Validation Co-Ordinator
Job Summary
SRG are seeking a proactive and detail-oriented Validation Co-ordinator to join our clients Validation department that specializes in the development and manufacture of active pharmaceutical ingredients for the pharmaceutical and biotechnology industries on a 6-month fixed-term basis. This role is critical in ensuring that validation activities across production and quality functions are executed effectively and in compliance with regulatory standards.
Job Title: Validation Co-ordinator
Contract Type: Fixed-Term Contract (6 Months)
Location: Edinburgh
Salary: £40,000 per annum (pro-rata)
Hours: 37.5 hours per week (Monday to Friday)
Start Date: Immediate
Key Responsibilities
* Liaise closely with Manufacturing, Development, and Quality departments to support validation activities.
* Develop strategies for individual validation studies in consultation with cross-functional teams, considering past experiences, company policies, and product-specific needs.
* Prepare and maintain Validation Master Plans.
* Coordinate validation plans in alignment with production schedules.
* Collate historical data and pre-validation manufacturing information to support protocol development.
* Author qualification and validation protocols and reports for both process and cleaning validation.
* Assist in equipment and software qualification, including execution and approval of non-critical deviations.
* Conduct periodic qualification reviews.
* Perform risk assessments related to validation activities, including change control evaluations.
Ideal Candidate Profile
* Experience in validation within pharmaceutical or manufacturing environments.
* Strong understanding of GMP and regulatory compliance.
* Excellent communication and coordination skills.
* Ability to work collaboratively across departments.
* Analytical mindset with attention to detail.