Responsible for the management of the quality assurance engineer staff to ensure optimal QA 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. Selects trains and develops key staff to ensure availability of resources to support the QMS objectives. Advises and supports decisions on significant quality and products issues. Manages allocated budget against approved plan. Participates as a member of the on- site QA management teamGMP/CORE JOB RESPONSIBILTIESManagement and co-ordinating of team activities, including but not limited to:
- Maintain documentation management / change control system and documentation archive.
- Risk management file maintenance
- Corrective and preventive actions (CAPA) program
- Quality assurance support of operations
- Quality assurance support of research project
- Quality assurance support of process development projects
- Execution and review of internal and supplier audits.
- Support external audits
- 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.
- Generation of QA engineering input for site QA planning and site business planning.
- 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.)
- Training and development of staff.
- Conducting departmental meetings
- Conducting performance reviews.
- Recruitment and selection of new staff (as required)
Education at higher vocational or university level
At least 5-7 years of relevant work experience, preferably in medical device/pharmaceutical industry with some level of supervisory experience.
A working knowledge of relevant GMP, QSR CFR 820 , ISO 13485, ISO 14971
Knowledge of relevant work instructions and procedures
Knowledge of MS Office
Flexible in undertaking tasks and working hours
Ability to operate and maintain relationships at different levels within the organization
Effective communication skills and ability to work across the organization
Decisive and with the ability to set the correct priorities
Ability to manage a number of priorities at the one time
Ability to use own initiative and make the difficult decisions.
Can lead and drive the changes necessary to build the business
Excellent command of the English language (verbal and
AMO Groningen BV (8358)