R&D Compliance Lead

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 standardsDisplay technical competency and a full understanding of methods and equipment related to HPLC, IR, UV, dissolution, and physical testingCalibrate and maintain laboratory equipment and liaise with service engineers as requiredCheck analytical results and approve raw materials, finished products, and packaging materialsEnsure data integrity is maintained in the R&D laboratories and procedures are followedMaintain and follow all relevant Standard Operating Procedures (SOPs)Review and approve all pilot batch documentation including Work Orders and Process Validation ProtocolsReview and approve stability protocols for R&D pilot batches in line with ICH/VICH GuidelinesEnsure timely feedback of all queries as appropriateBring to the notice of the team leader/supervisor any discrepancies, deviations, or non-conformances in testing or work practiceComplete OOS investigations and follow up on corrective actionsAmend lab procedures (SOPs, FPPs, ECPs, etc.)
as and when appropriateParticipate in internal/external audits of the R&D functionEnsure 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 improvedEncourage and maintain good housekeeping and hygiene within the laboratoryProactively create and encourage a safe working environment, adhering to laboratory safety measures at all timesLead by example, ensuring that your work area is kept tidy and that GLP/GMP standards are adhered to at all timesEnsure records pertaining to R&D are kept up to date and filed properlyProvide support as required to the R&D Manager/Head of R&DAny other duties as assigned by the R&D Manager/Head of R&DCompetencies: Establish strong working relationships with others, building team rapport, and creating a cohesive team environmentDisplay a positive outlook with strong coaching skills, maintaining interest at all timesTake a methodical, systematic, and structured approach to organizing workMake effective and consistent decisions in a timely mannerTake personal responsibility for making a decision and taking action within their own areaEscalate issues appropriatelyTake action to correct poor performance by being fair and consistent in approachDisplay flexibility, willingness to succeed and goes the extra mileQualifications: 3rd level qualificationDegree in Science Discipline or equivalentBiology and/or chemistry courses/background requiredPractical knowledge of analytical techniquesStrong verbal and written communication skillsStrong computer skills in MS OfficeIf 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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