Quality Operations Laboratory Project Specialist

Co. Dublin, Grange Castle

Job Purpose:

To 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.

Reporting Structure:

Manager, Quality Operations Projects

⇧

Quality Operations Laboratory Project Specialist

Job Responsibilities:

· Lead and project manage multiple stakeholders; attend all relevant project and equipment related meetings to give updates on project status at all required forums.

· Maintain project schedules and manage to conclusion throughout capital and validation lifecycle. Provide completion reports.

· Manage pre-requisite tasks to secure investment including liaising with stakeholders, vendors, Site Digital, QC Digital, QC Data Integrity, QC Equipment Validation, Quality Assurance Validation, Electrical Engineering and Site Engineering including cybersecurity assessments.

· Drive projects to completion by working collaboratively with all parties to implement project deliverables to project plans, on time, on schedule and on budget.

· 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 Quality Project Manager and 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 Quality Project Manager 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 qualifications of new equipment.

· Write the User Requirement Specification (URS) document for each piece of equipment or project required.

· Create packs in digital execution systems for review and approval.

· Write and raise change controls in Quality systems as required.

· Present change controls at the change control forum for endorsement.

Education/Experience

· To be successful in this role the following are prerequisites to application:

· 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/eQMS.

· Experience with paperless digital systems e.g. Kneat; is preferable but not essential.

· Knowledge of validation and computer system lifecycles is an advantage.

· Demonstrated ability to successfully collaborate, influence and lead in a matrix organization

· Excellent communication and interpersonal skills

· Proven record in demonstrating agility and capability to work in a fast-paced environment.

· Advantage to have previous project management experience but not essential.

· Experience of involvement in technical issue resolution, in a multidisciplinary environment

· Experience with trouble shooting Quality Control instrumentation.