Validation Team Leader

Job Overview

Norbrook are seeking a highly motivated Validation Team Leader to join our team, responsible for leading and coordinating sterilisation and aseptic processing validation activities within a regulated manufacturing environment ensuring all studies are conducted in full compliance with all health and safety, cGMP and regulatory requirements.

Main Activities/Tasks

• Scheduling, coordination and supervision of Validation Analysts to ensure that all sterilisation and aseptic processing validation studies are scheduled and conducted within defined timeframes and in-line with the production schedule. 
• Training and mentoring of Validation Analysts in line with skills progression framework.
• Conducting meetings with the team of Validation Analysts to ensure the relevant validation activities are scheduled, prioritised and completed, and that company/departmental communications are relayed within the team.
• Drive completion of deviations, change control actions, OOS investigations and CAPAs associated with Validation Activities.
• Communicate status of validation projects to ensure effective cross-functional collaboration.
• Participation in sterilisation, depyrogenation and Media Fill simulation trials in aseptic manufacturing facilities, in accordance with relevant protocols and standard operating procedures.
• Recording, verifying and reporting results and other relevant information for the validation activities performed.
• Preparation, review and approval of Validation Protocols and Reports for validation of sterilisation, depyrogenation and Media Fill studies.
• Perform laboratory duties relating to Validation studies or as required by other Validation activities.
• Preparation of Standard Operation Procedures, Validation Master Plans and other technical documentation in line with current GMP and regulatory requirements.
• Participate in internal, external and regulatory audits/inspections.
• Ensure that Health and Safety practices and procedures are followed in the incumbent's area of responsibility.
• Any other duties as deemed necessary by management.

Essential Criteria:

• Proven experience in validation within aseptic manufacturing or sterile environments
• Strong knowledge of cGMP and regulatory requirements
• Experience with sterilisation, depyrogenation, and media fill processes
• Demonstrated leadership or supervisory experience
• Excellent organisational, communication, and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment

Duration: Permanent

Location: Newry

Additional Information:

• Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
• We regret that applications received after the closing date and time will not be accepted.
• We are unable to sponsor or take over sponsorship of a Visa at this time.
• This role is based on a site that produces penicillin and as such, would not be suitable for those with a penicillin allergy.

Contact: recruitment@norbrook.co.uk

Norbook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community.