The purpose of this position is to establish and maintain the validation of systems, processes, facilities, and equipment at the required standard within an organization. This must be carried out in accordance with legal requirements, particularly pharmaceutical regulations and GMP guidelines, while working with quality representatives to develop appropriate validation strategies where necessary.
There are several ongoing projects where you will oversee the implementation of new products on the line and new sensors on machines.
What you do
- Perform internal audits and support external audits (internal, customer, and notified body audits) related to validation activities.
- Develop, implement, and maintain validation studies in collaboration with Operations, Supply Chain, Technical Services, and Quality Assurance.
- Prepare and maintain documentation for all validation activities and validation results.
- Contribute to the continuous improvement and optimization of personnel, processes, systems, and procedures.
- Develop and maintain procedures related to validation activities.
- Assess validation requirements resulting from proposed changes to systems, processes, facilities, or equipment.
- Ensure validation activities are initiated and completed in a timely manner.
- Ensure all validation activities comply with current international validation regulations and Good Manufacturing Practice (GMP) requirements.
- Ensure implemented changes do not negatively affect the validation status of systems, processes, facilities, or equipment.
What they ask
- Strong Equipment Validation experience (30%) and documentation (70%).
- Good understanding of GMP guidelines, pharmaceutical regulations, microbiology, hygiene, and related quality requirements (can be a similar industry with strict regulations).
- Experience working with quality systems, procedures, and training programs.
- Proficient in Microsoft Office.
- Experience writing technical reports.
Profile
- Motivated and proactive personality.
- Leadership skills.
- Strong sense of ownership and responsibility.
- Able to organize work independently, prioritize effectively, and work well as part of a team.
- Goal-oriented.
- Strong analytical and open-minded approach.
How to apply
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