QC Lab Consultant - PAI readiness

Location
Yongin-si, Gyeonggi-do, South Korea
Posted
May 04, 2018
Ref
1EB-8903225293
Required Education
Bachelors Degree
Position Type
Full time
As a member of the Bulletproof family, you'll enjoy a culture that values diversity in all things - people, work, experience levels, and much more. We tackle the toughest challenges, produce impactful results, and build solid client relationships along the way - with energy, passion, and fun. If this sounds like a good fit for you, please consider this exciting opportunity with our firm!

Project:


The Consultant will work in a well-rounded and multi-faceted capacity on key product activities and project initiatives associated with QC laboratory management. Responsibilities focused on development and/or gap analysis and remediation of QC laboratory SOPs to bring them into cGMP compliance. Client manufactures blood plasma products and is preparing for PAI in 2019.

Duties/Responsibilities:
  • Author new procedures and/or significantly revise existing SOPs for commercialization and FDA PAI readiness
  • Align and imbed with industry best practices and cGMP compliance solutions
  • Apply cGMP knowledge and experience to QC laboratory processes to ensure best practices, efficiencies, and error reduction
  • Partner closely with client to help build quality culture and understanding of FDA expectations in a cGMP environment
  • Perform change control activities for all documents and activities in scope to closure
  • Meet project timelines.
  • Align with and execute work in accordance with project objectives, directives, and decisions
  • Work independently to minimize client time while building a transparent and inclusive partnership with client and co-workers.
  • Mentor clients and junior staff throughout process to build a quality mindset and encourage adoption of proposed improvements.
  • Provide additional regulatory and QC support as requested.
  • The types of processes in scope may include Management of Reagents, QC Training Program, and Data Integrity.

Requirements:
  • BS and approximately 15 years (or more) of pharmaceutical (biologics) industry experience in QC lab environment, with some of that time in laboratory management or quality systems ownership role
  • Experience in implementing compliant laboratory systems in commercial multiproduct manufacturing environment.
  • Comfortable working with electronic lab management systems and paper-based systems
  • Excellent written and verbal communication skills; impeccable attention to detail
  • Comfortable working with individuals from other cultures and backgrounds
  • Demonstrated ability to meet timelines
  • Must be able to work in Korea and have a valid US Passport (total project duration is 8 weeks/ 2-3 weeks site visit in Korea and 5-6 weeks remote consulting)


Position Id
EB-8903225293