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R&D Compliance Lead

4 weeks ago

Galway, Galway, Ireland Pharmaceuticalcarrier Full time

With a strong presence in 96 countries, we are committed to providing innovative and effective solutions to meet the needs of our customers. Our Research & Development team is seeking a dynamic and passionate individual to join us as an R&D Compliance Lead.

Job Summary: As the R&D Compliance Lead, you will be responsible for ensuring that all laboratory procedures and practices are compliant with pharmacopoeia's, regulations, and industry standards. You will oversee the calibration and maintenance of laboratory equipment, ensure data integrity is maintained, and participate in internal and external audits of the R&D function. Additionally, you will maintain and follow all relevant Standard Operating Procedures (SOPs) and keep records up to date.

Key Responsibilities:

  1. Generate, review, and approve existing methods with reference to pharmacopoeia's, specifications, regulations, and industry standards
  2. Display technical competency and a full understanding of methods and equipment related to HPLC, IR, UV, dissolution, and physical testing
  3. Calibrate and maintain laboratory equipment and liaise with service engineers as required
  4. Check analytical results and approve raw materials, finished products, and packaging materials
  5. Ensure data integrity is maintained in the R&D laboratories and procedures are followed
  6. Maintain and follow all relevant Standard Operating Procedures (SOPs)
  7. Review and approve all pilot batch documentation including Work Orders and Process Validation Protocols
  8. Review and approve stability protocols for R&D pilot batches in line with ICH/VICH Guidelines
  9. Ensure timely feedback of all queries as appropriate
  10. Bring to the notice of the team leader/supervisor any discrepancies, deviations, or non-conformances in testing or work practice
  11. Complete OOS investigations and follow up on corrective actions
  12. Amend lab procedures (SOPs, FPPs, ECPs, etc.) as and when appropriate
  13. Participate in internal/external audits of the R&D function
  14. Ensure that existing R&D and Quality procedures are followed in all areas and where appropriate suggestions/change control forms prepared so that the quality system can be improved
  15. Encourage and maintain good housekeeping and hygiene within the laboratory
  16. Proactively create and encourage a safe working environment, adhering to laboratory safety measures at all times
  17. Lead by example, ensuring that your work area is kept tidy and that GLP/GMP standards are adhered to at all times
  18. Ensure records pertaining to R&D are kept up to date and filed properly
  19. Provide support as required to the R&D Manager/Head of R&D
  20. Any other duties as assigned by the R&D Manager/Head of R&D

Competencies:

  1. Establish strong working relationships with others, building team rapport, and creating a cohesive team environment
  2. Display a positive outlook with strong coaching skills, maintaining interest at all times
  3. Take a methodical, systematic, and structured approach to organizing work
  4. Make effective and consistent decisions in a timely manner
  5. Take personal responsibility for making a decision and taking action within their own area
  6. Escalate issues appropriately
  7. Take action to correct poor performance by being fair and consistent in approach
  8. Display flexibility, willingness to succeed and goes the extra mile

Qualifications:

  1. 3rd level qualification
  2. Degree in Science Discipline or equivalent
  3. Biology and/or chemistry courses/background required
  4. Practical knowledge of analytical techniques
  5. Strong verbal and written communication skills
  6. Strong computer skills in MS Office

If you are interested in this exciting opportunity to be part of a dynamic team, please submit your resume and cover letter to us. We are an equal opportunity employer and welcome applications from all qualified individuals.

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