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Senior Specialist Quality Systems 80-100%, Fixed-Term, 10 Month Req.: 2506231618
vor 2 Wochen
This position may represent Quality on APR/PQR (Annual Product Review/Product Quality Review) by being responsible for on time completion of APR/PQR activities, guiding, setting, and standardization of quality/compliance requirements, development of SOPs and providing practical solutions in collaboration with the APR/PQR process owner and contractor. This individual will comply with applicable regulations and meets the needs of the business and supply chain.
Responsibilities:- Subject Matter Expert (SME) for APR/PQR quality systems processes, procedures, and activities. Remain current on assigned quality system training and seek out training and knowledge in adjacent areas.
- Work in close collaboration with APR/PQR process owner and external contractor team. Provide overview or detailed proactive communications to process owner and global APR/PQR teams.
- Lead through the review and on time completion of APR/PQR by collaboration with cross-functional teams.
- Act as an SME on APR/PQR during inspections and audits.
- Conduct, execute and document thorough investigations and CAPAs, Audit responses
- Ensure timeliness of results through independent, proactive intervention.
- Bring forward innovative process improvements to drive compliance and/or efficiency and implement improvements as part of the global APR/PQR community.
- Contribute to continuous improvement projects in regards to standardization and simplification.
- Independently handle and prioritize highly complex and diverse workload ensuring deliverables are timely, accurate, and meet their intended objective.
- Review and approve compliance records, procedures and other documents, as required by procedure.
- Identifies, supports assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, actions, and recommendations.
- A minimum of a Bachelor’s Degree is required, preferably in Engineering, Chemistry, Biology, Biological Sciences or Food Sciences field.
- A minimum of five (5) years of GMP experience in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic Production is required.
- Alternatively, a minimum of a laboratory technician EFZ, preferably with HF certification and a minimum of seven (7) years of experience in and outside of Quality Control with increasing responsibility
- Proven ability to lead and influence others with very good communication and presentation skills.
- Experience and demonstrated skills in navigating in a matrix environment, handling complexity, collaborating across boundaries, and influencing without authority required.
- Ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution.
- Demonstrated skills in Process Excellence preferred
- Strong communication (verbal & written) and interpersonal skills, self-awareness and flexibility required.
If you are a team-oriented, open-minded dynamic and highly motivated person with strong interpersonal skills you might be the one we are looking for. For collaboration with different departments, you will need flexibility, social competence, and a reasonable degree of authority. You will take decisions independently and provide advice as needed.
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 meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster 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 jid2767365a jit0104a