Lab Manager - Quality - Mentor Medical Systems B.V.-00000QJ3
Omschrijving
Department:
Quality – Inspection & Testing Manager
Responsibilities & Accountabilities:
Under the direction of the Plant QA Manager and with the objective of maintaining high quality standards of the product manufacturing process and compliance with regulatory requirements, administers Quality Assurance laboratory support to the Quality Operations, and directly supervises Laboratory Supervisor, Laboratory Engineers in day to day activities supporting Breast Implant Business Unit has adequate laboratory support, test result reporting, test method validation, documentation review, and support projects, process and new product introductions or upgrading of existing processes and products and subsequent qualifications.
1. Leading, budgeting and resourcing a microbiology, analytical, incoming goods laboratory group. Directs and administers the activities of Lab supervisors, Lab Engineers and Lab technicians.
2. Carries out leading responsibilities in accordance with the organization’s policies and applicable laws including regarding health and safety.
3. Evaluates and recommends staffing requirements to ensure maximum utilization of personnel to fulfill department objectives.
4. Evaluates, recommends and approves expenses requirements to ensure maximum utilization of laboratory supplies to fulfill department objectives.
5. Approves purchases and expense reports submitted by direct reports.
6. Ensures that the quality and testing aspects for new processes, products and or upgrading of existing processes and products and subsequent PQ’s and PPQ’s are met.
7. Ensures that the testing at external supplier aspects for base business continuation, new processes, products and or upgrading of existing processes and products and subsequent PQ’s and PPQ’s are met.
8. Supports/Initiates investigations for non-conformances and OOSses.
9. Supports Operations in evaluation and implementation of actions plans to eliminate root causes of non-conformances.
10. Ensures incoming goods receipt, sampling and testing is performed supporting Operations Base Business Execution.
11. Ensures analytical, in process and finished device testing is performed supporting Operations Base Business Execution.
12. Ensures environmental and microbiology testing is performed supporting Operations Base Business Execution.
13. Ensures the coordination of test method, laboratory equipment validation (IQ/OQ/PQ) and acts as validation approver for Operations Validations.
14. Supports internal audit programs
15. Initiating and implementation of corrective and preventive action and quality data trending for CAPA review board evaluation.
16. SME during projects, regulatory, MDD and notified body audits/inspections.
17. Initiating and approval of labs and supplier quality related Non Conformances.
18. Promotes the use of Process Excellence tools to enhance analytical thinking and problem solving techniques.
19. Provides testing support to plant wide initiatives such as implementation of new initiatives safety, environmental and Quality related initiatives.
20. Supports on-going continuing efforts and projects to improve our manufacturing Quality Systems, processes.
21. Supports and promotes cost savings opportunities that work toward global objectives in the organization.
22. Fosters teamwork and supports total associate involvement.
23. Reports accidents, incidents, near misses, and hazardous situations in a timely manner and participates in the corrective action process.
24. Ensures compliance with company policies and procedures including safety.
25. Actively supports other plant functions in the implementation of company programs and projects.
26. Ensures laboratory test equipment is in a compliant state, including timely replacement and new equipment introduction
27. Facilitate the execution & performance of the Records Management Program as per PL553-005 & related RM documentation at Mentor Leiden.
28. Ensures proper Returned Goods evaluation
29. Owner of the contents of the Quarantine Area.
30. Ensures LIMS test logging is enabled, correctly executed and the system is updated properly as part of change management.
31. Ensure compliance with applicable laboratory regulations, standards and procedures
Other Responsibilities
- Performances absenteeism, mid-year and year end evaluations and conversations for direct reports and ensures they take place for direct reports.
- Establish objectives and development plans for direct and indirect reports or applicable processes.
- Interviewing, hiring, planning, assigning & directing work, mentoring, rewarding and disciplining employees, addressing complaints, resolving problems and issues.
- Trains, coaches and develops subordinates and Quality Operations function
- Develops the area (compliance, new technologies, lean)
Kwalificaties
Qualifications, Education, Skills & Experience:
HBO (BS) or University degree in Chemistry, Engineering
Minimum of 8-10 years in similar environment with medical device or pharmaceutical company, with relevant QA experience. Background in Statistics, Process Excellence is preferred. Supervisory Skills experience.
More information
Startdate: Jul 1, 2014
For more information regarding this position, please contact Sofie van Donselaar, Recruiter sdonsela@ITS.JNJ.com
Are you interested in this new challenge?
Please apply online
Primaire locatie: Europa/Midden-Oosten/Afrika-Nederland-Zuid Holland-Leiden
Organisatie: Mentor Medical Systems, B.V. (8808)
Functie: Kwaliteitscontrole
Omschrijving
Department:
Quality – Inspection & Testing Manager
Responsibilities & Accountabilities:
Under the direction of the Plant QA Manager and with the objective of maintaining high quality standards of the product manufacturing process and compliance with regulatory requirements, administers Quality Assurance laboratory support to the Quality Operations, and directly supervises Laboratory Supervisor, Laboratory Engineers in day to day activities supporting Breast Implant Business Unit has adequate laboratory support, test result reporting, test method validation, documentation review, and support projects, process and new product introductions or upgrading of existing processes and products and subsequent qualifications.
1. Leading, budgeting and resourcing a microbiology, analytical, incoming goods laboratory group. Directs and administers the activities of Lab supervisors, Lab Engineers and Lab technicians.
2. Carries out leading responsibilities in accordance with the organization’s policies and applicable laws including regarding health and safety.
3. Evaluates and recommends staffing requirements to ensure maximum utilization of personnel to fulfill department objectives.
4. Evaluates, recommends and approves expenses requirements to ensure maximum utilization of laboratory supplies to fulfill department objectives.
5. Approves purchases and expense reports submitted by direct reports.
6. Ensures that the quality and testing aspects for new processes, products and or upgrading of existing processes and products and subsequent PQ’s and PPQ’s are met.
7. Ensures that the testing at external supplier aspects for base business continuation, new processes, products and or upgrading of existing processes and products and subsequent PQ’s and PPQ’s are met.
8. Supports/Initiates investigations for non-conformances and OOSses.
9. Supports Operations in evaluation and implementation of actions plans to eliminate root causes of non-conformances.
10. Ensures incoming goods receipt, sampling and testing is performed supporting Operations Base Business Execution.
11. Ensures analytical, in process and finished device testing is performed supporting Operations Base Business Execution.
12. Ensures environmental and microbiology testing is performed supporting Operations Base Business Execution.
13. Ensures the coordination of test method, laboratory equipment validation (IQ/OQ/PQ) and acts as validation approver for Operations Validations.
14. Supports internal audit programs
15. Initiating and implementation of corrective and preventive action and quality data trending for CAPA review board evaluation.
16. SME during projects, regulatory, MDD and notified body audits/inspections.
17. Initiating and approval of labs and supplier quality related Non Conformances.
18. Promotes the use of Process Excellence tools to enhance analytical thinking and problem solving techniques.
19. Provides testing support to plant wide initiatives such as implementation of new initiatives safety, environmental and Quality related initiatives.
20. Supports on-going continuing efforts and projects to improve our manufacturing Quality Systems, processes.
21. Supports and promotes cost savings opportunities that work toward global objectives in the organization.
22. Fosters teamwork and supports total associate involvement.
23. Reports accidents, incidents, near misses, and hazardous situations in a timely manner and participates in the corrective action process.
24. Ensures compliance with company policies and procedures including safety.
25. Actively supports other plant functions in the implementation of company programs and projects.
26. Ensures laboratory test equipment is in a compliant state, including timely replacement and new equipment introduction
27. Facilitate the execution & performance of the Records Management Program as per PL553-005 & related RM documentation at Mentor Leiden.
28. Ensures proper Returned Goods evaluation
29. Owner of the contents of the Quarantine Area.
30. Ensures LIMS test logging is enabled, correctly executed and the system is updated properly as part of change management.
31. Ensure compliance with applicable laboratory regulations, standards and procedures
Other Responsibilities
- Performances absenteeism, mid-year and year end evaluations and conversations for direct reports and ensures they take place for direct reports.
- Establish objectives and development plans for direct and indirect reports or applicable processes.
- Interviewing, hiring, planning, assigning & directing work, mentoring, rewarding and disciplining employees, addressing complaints, resolving problems and issues.
- Trains, coaches and develops subordinates and Quality Operations function
- Develops the area (compliance, new technologies, lean)
Kwalificaties
Qualifications, Education, Skills & Experience:
HBO (BS) or University degree in Chemistry, Engineering
Minimum of 8-10 years in similar environment with medical device or pharmaceutical company, with relevant QA experience. Background in Statistics, Process Excellence is preferred. Supervisory Skills experience.
More information
Startdate: Jul 1, 2014
For more information regarding this position, please contact Sofie van Donselaar, Recruiter sdonsela@ITS.JNJ.com
Are you interested in this new challenge?
Please apply online
Primaire locatie: Europa/Midden-Oosten/Afrika-Nederland-Zuid Holland-Leiden
Organisatie: Mentor Medical Systems, B.V. (8808)
Functie: Kwaliteitscontrole