Responsible for the management of the quality assurance engineering staff to ensure efficient QA management, coordination and 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 all aspects of the quality system. Selects trains and develops key staff. Manages and co-ordinates the team workload to ensure availability of resources to support the QMS objectives. Facilitates discussion and supports decisions on significant quality and products issues. Provides oversight of allocated budget against approved plan. Participates as a member of the on- site QA management team
GMP/CORE JOB RESPONSIBILTIES
Management 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
Leads quality assurance support of operations
Leads quality assurance support of research and process development projects
Leads and executes the review of internal and supplier audits.
Supports 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 proficiencies / 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 QA engineering input for site QA planning and site business planning.
Generation and control of department budget on the basis of proposed 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
Conducting performance reviews.
Recruitment and selection of new staff (as the need arises)
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 solid understanding of relevant GMP, QSR CFR 820 , ISO 13485, ISO 14971 Knowledge of MS Office
Flexible in undertaking tasks and working hours
Ability to operate and maintain relationships at different levels within the organization
Effective interpersonal skills and ability to work across the organization
Decisive and with the ability to set the correct priorities
Ability to handle 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 written)
This GMP Job description is a job profile with a general description of core tasks, responsibilities and job requirements. For a more specific description of tasks and responsibilities, reference is made to the currently applicable procedures and work instructions. No rights can be derived from this document with regard to weighing and valuing of functions.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
AMO Groningen BV (8358) Job Function
Quality Requisition ID
Open Positions from Johnson & Johnson Family of Companies