Process Validation Consultant
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!
Our client is looking for Manufacturing and process validation consultant who has an extensive experience in the Plasma and Plasma Derivatives products.
We prefer to have a consultant who has +3-5 years recent experience in the plasma, plasma derivatives products and +10 years in this industry.
Scope of Work
As assigned by the client management, consultant to provide validation protocol and report writing services associated with:
- Writing validation protocols and reports, including but may not limited to, equipment, facilities, utilities, and process
- Addressing validation gaps by developing or updating protocols and reports
Documents in Scope
- Process validation
- Cleaning validation
- Media fill test
- Mixing study
- Hold time study
- Re-use validation
- Validation Master File and Validation Master Plan SOP (Validation)
Consultant responsibilities are:
- Develop validation reports that reflect the protocol requirements and 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
- Write validation reports with focus on the following reviewers in mind:
- The client's quality assurance
- Regulatory agencies
- The client's customer
- 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.
- Mentor validation staff, individually and in groups as requested, on the components of this SOW to help build staff understanding and competence.
- B.S. or advanced degree in chemistry, biology or related science with + 10 years experience in pharmaceutical / biopharmaceutical industry.
- +3-5 years experience in the blood-derived or plasma products.
- 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.
- Working in Korea is required.
- Have experience in writing documents from-scratch or through adaptation as appropriate.