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,

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