Effectively manage Contract Manufacturing and Quality Control testing laboratories in support of GMP manufacturing. This objective includes method and process transfer, validation, manufacturing, testing, release and distribution of vaccine products.
Provide QA guidance and support to R&D CMC groups within Takeda Vaccines (Montana).
Ensure GMP compliance for all manufacturing and testing related to products for Takeda Vaccines (Montana).
Review and approve batch records, prepare annual product reviews, process technical complaints.
Review and approved documentation for tech transfer and validation of analytical methods and manufacturing processes.
Conduct investigations into Good Manufacturing Practice (GMP) related issues or problems associated with audits, batch records, and complaints. Assist with management of manufacturing deviations, out-of-specification results, and investigations.
Prepare Chemistry, Manufacturing, and Controls (CMC) information for Investigational New Drug (IND) annual reports. Participate in the resolution of problems/concerns.
In conjunction with contractors, develop and oversee packaging and labeling for Chemical Trial Materials (CTM). Arrange for testing of CTM and review data for acceptance.
Conduct audits at contract manufacturing, testing, packaging, and warehouse/distribution operations to assure adherence to regulatory requirements. Issue audit reports and follow up on corrective actions.
Maintain QA records according to applicable regulatory requirements and Takeda policy.
Manage Reference Materials for use in analytical assays to support R&D and GMP testing.
Manage a scheduled, documented training program in appropriate areas of regulatory compliance.
Other duties as assigned. Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Bachelor’s Degree or higher in a scientific discipline.
Minimum of 2 years experience in quality or regulatory compliance within the pharmaceuticals, biologics, or other related industry(ies).
Good Manufacturing Practice auditing and training experience.
Experience with equipment, analytical method and process validation is a plus.
Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
Lifting and moving supplies and equipment (up to 25 pounds).
Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
Requires approximately 25 % travel.
We are driven to improve people's lives.
We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
Takeda Pharmaceuticals - 21 months ago