Description
Global generic and speciality pharmaceutical company are seeking a Senior Validation engineer to join their team.- Maintaining Site Validation Master Plan, Validation Plans (C&Q Plan, Cleaning Validation Plan, Computer Systems Validation Plan, Process Validation Plan) and Validation SOPs, and ensuring compliance of these plans and procedures for Validation.
- Ensuring site Qualifications are executed in adherence with Site Validation Master Plan, Validation Plans & SOPs, and presenting executed Qualifications during internal and external audits.
- Responsible for Site Computer System Validation activities
- Responsible for developing and executing Validation strategies (Validation Plans, Validation Protocols, Validation Reports) for key site Equipment, Systems and Utilities, in line with current regulatory requirements, corporate policies and site procedures.
- Ensuring that a continuous state of Validation is maintained for site Equipment, Systems, Utilities and Processes, including providing Validation input for site Change Controls
- Training, mentoring and management of Validation personnel
- Responsible for leading site Periodic Review and Revalidation activities for Equipment, Systems and Utilities.
- Drafting and executing site Process Validation protocols
Qualifications
- 3rd level qualification in a Science/Engineering or related discipline.
- A minimum of five years' experience in a similar role.
- Specific experience in CSV is required
- Good knowledge of manufacturing processes is required.
- Knowledge of process validation would be a distinct advantage.
- Good verbal and written communication skills
- Excellent trouble-shooting and problem solving skills
- Good computer skills (MS Word, Excel and PowerPoint)
Please apply below with an up to date CV and I will call you with more information on the company and the role.