Quality Assurance Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United States
San Francisco, USA
Posting date: 08 Jun 2021
QA.BC.38070

Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in San Francisco, CA.

Job Responsibilities:

  • Support quality management implementation and maintenance
  • Focus on the management of authorized activities and the accuracy and quality of records
  • Ensure initial and continuous training programs are implemented and maintained
  • Approve any subcontracted activities which may impact on GVP
  • Ensure that root cause analysis is conducted for all audit findings and that CAPA are developed and implemented in a timely manner
  • Keep appropriate records of any delegated duties

Skills and Requirements:

  • 0-3 Years of Experience
  • Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
  • Strong leadership ability.
  • Good knowledge of government regulations and guidelines ( local, EMA, FDA, PMDA) pertaining to pharmacovigilance
  • Strong knowledge of pharmacovigilance AE reporting systems and regulations required
  • Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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