Quality Operations Laboratory Project Specialist
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.
· Own multiple project schedules from initiation to closure, liaise with System Owners and attend all relevant project and equipment related meetings to give input on project status.
· Drive projects to completion by working collaboratively with all parties to implement project deliverables to project plans.
· Support the execution of QC instrument equipment throughout the initial validation lifecycle by liaising with Vendors, Calibration, Engineering, EHS, QA and QC partners
· Responsible for setting up new equipment in LIMS and EAMS.
· Own and participate in QO Project forums
· 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.
· Participate in cross functional teams as required to provide support on, and resolution of, QC instrument and equipment validation requirements.
· Participate in new initiatives such as the 5S, Standard Work, Data Integrity and IMEX programs as they arise.
· Participate in and drive the continuous improvement of all aspects of the group.
· Ensure compliance with cGMP, corporate standards / Pfizer Quality System (PQS), site policies / procedures, and regulatory requirements.
· Technical writing assignments including SOPs, trend reports, risk assessments, laboratory investigations, and change controls.
· To be successful in this role the following are prerequisites to application:
· You will be delivery focused and can build rapport with key stakeholders both internal and external.
· 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
· Proven track record in working with Quality related projects
· Excellent communication and interpersonal skills
· Proven record in demonstrating agility and working in a fast-paced environment
· Experience of involvement in technical issue resolution, in a multidisciplinary environment
· Experience with trouble shooting Quality Control instrumentation.
· Good working knowledge of IT systems and their interactions with laboratory instrumentation would be considered an advantage but not essential