Dr Reddy’s Labs Associate Job For Biochem – Apply Online
Associate, Quality-Batch Release/Ops
Location: Hyderabad, Telangana, India
About the job
Company Description
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company with a global presence. Every day, over 24,000 employees contribute to accelerating access to affordable and innovative medicines, driven by the purpose that “Good Health Can’t Wait.”
Job Description
We are looking for an Associate, Quality-Batch Release/Ops to support our Princeton, NJ office. This India-based role reports to the Lead of Quality Operations/Batch Release – North America. The position will involve supporting the batch release team through record review and batch release of products for the US market, ensuring compliance with CGMPs and FDA standards. Responsibilities include the review of Quality Control, manufacturing, packaging, temperature data, and Quality Assurance records.
Roles & Responsibilities
- Provide QA oversight of 3PL distribution centers and manage inventory.
- Conduct batch record reviews and batch release of products, involving an independent review of Quality Control, manufacturing, packaging, and Quality Assurance records.
- Ensure adherence to CGMP standards and FDA expectations.
- Support customer service teams by providing customer-requested documentation, including COAs.
- Manage secondary reconciliation updates in the DEA-controlled substances import management system.
- Identify trends and potential compliance gaps, tracking and trending Quality metrics to drive improvement initiatives.
- Perform other assigned activities as needed.
Qualifications
Educational Qualification:
- Advanced degree in chemistry, organic chemistry, biochemistry, or a related field.
Minimum Work Experience:
- 2 to 4 years of experience in a cGMP Quality role.
Skills & Attributes
Technical Skills:
- Experience in Quality Assurance (QA).
- Strong knowledge of CGMP and ICH regulations.
- Due diligence experience.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint, etc.); experience with ERP and QMS systems is an advantage.
Behavioral Skills:
- Excellent communication and interpersonal skills.
- Strong analytical and problem-solving skills.
- Effective negotiation and influencing abilities.
- Ability to work collaboratively with cross-functional teams across US-India time zones.
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