QC Compliance Officer

Galway

BASIC SUMMARY:

  • To provide technical expertise to assist in the analytical testing on finished product & raw materials using the correct procedures in order to comply with GMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring we meet our customer’s needs.
  • To provide support as required to the QC laboratory supervisor

 

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.
  • To support the laboratory testing schedule in order to achieve an efficient QC system and Customer Service level of >95%.
  • Maintain and follow all relevant Standard Operating Procedures (SOP’s).
  • Timely Review and maintain all laboratory logbooks, notebooks & associated documentation to GLP.
  • Ensure timely feedback of all queries as appropriate.
  • To bring to the notice of the team leader/supervisor any discrepancies, deviations or non conformances 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 QC function.
  • Ensuring that existing 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 QC are all kept up to date and filed properly.
  • Displays key behaviours such as:
  • 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, 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
  • Any other duties as assigned by the QC team leader/supervisor or manager.
  • If decided appropriate it may be decided to amend / update any of the above responsibilities.

 

 

QUALIFICATIONS:

  • Degree in Science Discipline or equivalent.
  • Biology and/or chemistry courses / background required.
  • Practical knowledge of analytical techniques.
  • Strong computer skills.
  • Ability to manage time to meet demanding deadlines, multiple and shifting priorities.
  • Attention to detail.
  • Ability to work without intense supervision.
  • Team attitude with ability to work well with others.
  • High ethical business standards
  • Self-motivated
  • Strong verbal and written communication skills

QC Compliance Officer

Galway