DUTIES AND RESPONSIBILITIES:
- The execution and completion of process, systems and equipment validations and revalidations in accordance with Validation Master Plans, schedules and Company policy.
- Prepare, execute and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
- As assigned, participate in cross functional teams to establish validation strategies and objectives to support process and equipment changes.
- Ensure all departments understand and comply with the requirements of cGMP as applied to the validation program for the Membrane plant. As needed, assist in providing related training and support.
- Provide guidance and support to all departments/staff as needed regarding related issues, ensuring compliance, as applicable, with 21 CFR , ISO13485 and all other Quality Standards, Validation Regulations and Guidance Documents.
- Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents. Provide related updates to department management according to the latest EU/U.S and ICH requirements.
- Ensure compliance with Software and Hardware Validation regulatory requirements, 21 CFR part 11, GAMP and other guidance documents, as appropriate to the business needs.
- Monitor the progress of validation projects on a daily/weekly basis ensuring that there is continuous drive/focus on meeting schedules.
- Participate in the review of validation practices for the membrane plant; monitor trends, and initiate improvement opportunities. Escalate any out-of-norm matters to department management as applicable.
- Any other responsibility as set out by Supervisor/ Manager
- A qualification in appropriate Quality Assurance/Science discipline and at least 5 years relevant experience in a regulated environment
- Good regulatory knowledge
- Good verbal and written communication skills, including the ability to conduct verbal presentations.
- Demonstrated success working in a team environment.
- Ability to work under pressure to meet scheduled deadlines
- Proven technical protocol and report writing skills
- Ability to design and implement validation programs