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Technical Manager, EQA
Ref No.: 17-14181
Location: South San Francisco, California
Job Title: Technical Manager, EQA
Job Company: Major Pharma
Job Category: Quality
Job Location: SSF, CA 94080
Job Duration: 6 months contract; Replacement

Job Description:
  • Ensure the manufacture and disposition of clinical supplies of COMPANY Small Molecule GMP intermediates, APIs and Drug Products including primary packaging at CMOs is conducted in accordance with cGMP.
  • Create and maintain Quality Agreements & Product Specifications from a template.
  • Review and approve CMO master batch records for compliance to regulatory filings, product requirements, and cGMP compliance.
  • Review executed batch records, assess deviations/investigations.
  • Review and approve CMO analytical method transfers and method qualifications protocols/reports with COMPANY QC.
  • Implement process improvements.
  • Represent External Quality to support Quality Subteams.

Desired Skills:
  • At least 8 years clinical development experience with Small Molecules Development in particular in API and solid dosage form manufacturing
  • At least 4 years direct experience in Quality for pharmaceutical operations
  • At least 3 years experience in operating quality systems in pharmaceutical operations
  • Demonstrated proficiency in interpretations of cGMP regulations, both US and international
Education:
BS/MS in life sciences or equivalent

Required:
BATCH RECORD
CGMP
CMOS
FILINGS
PACKAGING
LIFE SCIENCES
API
AUDITS
SAMPLING
PRODUCT SPECIFICATIONS