R&D Compliance Lead

Galway

About Chanelle Pharma:

Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.

Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions. 

The Opportunity:

This is an opportunity to be part of a dynamic team within the Research & Development Team and feeding into the Quality Control function.  We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.

KEY RESPONSIBILITIES:

  • Generation, review & approval of existing methods with reference to pharmacopoeia’s, specifications, regulations and industry standards.
  • Displays technical competency and full understanding of methods and equipment relating to the following areas: HPLC, IR, UV, dissolution & physical testing.
  • Calibration and maintenance of laboratory equipment as per calibration procedures & liaison with service engineers as required.
  • Checking analytical results and approval of raw materials, finished product & packaging materials.
  • Ensure data integrity maintained in the R&D laboratories and procedures has been followed.
  • Maintain and follow all relevant Standard Operating Procedures (SOP’s).
  • Timely Review and maintain all laboratory logbooks, notebooks & associated documentation to GLP.
  • Review and approval of all pilot batch documentation including Work Orders and Process Validation Protocols.
  • Review and approval of stability protocols for R&D pilot batches in line with ICH/VICH Guidelines.
  • Ensure timely feedback of all queries as appropriate.
  • To bring to the notice of the team leader/supervisor any discrepancies, deviations or nonconformances in testing or work practice.
  • To complete OOS investigations and follow up on corrective actions.
  • Amendment of lab procedures (SOP’s, FPP’s, ECPs etc) as and when appropriate.
  • Participating in internal/external audits of the R&D function.
  • Ensuring that existing R&D and Quality procedures are followed in all areas and where appropriate suggestions/change control forms prepared such that the quality system can be improved.
  • To encourage and maintain good housekeeping and hygiene within the laboratory.
  • To 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 R&D are all kept up to date and filed properly.
  • To 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:

    • Establishes strong working relationships with others, building team rapport and creating a cohesive team environment.
    • Displays a positive outlook with strong coaching skills, maintaining interest at all times.
    • Takes a methodical, systematic and structured approach to organising work.
    • Makes effective and consistent decisions in a timely manner.
    • Takes personal responsibility for making a decision and taking action within their own area.
    • Escalates issues appropriately.
    • Takes action to correct poor performance by being fair and consistent in approach.
    • Displays flexibility, willingness to succeed and goes the extra mile.

     

    The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.

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

R&D Compliance Lead

Reference No: J0249
Galway