You will be responsible for the management of the AMO Groningen testing laboratories, and the QA technician staff to ensure optimal QC support to the organization (operations and projects). Drive compliance improvements and ensure applicable site, division, corporate and external compliance requirements are met. Provides policy input to site quality head function.
GMP/CORE JOB RESPONSIBILTIES
Management and coordination of team activities, including but not limited to;
• Complaint handling
• Execution of; chemical, optical, mechanical and microbiological product related testing.
• Site Environmental monitoring program
• Final product release by Device History Record review.
• Sterility assurance and associated validations.
• Execution and review of statistical analysis supporting the implementation of statistical process control, sampling and other quality tools.
• The generation and review of qualification and validation protocols and reports
• Assigning staff based on priority and individual competencies / experience.
• Co-ordination with staff members and other departments to ensure that targets / goals are achieved.
• As appropriate escalation of issues to site Quality head function
• Ensure that quality awareness is improved in the organization.
Execution of site / division and corporate policies to ensure compliance to applicable internal and external regulatory requirements:
• Generation of department plan to support site QA planning and site business plan.
• Generation and control of department budget on the basis of expected developments (projects, capacity and consumables).
• Ensure appropriate employee behaviors and where necessary address employee behavior issues with respect to AMO procedures (including but not limited to; safety, hygiene, compliance etc)
Management of staff:
• Training and development of staff.
• Conducting departmental meetings
• Conduction performance reviews.
• Recruitment and selection of new staff (as required)
REQUIREMENTS
• Education at higher vocational or university level (preferably in the subject of chemistry, microbiology or another technical subject)
• Education at higher vocational or university level (preferably in the subject of chemistry, microbiology or another technical subject)
• Knowledge of relevant GMP, QSR CFR 820 , ISO 13485, ISO 14971
• Knowledge of relevant work instructions and procedures
• Knowledge of MS Office
Attitude/Competencies:
• Flexible in undertaking tasks and working hours
• Ability to operate and maintain relationships at different levels
• Communication skills
• Decisive and with the ability to set the correct priorities
• Has a helicopter view
• Target-led
• Client-led
• Ability to realise close-knit and high-quality alliances
• Has strong leadership qualities
• Excellent command of the English language (verbal and
• written)
Primary Location
Netherlands-Groningen-Groningen-
Organization
AMO Groningen BV (8358)
Job Function
Quality
Requisition ID
2105966222W