered to and maintained in accordance with the required risk based, life cycle approach.
• To be a subject matter in at least one of the following disciplines: Manufacturing Process Validation, Packaging Process Validation and Continued Process Verification and able to represent that expertise at internal meetings, client facing meetings and at audit.
• To ensure timely generation of documentation for Manufacturing and primary packaging
• Process Validation.
• Liaise with internal departments to progress Process Validation studies.
• Take part in Risk Assessments to determine the validation approach for validation projects.
• To generate, execute and peer review appropriate documentation to enable life cycle validation of: Manufacturing and Primary packaging processes: Process Validation Protocol, Process Validation Report, Continued Process Verification Protocol, Continued Process Verification Report, Third Party validation documentation and studies, as appropriate.
• Support execution of Process Validation studies.
• Use of a Continuous Improvement ethos to standardise and optimise Process Validation at PCI.
• Ensure all activities undertaken are in accordance with statutory, regulatory and company EHS and cGMP standards, procedures, and systems.
• Be a strong team player with open communication style with the ability to direct others and deliver clear instruction, including internal personnel, suppliers, and contractors.

Role requirements:

• Experience in manufacturing and packaging of pharmaceuticals or medical devices, ideally pharmaceutical manufacturing of oral solid dose, oral liquid dose, topical ointments, and creams.
• Proficient user of software packages including MS Excel, Word, Powerpoint and Visio, together with a high level of computer literacy.
• Proficient in the use of MS Project and Statistical software (JMP/Minitab). People Management experience.
• Educated to BTEC HND or degree level in a technical or science subject or a minimum of five years previous experience working in a similar technical role.