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Quality Assurance Specialist
- Permanent
- Good Pharmacovigilance Practice (GVP)
- United States
This vacancy has now expired. Please see similar roles below...
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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