Manager QA Ops Aseptic Manufacturing, Transdermals & Secondary Packaging

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Description:

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, who can connect easily with our different business partners and is gets a lot of energy of developing young talent.

Job Description:

At the Janssen Supply Chain 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 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 of QA Operations Aseptic Manufacturing, Transdermals & Secondary Packaging 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
  
  

Job 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
  
  

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
  
  

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued andeach and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!