Senior QC Analyst/QC Instrumentation Specialist (HPLC/GC)
In this role, you will ensure all laboratory instrumentation and equipment is operating, maintained and serviced as per schedule ensuring that products manufactured are tested to specification on time and quality and safety goals are met.
- Ensure Laboratory Computerized Systems compliance with Data Integrity policies and regulatory requirements.
- Understand Regulations and business processes required to maintain Laboratory Data Integrity.
- Ensuring all lab equipment is calibrated, qualified and maintained, adhering to schedules.
- Preparation and Review of documentation, pre and post approvals.
- Liasing and working with external vendors.
- Management of the Maximo system for laboratory equipment.
- Sourcing of new equipment through the Change plan process.
- Ensuring Laboratory operational efficiency by participating in project teams assigned by the Quality Control Manager.
- Control and management of laboratory purchasing/VMI related to instruments and equipment.
- Working closely with the QC Laboratory to ensure activities are planned and executed safely and efficiently.
- Management of MEP in the QC Laboratory.
- Relevant 3rd level degree
- A minimum of three years experience in a regulated manufacturing industry.
- Experience in QC testing in an HPRA/FDA regulated laboratory
- Laboratory equipment maintenance experience is desirable
- Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
- Proven track record of project planning / maintainance planning.
- Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
- Requires a very high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
- Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
- Requires total commitment to quality and maintaining a high standard of work at all times.
- Demonstrates the highest levels of integrity and a strong work ethic at all times.
- Strong communication skills both verbal and written are required for the execution of this role.
- Strong interpersonal skills are required.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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