Description:
Responsibilities
- This position will be responsible for reviewing and approving specifications, qualification protocols, data packs and qualification summary reports associated with Facility, Utility and Equipment’s (FUE) and Process (MTech Studies) associated with B200.
- Apply and interpret CGMP, regulatory requirements, standard, directives and guidelines from Corporate Quality management and regulatory agencies, to ensure records are clearly and appropriately justified.
- Represent Quality Operations in various meetings for the FUE and MTech Studies and will provide guidance adhering to Global Quality Directives, Pharmaceutical Industry Standards (i.e., GAMP, ICH, ANNEX), Code of Federal Regulations.
Qualifications
- Must have a minimum Bachelor’s degree in pharm D
- 7+ years of experience in Pharmaceutical / Biotechnology with strong project management skills
- Strong attention to details, effective time management, ability to multi-task, strong teamwork and collaboration skills.
- Effective interpersonal skills.
- Works well with others at all levels of the organization.
- Work in a self-directed manner to see issues through completion.
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Job Types: Full-time, Fixed term contract
Contract length: 12 months
Schedule:
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