Position Overview You will have overall responsibility for site Qualification and Validation activities. You will be required to define, execute and report on all validation activities. You will be responsible for carrying out qualification lifecycle studies (from URS through to PQ) to ensure optimal performance and output.
Location Yatton, Somerset
Company Overview Pets Choice (Bob Martin) manufactures a range of non-prescription veterinary medicinal products at its purpose-built site in Yatton, Somerset. Our products include a range of liquid spot-on treatments, shampoos, and solid dosage tablets for both condition treatments and animal health. The site is regulated by the Veterinary Medicines Board and complies with cGMP. Having established some exciting NPD development, the business has invested in a new aerosol line to further support its growth and add to the product portfolio. This is an exciting time to join the business as we have multiple projects being worked on and have invested heavily into the facility to support the delivery of these.
Main Responsibilities: - Responsibility for defining and maintaining the site validation master plan (VMP) and cleaning validation master plan (CVMP).
- Define, execute and report qualification and validation studies in order to establish and maintain the qualified and validated status of a range of facilities, utilities, equipment, processes, and computer systems in accordance with regulatory requirements and industry standards.
- Establish a risk-based validation approach using Quality Risk management principles to ensure that risks relating to validation are appropriately identified and documented.
- Investigation and resolution of non-conformances encountered during requalification, revalidation, and periodic review activities.
- Acting as Subject Matter Expert for validation during Regulatory and customer inspections.
Key attributes and skills: Essential: - Prior experience in a Pharmaceutical/GMP environment
- Good understanding of Qualification & Validation lifecycles
- Up-to-date knowledge of current regulatory requirements and industry standards associated with Validation activities
- Experienced in the execution of validation and qualification activities, including but not limited to URS, DQ, FAT, SAT, IQ, OQ, PQ, etc.
- Competent in the generation and review of technical documentation
- Understanding of Quality Risk Management principles and tools and their application throughout a risk-based qualification lifecycle.
Desirable: - Previous experience managing a Validation team.
- Experience of cleaning validation and computer system validation.