QA Director NY

3 days ago

islip, United States Nesco Resource Full time

Nesco has partnered with a leader in the pharmaceutical industry in their pursuit to hire a QA Director. Join one of the most respected organizations in the industry as they continue to grow and expand their portfolio. If you have leadership experience and expertise within the operation quality of pharmaceutical drug products, we want to talk to you
Responsibilities of the QA Director:

  • Develop, establish and maintain Quality Management System as per 21 CFR Part 11 requirements for products manufactured at New York facility.
  • Accountable to ensure product quality of all manufactured and released products at site.
  • Ensure compliance of products manufactured at site.
  • Review and or approval of Deviation, change control, CAPA, complaints and Laboratory non-conformance.
  • Ensure the highest standard of Data integrity is maintained at site.
  • Ensure compliance of all quality unit personnel in maintaining a safe work environment.
  • Ensure compliance with cGMP as laid down in the procedures.
  • Accountable for Batch disposition based on its testing results.
  • Development of talent in the Quality organization.
  • Subject matter expert on technical and compliance issues related solid oral drug products and Drug Device combination products.
  • Ensure and maintain the facility as per all-time audit readiness mode.
  • Conduct management review meetings to apprise Senior management on the effectiveness of QMS for combination products and other Drug products manufactured in the facilities.
  • Ensure compliance with all good documentation practices.
  • Ensure adequate investigation and timely closure of QMS action items.
  • Ensure implementation and effectiveness check of global CAPA at site.
  • Ensure Qualification and validation of Equipment's, Facilities and Process for the sites,
  • Support for submission of internal and external audit response on timely manner.
Requirements
  • 10 to 15 years of experience in areas of Operational quality including at least 5-7 years in a leadership role in a Regulated Pharmaceutical Industry environment.
  • BS degree in science/pharmacy or equivalent area of Science. Master's degree in a science-related field is preferred.
  • Must have experience with Drug Device combination products.
  • Should have all required regulatory compliance knowledge and competency for drug product manufacturing, environmental monitoring, area classification requirements.
  • Possess excellent Technical Writing capabilities.
  • Proficiently communicate and understand (speak, read and write) scientific work in English.
  • Have excellent communication and coaching skills.
  • Ability to understand and analyze complex data sets.
  • Strong desire towards continuous improvements.
  • Proficient with Microsoft Office programs and other software based QMS platforms like Master control, Tracwise

 
Comprehensive benefits package to include a 401(k) savings plan and matching, health insurance – medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) – vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

  • Nesco Resource | QA Director NY

    3 days ago

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    Nesco has partnered with a leader in the pharmaceutical industry in their pursuit to hire a QA Director. Join one of the most respected organizations in the industry as they continue to grow and expand their portfolio. If you have leadership experience and expertise within the operation quality of pharmaceutical drug products, we want to talk to...

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