R&D Mechanical Test Lab Manager
|Job Title:||R&D Mechanical Test Lab Manager|
|Contact Name:||Larry O’Leary|
|Job Published:||7 months ago|
Our client, a blue-chip multinational healthcare manufacturer based in Galway, now seeks an R&D Mechanical Test Lab Manager who will manage day to day lab activities ensuring that testing of finished products, non-conforming products and associated materials is carried out in accordance with GLP and cGMP.
The successful candidate will be responsible for ensuring that the laboratory and its users adhere to Corporate and Regulatory requirements in the completion of testing, complaints investigation, technical investigation, test method optimization, test method development and test method transfers. Budgetary management experience is preferred.
Person-fit: a collaborative, organised, customer-focused professional; comfortable in a high-pressure role with responsibility for key infrastructure and technical staff; where a focus on quality data output and compliance is essential.
Responsibilities of R&D Mechanical Test Lab Manager:
Ensures that adequate resources (i.e. equipment, staff, consumables, facilities, etc.) are maintained to meet the department and company goals.
Implements policies and procedures to maintain compliance to standards and quality systems.
Manages method improvement activities, develops new test methods, and transfers methods into and out of the lab.
Provides technical oversight and leadership to employees who are responsible for performing laboratory functions.
Develops direct reports, and conducting formal written and verbal performance reviews.
Responsible for controlling access of all persons entering the lab.
Works closely with product development teams to develop test protocols.
Manages the scheduling, prioritization and completion of test plans.
Creates standardised reporting systems to communicate results to customers.
Ensures the timely review, compilation, interpretation and communication of results.
Final review and approval of laboratory results, protocols, reports, SOPs, etc.
Evaluates requests for non-routine and unplanned testing and facilitates these requests as needed.
Participates in cross functional teams to perform troubleshooting on new products/process problems as related to test method, design, material or process.
Ensures constant vigilance in the laboratory for non-conforming events and develops a culture of transparency, rapid evaluation and escalation to the appropriate level for such events.
Leads laboratory investigations.
Manages the purchase , installation and qualification of test equipment.
Ensures test equipment is maintained and calibrated to appropriate levels.
Serves as a representative for the department in all internal / external Audits as functional expert.
Maintains and enhances cross-functional and cross-site team relationships.
Requirements for R&D Mechanical Test Lab Manager:
Honours Bachelor's Degree in Scientific, Engineering or similar technical discipline (Level 8 is required).
Additional Masters or PhD would be ideal.
8+ years' experience in GMP regulated environment.
2+ year's Lab Management / Supervisory / Team Lead experience is required, in mechanical test environment.
Strong technical problem solving and troubleshooting skills.
Test Method development, test method validation and test method transfer experience.
Excellent interpersonal and communication skills with good leadership abilities.
Excellent analytical and problem solving skills.
Proven track record of working in a fast paced environment with strong technical capabilities
Please contact Larry on +353 1-2302400 / firstname.lastname@example.org
The RFT Group, Biopharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie / www.meddevicejobs.ie
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Key Words; FDA, GMP, R&D, Mechanical Testing, Lab Manager, Test Method Development, Test Method Validation, Test Method Transfer, Medical Devices, Galway, Clare, Connaught, Nationwide, Ireland.
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