QA Validation Specialist

3 weeks ago

clare claremorrisswinford municipal district ireland Meiragtx Ireland DAC Full time

Your mission
To provide QA Validation and Qualification technical support and oversight for the manufacture and supply of Gene Therapy medicinal products. The QA Validation Specialist will play a key role as part of the MGTX Ireland Project team providing hands-on QA technical support and oversight to Qualification and Validation activities of the Manufacturing facility and QC Laboratories, ensuring that processes and equipment are appropriately validated and qualified in accordance with applicable Irish, EU and FDA regulations and the MeiraGTx QMS.

Job DescriptionMajor Activities
  1. Preparation and Maintenance of the Irish site validation plan for MeiraGTx.
  2. Maintenance and archiving of Validation/Qualification documentation.
  3. Interface with other departments such as Engineering, QC Laboratories, Operations, Supply Chain and Process Development to ensure that validation project plans are understood and adhered to.
  4. Clearly communicate and/or provide training in the required validation standard to both the MeiraGTx staff and contractors.
  5. Review and approve validation, qualification protocols and reports.
  6. Provide oversight to project-related Deviations.
  7. Maintain understanding of cGMP, Good Engineering Practices and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
  8. Support generation of Process and QC Equipment Installation, and Operational and Performance Qualifications, review and approve the Qualification protocols, discrepancies and reports for Quality.
  9. Interface with external consultants and partners as directed by QA Validation and Materials Supply Manager, suppliers and contractors to ensure successful process and equipment validation.
  10. Provide QA support to data integrity compliance activities across the site. Write or assist in writing of MeiraGTx Policies, SOPs, work instructions and forms for validation requirements and other quality systems as required.
  11. Support Regulatory Inspections and third party audits.
  12. Ensure own work complies with GxP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents.
  13. Ensure own training is undertaken in a timely and compliant manner before the task is undertaken.
Responsibilities
  1. Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
  2. Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
  3. Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state.
  4. Ensure validation of the processes and equipment meets applicable regulatory requirements for a new GMP Gene Therapy manufacturing facility.
  5. To effectively guide the implementation of the Site Validation Master Plan, working with the engineering, operations and QC teams to oversee the commissioning; qualification and validation of the manufacturing facility and supporting activities.
  6. Participate in risk assessments to develop process validation plans and protocols with Development, Operations and QC staff.
  7. Implement robust and 'fit for purpose' validation procedures ensuring the facility, equipment, and processes are validated, qualified and maintained to regulatory requirements.
  8. All responsibilities are performed in a timely manner, escalating any and all issues to senior management as and when they occur.
  9. Recommend improvement in validation management practices and documents.
Key Job Competencies
  1. The individual must have an established track record in delivering robust and regulatory compliant Validation Plans and Protocols.
  2. Extensive experience of GxP compliance requirements.
  3. Able to interact with other departments and personnel across the business both verbally and in writing, demonstrating good interpersonal skills.
  4. Can identify and escalate issues to line management, to ensure workload is prioritised, issues are highlighted to ensure business needs are met.
  5. Able to respond flexibly and adapt to the needs of the department/wider business, demonstrating good organisational and time management skills.
Background/Experience
  1. BSC in Science / Engineering
  2. Languages - English
  3. Strong Quality Assurance background working in a Pharmaceutical or Biotech Production environment within sterile manufacturing.
  4. Extensive experience with providing QA technical support and oversight to validation and qualification activities and with implementing the concepts, legislation, guidelines and requirements related to qualification and validation of sterile products, aseptic processes, equipment and systems, including Computer System Validation e.g. EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11 & CFR Part 11 and ICH Q9.
  5. Knowledge of cell culture-based manufacturing techniques and requirements and cellular and gene therapies.
  6. Experience in using risk assessment tools including FMEA.
  7. Ability to balance needs of the business with the needs of the Regulatory challenges.
  8. Proven ability to work successfully in an ambitious, deadline-driven environment and handle multiple tasks simultaneously.
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