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.
QUALIFICATIONS
Education & Experience
- Bachelor’s degree in Pharmacy, Chemistry, Biology or Microbiology is preferred
- 1 to 2 years of Quality Assurance or related pharmaceutical industry experience is preferred. Recent graduates will be considered for this role.
Knowledge & Skills
- 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.
Physical Requirements
- General Office environment