Pharmaceutical Clinical Associates, LLC
-
Raritan,
NJ
Plan and conduct cGMP audits ofGMP systems. Assists in performing audits of contract manufacturers suppliers etc. Participates in Pre-Approval Inspection Readiness audits for facilities and contract manufacturers. Issues audit reports, recommend corrective action and conduct follow up to audits and corrective actions. Performs compliance review of all non-conformances. Review and recommend compliance related policies/procedures. Evaluate impending regulations, guidelines and industry standards and their impact on the company. Assist in regulatory inspections as needed. Note this position requires approximately 10% travel.
Experience and Skills:
1. A BA/BS degree in the sciences or equivalent experience. 2. Minimum of 3 years experience in the Biopharmaceutical industry including at least 2 years experience auditing manufacture ring processes and laboratories as well as Quality Systems. 3. Demonstrates a thorough knowledge of cGMP regulations and other regulations as applicable. 4. Is familiar with Biotech manufacturing. 5. Possesses a conceptual understanding of all Quality functions and business areas. 6. Excellent written and oral communication skills and must be computer literate.
Additional Information:
Job Level: Mid Career (2+ years)
Number of Openings: 1
Years of Experience: At least 2 Years
Level of Education: BA/BS
Salary: TBD
Starting Date : TBD
Email Job To A Friend
Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Raritan, NJ
Raritan, New Jersey
|
|
|
