Job Description
Job Description Primary responsibilities of this role include the following:
- With Supervision, review documents/records and provide batch release authorization to 3PL service provider for products manufactured outside of the US.
- Support Drug Product Complaint management; forwarding to respective drug product manufacturing site and coordinate with corporate QA for investigations.
- Support Drug Product Recall/Field alert management.
- Assist with review of Quality Agreements.
- For applicable products, coordinate with Contract Testing Laboratories for Analytical Method Transfer activities, Drug Product testing, any OOS results, and test method issues.
- With supervision, review deviations/investigations related to Strides Pharma Inc. (Strides) frontend products.
- Assist with SOP management for Strides’ US corporate office.
- Support with quality matters for disposition of product returns.
- Assist during FDA inspections and local regulatory inspections at Strides’ US corporate office.
Job-Specific Requirements - Excellent verbal and written communication skills are necessary.
- With supervision and direction, effectively prioritizes competing tasks in a fast-paced and dynamic environment.
- Motivated, results driven with attention to detail, accuracy and clarity.
Qualifications - BS degree in Pharmacy, Chemistry, Biology or Microbiology is preferred. 1-2 years of Quality Assurance or related pharmaceutical industry experience is preferred. Recent graduates will be considered for this role.
Job Tags
Contract work, Local area,