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 to 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.

We are looking for Production Operators to join our team to work across several production areas including dispensing, mixing and tabletting, you will get the opportunity to build varied production experience in a GMP setting. Ideally having experience in a regulated manufacturing environment you will be able to contribute your knowledge to the team in order to support our continued growth.

As a production operator within our Production team, you will be involved in a wide range of manufacturing activities for solid oral dose veterinary pharmaceuticals.

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.

Validation Manager – Yatton, Somerset