QA Manager J&j Im Sc Beerse
il y a 1 jour
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver significant solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we cultivate a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
At the J&J IM SC Beerse site, we produce and release a variety of product types, including Steriles, Liquids & Creams, and Transdermals. The Janssen Beerse Site Quality Department ensures that all GMP activities—spanning manufacturing, packaging, labeling, testing, release, and distribution of commercial products from the Campus Belgium—are conducted in full compliance with GMP legislation.
Within this department, the QA Lab team plays a meaningful role in ensuring compliance with daily quality control testing activities. Additionally, the team is responsible for the release of excipients and packaging materials for further processing.
As the Manager of the QA Lab, you will lead and run the QA Lab team, supporting the physico/chemical, microbiology, and packaging labs. Your focus will be to ensure the safety, efficacy, and timely delivery of products to patients, achieved through the deployment of appropriately qualified and validated testing and material release processes. You will also ensure compliance with all internal and external regulatory requirements and expectations.
Together with your team you support the daily quality operations within the quality control area:
- Support and approval of investigations and related capa’s.
- Review and release of excipients and packaging materials.
- Review and approval of change controls.
- Review and approval of trend review reports.
- Attend tier meetings within the QC Lab and QA Lab team.
- Prepare and attend QIP (quality improvement plan) meetings.
- Continuously challenge the status quo and lead the development and implementation of breakthrough initiatives that deliver balanced improvement in organizational and quality performance.
- Continuity of supply: interface daily with Planning, Manufacturing, Packaging, QC and Supply Chain groups to assure that adequate resources are available to support the twin goals of customer service and inventory minimization, report on resources issues and operating constraints
- Lead the writing and/or QA approval of GMP documents (work instructions, SOPs,) to ensure QA oversight of the quality control activities.
- Support the preparation, execution and follow-up of internal and external inspections.
- Ensure that the internal audits are implemented and reported according to internal audit schedule.
- Run, mentor and develop a team of 6 quality experts reaching their quality, business and personal objectives.
- Establishing and ma
**Qualifications**:
Job Qualifications:
- University degree, scientific orientation (pharmaceutical, chemical or biological sciences/engineering).
- 5 years experience in pharmaceutical industry.
- In depth understanding of pharmaceutical production and QC testing.
- Detailed knowledge of pharmaceutical legislation, in cGMP regulations (domestic & international), ICH guidelines, policies, standards and procedures.
- Strong analytical thinking, risk assessment, managerial and leadership skills.
- Ability to provide operational leadership to meet business objectives in a highly dynamic business environment.
- Excellent communicator, ability to building a network and create effective solutions.
- Understands the business implications regarding quality positions and decisions
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