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:
Generate, review, and approve existing methods with reference to pharmacopoeia's, specifications, regulations, and industry standards
Display technical competency and a full understanding of methods and equipment related to HPLC, IR, UV, dissolution, and physical testing
Calibrate and maintain laboratory equipment and liaise with service engineers as required
Check analytical results and approve raw materials, finished products, and packaging materials
Ensure data integrity is maintained in the R&D laboratories and procedures are followed
Maintain and follow all relevant Standard Operating Procedures (SOPs)
Review and approve all pilot batch documentation including Work Orders and Process Validation Protocols
Review and approve stability protocols for R&D pilot batches in line with ICH/VICH Guidelines
Ensure timely feedback of all queries as appropriate
Bring to the notice of the team leader/supervisor any discrepancies, deviations, or non-conformances in testing or work practice
Complete OOS investigations and follow up on corrective actions
Amend lab procedures (SOPs, FPPs, ECPs, etc.) as and when appropriate
Participate in internal/external audits of the R&D function
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
Encourage and maintain good housekeeping and hygiene within the laboratory
Proactively create and encourage a safe working environment, adhering to laboratory safety measures at all times
Lead by example, ensuring that your work area is kept tidy and that GLP/GMP standards are adhered to at all times
Ensure records pertaining to R&D are kept up to date and filed properly
Provide support as required to the R&D Manager/Head of R&D
Any other duties as assigned by the R&D Manager/Head of R&D
Competencies:
Establish strong working relationships with others, building team rapport, and creating a cohesive team environment
Display a positive outlook with strong coaching skills, maintaining interest at all times
Take a methodical, systematic, and structured approach to organizing work
Make effective and consistent decisions in a timely manner
Take personal responsibility for making a decision and taking action within their own area
Escalate issues appropriately
Take action to correct poor performance by being fair and consistent in approach
Display flexibility, willingness to succeed and goes the extra mile
Qualifications:
3rd level qualification
Degree in Science Discipline or equivalent
Biology and/or chemistry courses/background required
Practical knowledge of analytical techniques
Strong verbal and written communication skills
Strong computer skills in MS Office
We are an equal opportunity employer and welcome applications from all qualified individuals.
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