The Opportunity:

In this position you will be responsible for preparing documents, receipt and log of sample, update trend, coordinate with outside service provider using the correct procedures in order to comply with GMP, Health and Safety, SOPs and environment and regulatory requirements while ensuring we meet our customer’s needs.

In this position, you will report to the Asisstant QC Manager.

KEY RESPONSIBILITIES:

· To receive and log samples from Production and Warehouse.

· To update reference standards and working standards data base

· To send samples to contract Labs for testing

· Support QC with procurement and receipt of reagents, chemicals, solvents, reference standards etc.

· Issue QC Data sheets for batch testing

· Support the laboratory testing schedule in order to achieve an efficient QC system and Customer Service level of >95%.

· Maintain all laboratory logbooks, notebooks and associated documentation to GLP standard.

· Liaise with Managers/Team Leaders/Supervisors and Production to ensure adherence to key deliverables and meet KPIs.

· Ensure timely feedback to all queries as appropriate.

· Escalate to Managers/Team Leaders/Supervisors any discrepancies, deviations or non-conformances in testing or work practices.

· Ability to problem solve and follow up on Corrective Actions

· Dispatch samples for external testing when required

· Participate in internal/external audits

· Liaise with external suppliers/vendors in relation to QC consumables.

· Ensure existing quality procedures are followed and where appropriate suggestions/change control forms are prepared to ensure continuous improvement of the quality system.

· Adhere to any internal laboratory rota task.

· Maintain good housekeeping and hygiene within the QC laboratory areas.

· Adhere to laboratory safety measures at all times highlighting areas of improvement.

· Ensure the QC laboratory is kept clean and tidy and that GMP/GLP standards are adhered to at all times.

· Ensure records pertaining to QC are kept up to date and filed properly.

· Any other duties assigned by the QC Manager/Team Leader/Supervisor

COMPETENCIES:

· Ability to build relationships and collaborate efficiently with others.

· Good communication skills, both verbal and written

· Maintains the highest standards of ethical behaviour. Escalates issues appropriately

· Flexible and shows willingness to learn and develop technical and soft skills

· Takes a methodical, systematic and structured approach to organising work

· Positive and proactive person who is energized by having great responsibility.

The above in not intended to be construed as an exhaustive list of all responsibilities, duties and skill required for this role and may be subject to change.

QUALIFICATIONS:

· 3rd level qualification – Bachelor’s degree in science-based discipline or equivalent or extensive experience in Laboratory Duties

· Strong computer skills in Microsoft Office

· Experience working within the Pharmaceutical cGLP environment, with knowledge of EU GMP and US FDA guidelines

PHYSICAL DEMANDS: Health & Safety requirements (eg. Manual Handling Training)

• 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.
• To cooperate with Chanelle Pharma or any of its representatives that will enable the company to comply with the relevant health and safety statutory provisions.
• Adheres to safety regulations by ensuring correct usage of PPE in the lab area.
• 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.
• Keeps 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
  • Manual Handling training,
  • Glove removal and disposal training,
  • Working with chemicals
  • Disposal of waste
  • Working on PC

WORK ENVIRONMENT: (e.g. Office, Production)

• Laboratory