Job description
Closing date 18/12/2022
Job Responsibilities:
- Oversee the continued operation of QC Sample Management (QCSM) by means of a hands-on approach to laboratory operations.
- Lead the QC sample management team of analysts, coordinating daily operations and ensuring team members are trained in their job function and current revisions of relevant SOPs, to maintain a high-volume laboratory function within a diverse QC laboratory operation.
- Support the team in their application of local and corporate standards as well as EHS standards to ensure a fully compliant, effective and safe QC Support Operation at GC.
- Oversee the Managed Services that support the laboratories in keeping glassware, autoclave load, clean of equipment and other managed service tasks.
- Collaborate with customers both internal and external including but not limited to the Quality Control laboratories, operations, external support / network teams and NPI teams to ensure all QC process support requirements are delivered within committed lead times and any actions / activities are completed to high standards.
- Represent your QC function at product, technical and robustness team meetings and lead/drive all associated deliverables.
- Support the QC laboratory function inspection readiness programme ensuring a continuous inspection ready function at all times.
- Maintain laboratory in a state of audit readiness.
- Facilitate laboratory investigations and support associated product investigations.
- Troubleshoot laboratory methods and instrument problems.
- Support the preparation and review of respective QC APQR and periodic review reports.
- Contribute to the operations of the Quality Control Laboratories.
- Engage with continuous improvement, 5S and Standard Work to help ensure the team and processes operate efficiently.
Training
- Ensure that staff are trained and equipped to carry out required tasks.
- Train, motivate, and develop a competent team of analysts.
GMP/Safety
- Implement and adhere to appropriate levels of cGMP within the laboratory.
- Promote safety awareness and the established culture of IIF within the assigned work area.
Planning
- Ensure that the area is sufficiently resourced to meet Plan of Record requirements.
- Ensure that sample processing and analysis are conducted in a timely and compliant manner to meet batch disposition requirements.
Personnel
- Manage the training, motivation and development of an excellent team of Quality professionals within the laboratory function including:
- Development and approval of job descriptions for staff
- Development of training curricula
- Development of Goals and Objectives
- Coaching of direct reports.
- Performance appraisal of functional area personnel.
- Manage a career development program to recruit/retain laboratory staff as necessary.
Qualifications
Experience
- Previous supervisory experience in a biotech/pharmaceutical laboratory is preferred but not mandatory.
- B.Sc. degree in biological/chemical sciences, business, or other related technical degree or equivalent experience in regulated industry.
- A minimum of 6 years working experience in quality control in a laboratory environment.
- Proven expertise and technical competence
- Demonstrated ability to successfully collaborate, and influence in a matrix organization.
- Proven ability to recognize / communicate problems and required resolution in a positive and proactive manner.
- Excellent communication and interpersonal skills
- Proven record in demonstrating agility
- Experience of involvement in technical issue resolution, in a multidisciplinary environment
Work Location Assignment: On Premise
Additional Information
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In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
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Please note there is no relocation support available for this position
How to apply
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Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
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