€ 3,500 - € 6,000
Detachering via YER
Medical & Health
Over deze vacature
The QA officer level 2 is a position within the center of excellence Quality Operations (CoE QO). The CoE QO is comprised of several departments designed to oversee manufacturing activities in accordance with current Good Manufacturing Practices (cGMP), responsible for manufacturing, receipt, storage, testing, processing, packaging, release, holding, labeling and distribution activities during the life cycle of products. QA officer lvl2 will be positioned within the QA-IPT department.
The QA officer level 2 is responsible for providing advice, support and approval during:
- Equipment installation, - qualification and –validation and
- Root cause investigation and corrective and preventive actions.
In addition, the QA officer level 2 reviews and approves standard production documentation and protocols and acts as a subject matter expert for the organization with regard to maintaining GMP compliance within the operational processes.
Position in organization
- Reports to: QA-IPT lead
- Subordinates: No
To ensure that daily operational activities are performed in accordance with guidelines and policies. Support and approve deviation handling, change control and validation activities. Act as a first point of contact for the production departments for all issues related to GMP compliance.
Expected results/functional activities:
- Review and approve templates for batch manufacturing and batch filling instructions.
Deviation and change management
- Support root cause analysis in case of deviations.
- Inform or involve the Qualified Person in case of deviations with potential product quality, safety or compliance impact.
- Approve root cause investigations and associated conclusions.
- Approve corrective and preventive actions.
- Review and approve change proposals.
Validation and qualification
- Support qualification and validation activities as subject matter expert.
- Review and approve qualification/validation protocols/reports.
- Perform witnessing during media simulations and operator qualifications.
Audits and health authority inspections
- Support during health authority inspections.
- Coach/mentor for QA officer lvl1.
- Act as subject matter expert with regard to GMP compliance.
Sub System Owner (optional)
- Acts as Sub System Owner on system level and is a representative for the assigned Quality System.
- Supports as Sub System Owner inspections by authorities.
- Is TLP/SOP/WI owner.
- Responsible for metrics for site Quality, global Quality and Business Review meetings.
- Production departments
- Maintenance and reliability
- Customer and production planning
- Quality control
- Qualified person
A global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, they are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Their ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, they strive to create an environment of mutual respect, encouragement and teamwork. As part of their global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
You will be employed by YER and seconded to our client.
Our professionals are the key to our clients’ success. We demonstrate our commitment to our professionals by offering:
- Good employee benefits (e.g. work-life balance, pension, travel allowance/lease car)
- Personal guidance from your consultant customized to your preference
- Provide development opportunities and career advice
- Intensive support for international candidates (including Dutch lessons, tax-return and accommodation assistance)
- A community/network of with other YER professionals from a variety of multinationals
- Events and masterclasses with interesting speakers and attractive companies
- Higher education degree (HBO/university or equivalent)
- At least 3 years of relevant Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with demonstrated experience in investigations, change control, validation and/or audits.
- Extensive knowledge of Good Manufacturing Practice with the ability to interpret and apply in both routine and non-routine cases.
- Knowledge of manufacturing processes and operations.
- Business proficient knowledge of Dutch and English language is mandatory