Sr. Process Validation Consultant Plasma Products

Location
South Korea
Posted
May 04, 2018
Ref
1EB-1187731297
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!

Scope of Work

Consultant to develop and execute complete validation program for client:
  • Development of the validation master plan
  • Developing protocols, assisting with protocol execution, and development of final reports. Includes review of completed packages.
  • Scope of validation includes cleaning, process, hold times for product and solutions/buffers, filter resuse, equipment hold times.
  • Review validation packages already completed/executed by client.

Client has two sites: Montreal, Canada and South Korea. Project expected to kick-off at Montreal site and transition to South Korea site.
Our client is looking for Manufacturing and process validation consultant who has an extensive experience in the Plasma and Plasma Derivatives products.

Documents in Scope
  • Process validation
  • Cleaning validation
  • Media fills
  • Mixing studies
  • Hold time studies
  • Filter re-use
  • Validation Master Plan
  • Validation Program SOP

Consultant responsibilities are:
  • Develop validation master plan for blood-derived parenteral product.
  • Develop validation protocols and reports including acceptance criteria.
  • Develop reports that are clear, concise, complete, and meets the client's quality requirements.
  • Review executed protocols and data to meet quality compliance requirements:
    • No errors or omissions
    • All entries are complete, traceable, and legible
    • All data reports and printouts are included
    • Exceptions are documented and resolved
    • The executed protocols have been QA reviewed and approved
    • Adhere to good documentation practices (cross-outs are dated/initialed, no pencil)
  • Facilitate reconciliation and correction of issues on executed protocols
  • Develop validation documentation with focus on the following reviewers in mind:
    • The client's quality assurance
    • Regulatory agencies
    • The client's customers
  • Perform all technical writing with focus on clarity, conciseness, grammatical and mechanical correctness, accuracy, and completeness. Adhere to the client document styles and templates as applicable.
  • Facilitate the report review and approval process within applicable turnaround times or as needed to meet client timelines.
  • Provide general technical support as requested. Align closely with parallel technical and compliance activities and deliverable to ensure a defendable and aligned validation strategy for the client.
  • Mentor validation staff, individually and in groups as requested, on the components of this SOW to help build staff understanding and competence. This will include sharing information associated with regulatory guidance documents and industry best practices.


Qualifications:

B.S. or advanced degree in chemistry, biology or related science with 15+ years experience in biologics industry, primarily in validation roles. Expertise in blood-derived or plasma products required.
Ideal candidate will have experience managing complete validation programs, with demonstrated technical and leadership skills.
Ability to deal with ambiguity, creative approach to problem solving and ability to define a clear path forward with emphasis on keeping things simple.
Proven ability to lead quality initiatives effectively and advocate a strong quality culture.
Strong organizational skills, able to prioritize work, effectively manage multiple projects while maintaining attention to detail and meeting timelines.
Ability to work effectively with various technical and operational groups, with strong oral, written and interpersonal skills.
International travel is required. Comfortable working with different cultures and languages.
Must be able to work in Korea and Canada, and have a valid US Passport.

Position Id
EB-1187731297