What are the responsibilities and job description for the Good Clinical Practices (GCP) Auditors position at PharmaLex?
PharmaLex is a highly successful and growing consulting company for the Lifesciences industry. We are experiencing an increase in demand for Good Clinical Practices (GCP) Auditors and our goal is to grow our consultant network to prepare for upcoming projects.
General Description:
We are seeking independent consultants interested in working on a project by project contract basis, to provide GCP Auditor services or GCP Operations quality services covering all aspects of clinical trial execution for our pharmaceutical and biotechnology clients.
Work Arrangement/s: Onsite or Remote
A successful candidate to perform this project must possess the following Technical skills:
- Bachelor’s degree (or higher) in Pharmacy, life sciences, or related discipline and 10 years of relevant experience working within the pharmaceutical or biotech industry.
- Working knowledge of global GCP requirements including industry quality systems/standards.
- Proven experience in set up of Quality oversight procedures and Quality Systems for Clinical trial Operations.
- Ability to apply appropriate GCP regulatory knowledge to multiple scenarios.
- Minimum 2 years GCP auditing experience; Certified quality auditor is a plus.
- Familiarity with GCP computerized systems used in support of Clinical trial execution
- Clinical laboratory auditing experience a plus.
- Investigator site auditing experience is a plus.
- Experience with set up or auditing of CROs is a plus.
- Demonstrated technical writing & speaking fluency in English.
- Advanced regulatory knowledge acquired through experience in the pharma industry or clinical application.
- Experience as an independent consultant to Bio/Pharma is a plus.
- Ability to work across functional areas, or previous client engagement experience, such as CRO or similar is a plus.
PharmaLex is an Equal Opportunity Employer.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.