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- Location: Northern Ireland
- Salary: Competitive Salary
- Job Type:Permanent
Posted about 1 month ago
- Sector: Scientific
- Contact: Loraine Ngwenya
- Contact Email: loraine.ngwenya@nextphaserecruitment.com
- Contact Phone: 01403216216
- Start Date: ASAP
An established pharmaceutical manufacturer is seeking a Validation Analyst to join its Validation Department, supporting qualification and validation activities across pharmaceutical manufacturing facilities.
Applicants must have the right to work in the UK. Visa sponsorship is not available.
Key Responsibilities
Prepare, review and maintain qualification and validation documentation, including validation protocols, reports, master plans and SOPs.
Coordinate and execute commissioning, qualification and validation activities across equipment, facilities and systems.
Manage project schedules, monitor progress and support the achievement of key project milestones.
Contribute to the development and improvement of validation and operational procedures.
Work closely with cross-functional teams on qualification and validation projects.
Represent the Validation function during technical discussions and project meetings.
Ensure commissioning and qualification activities are completed in accordance with GMP and industry regulations.
Perform periodic reviews of equipment and systems and support implementation of any required corrective actions.
Essential Requirements
Degree in a scientific, engineering or information technology discipline. Candidates with A-Level (or equivalent) qualifications and a minimum of 12 months' relevant industry experience will also be considered.
Working knowledge of Good Manufacturing Practice (GMP) requirements.
Strong written and verbal communication skills, including technical report writing.
Excellent planning and organisational abilities with the capacity to manage multiple priorities.
Strong analytical, data interpretation and problem-solving skills.
Desirable Experience
Knowledge of pharmaceutical manufacturing and filling processes.
Experience with equipment, facility or software qualification within a GMP-regulated environment.
Understanding of Computer System Validation (CSV), including GAMP 5 and 21 CFR Part 11 requirements.
Knowledge of software development, process control systems or building management systems.
Experience supporting process improvement or quality improvement initiatives.
