Job description
Matrix Recruitment are currently recruiting for a QC Micro Specialist on behalf of our client based in Dublin.
Your New Role:
A great opportunity has arisen for a QC Microbiology Specialist. The QC Microbiology Specialist role is a critically important role to ensure efficient and effective compliance, qualification, and operation of the company Drug Substance facility.
Key Duties and Responsibilities:
What you need?
Your New Role:
A great opportunity has arisen for a QC Microbiology Specialist. The QC Microbiology Specialist role is a critically important role to ensure efficient and effective compliance, qualification, and operation of the company Drug Substance facility.
Key Duties and Responsibilities:
- Perform and support QC analytical activities including in-process, release and stability related testing.
- Provide day to day direction and scheduling to the QC analyst team.
- Responsible for the qualification, maintenance, and/or integration of the QC methods, in compliance with up-to-date data integrity, regulatory, and industry standards
- Responsible for driving a culture of Continuous Improvement.
- Ensure that cGMP standards are maintained at all times.
- Accountable for change control process and mechanisms required to maintain a state of continued compliance for the methods.
- Manage deviations, CAPAs and change controls.
- Author/review technical documents, standard operating procedures and actions for the performance of laboratory methods.
- Participate in risk assessments and implement and follow-up on corrective / preventative measures.
- Serve as an SME for regulatory and internal inspections and audits.
- Work cross-functionally to build and operate testing capability within the lab.
- Escalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality.
- The desire to continuously learn, improve and develop.
- Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations, and industry standards.
- Writing and updating SOPs.
- Ensure training is current for all job functions performed.
- Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.
What you need?
- 5 years industry experience with significant knowledge and experience working in a Microbiology Laboratory in a pharmaceutical company
- Bachelor's Degree Qualification (Science, Microbiology preferred)
- Experienced in testing as per the pharmacopeia’s
- Working knowledge of QC Digital Systems (eLogs, Electronic Lab Notebook, LIMS etc.)