Quality Assurance Validation Engineer in St. Louis, MO at Apex Life Sciences

Date Posted: 7/19/2018

Job Snapshot

Job Description


QA Validation Engineer needed in St. Louis MO

Responsibilities:

  1. Prepare, execute, and summarize qualification protocols and related documents (risk management, periodic reviews, URS, FRS, IQ, OQ, PQ, PV, FAT…etc) to support the following:
    1. Solid Dosage Equipment
    2. Utilities
    3. Process Validation
    4. Re-qualification of existing manufacturing equipment and utilities
  2. Develop and write quality discrepancies and investigations associated with the validation studies.
  3. Work closely with manufacturing, laboratory, both QC and R&D, for sample coordination and to ensure required samples are process and tested as required during protocol execution.
  4. Ensure validation studies of the manufacturing, QC, R&D, and facilities utilities serving the functional areas to ensure all testing equipment is complete to the required cGMP standards.
  5. Supervise production operators, QC, and R&D analyst during validation studies, as required.
  6. Prepare change control documentation for validation activates.
  7. Design maintain and continually improve the validation systems in line with current national and international standards. 
  8. Provide technical expertise and guidance on validation policies and procedures and the implementation of those within QC, manufacturing, and R&D functional areas. 

Requirements:

  1. Good working knowledge of cGMP and regulatory standards for validation
  2. Experience in writing & reviewing SOPs and protocols for accuracy, traceability and compliance
  3. Minimum 5 years’ experience leading people
  4. Experience with GAMP standards
  5. Bachelor of Science or Engineering degree
  6. Minimum 3 years’ experience in performing and leading validation studies within the pharmaceutical industry

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.