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EMEA Q&C Lead
Requisition ID: 1805645352W
Johnson & Johnson Services, Inc. is recruiting for a EMEA Q&C Lead to be in Istanbul, Turkey.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $70.1 billion in 2015 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. There are more than 265 Johnson & Johnson operating companies employing approximately 126,500 people and with products touching the lives of over a billion people every day, throughout the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
Duties & Responsibilities
External manufacturers (EM):
- To manage the assigned EM(s) portfolio against the acceptable GMP and applicable ISO Standards (i.e: 9001; 13485)
- To participate to due diligences and to carry out GMP/for cause audits and technical support
- Follow-up audit action plan proposal and progress
- To develop and carry out the approval process of the new EM according to the current GMP, ISO and J&J requirements
- Laboratory qualification
- To manage quality issues: review of deviations, out of specifications, non-conformances and other critical issues; investigation review, follow up on resulting action plans
- To assure continuous improvement process of the External Manufacturers through KPI and Management Action Plan and CAPA follow-up
- To collect change control related information from EMs, evaluate proposed changes, collect R&D, regulatory and procurement assessments, prepare action plans and follow up, evaluate product documentation, assess validation protocols and reports
- To review of complaints, support of complaint investigation, follow up of EMs action plan resulting from complaint investigations
- Collect and review of PQRs, follow up on resulting action plan with the assigned EM(s)
- To review of stability data, follow up on action with the assigned EM(s)
- To lead and follow-up on the implementation of the different QA projects/new WWSP (Worldwide Standard Procedures) at the assigned EM sites
- To regularly communicate status & results (including escalation)
EMEA Regional Program:
To take part in ERC initiatives at the EMEA regional level within the EMEA regional departments and at the assigned EM(s) sites
To take part in the implementation of the different QA projects / new J&J standards at a regional and global level
Support to EMs Business & External Growth:
QA support in Business Continuity Plan (BCP) / Reformulation / CIPs
Support in supplier reliability initiatives as agreed with line manager and Q&C Projects' leader
EM business meeting / support to SRM program
- A minimum of a Bachelor's Degree is required in Engineering, Pharmacy, Chemistry, Life Science, or related disciplines.
- 5 -8 years of relevant experience
- Excellent communication skills
- Fluency in English is a must
- Ability to reside in Istanbul
Johnson & Johnson Sihhi Malzeme Ltd. (7347)