[Janssen Vaccines] Sr. QA Specialist
At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal. Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
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1. ???: Sr. QA Specialist (7-9 years of experience)
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[Main responsibility]
- Provides quality support of manufacturing activities (e.g., Aseptic Drug Product processing, Validation of cleaning & sterilization) / utility management activities (e.g., HVAC, water system, BMS, maintenance, calibration)
- Performs QA on the shop floor activities and support of continuous quality improvement initiatives to cultivate a culture of proactive quality in collaboration with cross-functional team
- Reviews related procedures and documents
- Support non-conformance investigations and CAPAs in compliance with GMP requirements and company procedures
- Evaluates change proposals for impact and risk through change management/change control system and support coordination of cross-functional implementation plans
- Supports audit / inspectional readiness activities to prepare the site for internal independent audits and health authority inspection
- Perform tasks in a manner consistent with the safety policies, quality systems, and FDA/EU requirement
- Provide leadership and insight to assist the team performance as a senior staff in the team.
- Conducts / supports training on decisions / conclusions of manufacturing / engineering activities from quality point of view
[Requirement]
- A minimum of Bachelor’s degree is required, in life sciences or related field, such as Biology, Chemistry, Microbiology, Engineering, Pharmacy, etc.
- More than 7 years of experience in a pharmaceutical industry, preferably in sterile manufacturing environment
- Good verbal and written communication skills in English/Korean, facilitation, and presentation skills
- Good technical writing skills
- Strong organizational skills, including ability to follow tasks through to completion. Skills in prioritizing and meeting deadlines
- Represent Quality in technical and/or other tactical cross-functional meetings
- Ability to identify opportunities for improvement
- Word processing, presentation, spreadsheet and database skills
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https://careers.jnj.com -> Requisition number “2406212549W” ?? -> ?? ?? ?? ?? ?, “Apply Now”
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www.careers.jnj.com