Manager QA Ops Eyecare/tds/pellets Jsc Beerse
il y a 3 semaines
We are looking for an employee that has a passion for quality and loves to operate in a very dynamic pharmaceutical production environment. We are looking for an employee that likes to work with people, has the ability to connect easily with our different business partners and is gets a lot of energy developing our young talent.
At the JSC Beerse site, different product types are being produced and released such as Steriles, Liquids & Creams and Transdermals.
The Janssen Beerse Site Quality Department ensures that all GMP activities of manufacturing, packaging, labelling, testing, release and distribution of Investigational and Commercial Products at/from the Campus Belgium are carried out as required by GMP legislation.
Within this department, the QA Operational group is responsible to ensure compliance during the daily operational aspects in the production plants.
As Manager QA Operations Eyecare/TDS/Pellets you will lead and manage the Quality Operations team supporting the manufacturing area to assure the safety, efficacy and timeliness of product supplied to patients via the deployment of suitably qualified / validated manufacturing, testing, distribution and management processes, and to satisfy all internal and external regulatory expectations
- Together with your team you support the daily quality operations within the manufacturing area:
- the release of products
- support and approval of investigations and related capa’s
- Review and approval of change controls
- Review and approval of validation documentation
- Handle customer complaints
- Attend tier 1-tier 2 meeting within the production plant
- Approve APR (annual product reviews)
- Prepare and attend monthly QIP (quality improvement plan) meetings
- Continuously challenge the status quo and lead the development and implementation of breakthrough initiatives that deliver sustainable 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
- Manage the writing and/or QA approval of GMP documents (work instructions, SOPs,) to ensure QA oversight of the operational activities
- Support the preparation, execution and follow-up of internal and external inspections
- Ensure that the internal audits are executed and reported according to internal audit schedule
- Manage, coach and develop a team of 8 quality experts reaching their quality, business and personal objectives
- Establishing and maintaining effective working relationships with the different business partners
**Qualifications**:
- University degree, scientific orientation (pharmaceutical, chemical or biological sciences/engineering)
- 5 years experience in pharmaceutical industry
- In depth understanding of pharmaceutical production (manufacturing and packaging) and the specific technologies that are being applied, qualification, validation, testing, release
- Thorough 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 win-win solutions
- Understands the business implications regarding quality positions and decisions
**_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. _
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