- Our client, a globally renowned pharmaceutical company based in County Dublin have a fantastic opportunity for an experienced Quality Operations Laboratory Project Specialist.
- The successful candidate will ensure all relevant QC documentation associated with the purchasing, introduction qualification and decommissioning of laboratory equipment and projects are complete to a high standard within the required time frames to facilitate business continuity for the QC Laboratories.
- This is an 11-month contract role with strong possibility for extension.
Core Duties and Responsibilities:
- Attend all relevant project and equipment related meetings to give input on project status.
- Responsible for setting up new equipment in LIMS and EAMS.
- Assist with the coordination of the management of space within the QC labs with respect to equipment.
- Assist with the decommissioning process for equipment to ensure that equipment is decommissioned in a timely manner to maximize the space available to the labs for the introduction of new equipment.
- Work with Engineering to ensure that the Fixed Asset Register (FAR) is accurate and up to date, to include performing annual asset counts.
- Drive process efficiencies tracking and reporting on improvements including cost, productivity and waste/rework as it relates to the management of projects and introduction of laboratory equipment.
- Work with Engineering to ensure ready to use equipment tracker is accurate.
- Trouble shooting common Quality Control instrumentation.
- Write and generate PIRFs and Customer Requirement Documents (CRD’s) as necessary to allow Engineering to begin the purchasing process associated with each project or piece of equipment.
- Complete Regulatory Assessment forms to aid with the categorization of qualification of new equipment.
- Write the User Requirement Specification (URS) document for each piece of equipment or project required.
- Write and raise change controls in the QTS system as required. (in project phase = QO Projs)
- Present change controls at the change control forum for endorsement.
- Drive projects to completion by working collaboratively with all parties to implement project deliverables to project plans.
Minimum Qualifications and Experience:
- Hold a B.Sc. degree in biological, /chemical sciences, business, or other related technical degree or equivalent experience in a regulated industry.
- Preferable 2-4 years’ experience in quality control in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment.
- Proven documentation skills with ability to generate text and write a document in a clear and unambiguous way, ensuring all relevant detail is covered.
- Experience working with a documentation system e.g. PDOCs and an investigation/change control system e.g. QTS.
- Demonstrated ability to successfully collaborate, influence and lead in a matrix organisation
- Excellent communication and interpersonal skills
- Proven record in demonstrating agility
- Experience of involvement in technical issue resolution, in a multidisciplinary environment
- Experience with trouble shooting Quality Control instrumentation.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
GC North Valley Business Centre, Cork, T23 KC67, Ireland.
+353 21 2066178
Please note, we do not require agency assistance with this role.