Validations Team Leader

Based within the QA Validation Department, the successful candidate will assist the Validation Manager and Head of Validations with the supervision, coordination and execution of equipment, facility, utility and computerised system validation studies, whilst ensuring activities are conducted in full compliance with all health and safety, cGMP and regulatory requirements.

Main Activities / Tasks
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The role will involve:

• Development and oversight of the scheduling and execution of qualification activities, including the generation of validation master plans covering these activities.
• Coordination and supervision of Validation Analysts to ensure that all equipment, facility, utility and computerised system validation studies are scheduled and conducted within defined timeframes and schedules. 
• Training and mentoring of Validation Analysts in line with skills progression framework.
• Technical review and ensuring completion of deviations, change control actions, OOS investigations and CAPAs associated with Validation Activities.
• Communicating the status of validation projects and activities as required.
• Contribute to project teams for the introduction of new or changes to existing processes involving Qualification activities.
• Compilation and review of Standard Operation Procedures and other technical documentation in line with current GMP and regulatory requirements
• Promoting and supporting necessary changes within the department, as well as the department’s simplification & efficiency programme.
• Participate in customer 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:

• Applicants must therefore demonstrate the following essential criteria on their application form in order to be considered:
• Third level qualification in a science related discipline or a minimum of 5 years relevant industry experience.
• Excellent written and oral communication skills as demonstrated in the application form and at interview.
• Have a ‘Hands On’ approach to working within a fast paced work environment.
• Proven ability to organise, plan and prioritize multiple concurrent tasks whilst maintaining a high level of accuracy in all work produced along with a proven ability to meet deadlines.

Desirable Criteria:

• Due to the nature of the role preference will be given to applicants demonstrating the following desirable criteria:
• Knowledge of Pharmaceutical product manufacturing and filling processes

Duration: Full Time, Permanent

Location: Newry

Additional Information:

• This role will be based in a site that produces and handles penicillin, and as such, this role would not be suitable for those that have a penicillin allergy.
• 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.

Benefits:

• Free Life Assurance
• Company Pension Scheme
• Healthcare cash plan
• 32 days annual leave
• Wedding Leave
• Company Sick Pay
• Employee well-being initiatives
• Employee Assistance Programme
• On-site free parking
• Canteen Facilities
• Employee Perks scheme
• Employee Recognition scheme
• Career development opportunities