Manager - Quality Compliance - OSD Formulations - Pharma

We are looking for Quality compliance expert for a leading Pharma in OSD Formulation based in Europe.

Location : Ireland

BASIC SUMMARY:

1. 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.

2. To provide support as required to the QC laboratory supervisor

ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Generation, review & approval of existing methods with reference to pharmacopoeia, specifications, regulations and industry standards.

2. Displays technical competency and full understanding of methods and equipment relating to the following areas: HPLC, IR, UV, dissolution & physical testing.

3. Calibration and maintenance of laboratory equipment as per calibration procedures & liaison with service engineers as required.

4. Checking analytical results and approval of raw materials, finished product & packaging materials.

5. Maintain and follow all relevant Standard Operating Procedures (SOP's).

6. Timely Review and maintain all laboratory logbooks, notebooks & associated documentation to GLP.

7. Ensure timely feedback of all queries as appropriate.

8. To bring to the notice of the team leader/supervisor any discrepancies, deviations or non conformances in testing or work practice

9. 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.

10. Ensuring that existing quality procedures are followed in all areas and where appropriate suggestions/change control forms are prepared such that the quality system can be improved.

11. To encourage and maintain good housekeeping and hygiene within the laboratory

12. 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 behavior such as:

1. Establishes strong working relationships with others, building team rapport and creating a cohesive team environment.

2. 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

3. Takes personal responsibility for making a decision, taking action within their own area Escalates issues appropriately

4. Takes action to correct poor performance by being fair and consistent in approach Displays flexibility, willingness to succeed and goes the extra mile

PHYSICAL DEMANDS:

1. Health & Safety requirements (eg. Manual Handling Training)

2. To take reasonable care for their own safety, health and welfare at work and that of any other person that may be affected by their acts or omissions while at work.

3. To cooperate with the senior or any of its representatives that will enable the company to comply with the relevant health and safety statutory provisions.

4. Adheres to safety regulations by ensuring correct usage of PPE in the lab area

5. Reports to the supervisor or health and safety representative without unreasonable delay any defects in plant, equipment, place of work, system of work which might endanger safety, health or welfare of themselves or any employee, contractor or visitor to the company.

6. Keeps the work area safe, clean and tidy Not too intentionally or reckless interfere with or misuse any appliance, protective clothing, convenience, equipment or other means or thing provided.

Required training

1. Manual Handling training, Glove removal and disposal training, Working with chemicals, Disposal of waste