Dr Reddy’s Chemistry Associate Quality-Batch Release Position – Apply Now
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 based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.
Job Description:
We have an opening for an Associate, Quality-Batch Release/Ops, to support our Princeton, NJ office. The incumbent will be based in India and report to the Lead, Quality Operations/Batch Release – North America. This quality role will be responsible for supporting the batch release group in record reviewing and batch release of products to the US market. This role involves the review of Quality Control, manufacturing, packaging, Temperature data review, and Quality Assurance records to assure compliance with CGMPs that meet company goals and FDA expectations.
Roles & Responsibilities:
- Responsible for QA oversight of 3PL distribution centers and inventory management.
- Batch record review and batch release of products involve the critical, independent review of Quality Control, manufacturing, packaging, and Quality Assurance records.
- Adhere to standards to ensure compliance with CGMP’s and FDA expectations.
- Support and interface with customer service teams to provide customer requests for COAs and other documentation.
- Manage Quality secondary reconciliation updates in the DEA controlled substances import management system.
- Identifies trends and potential compliance gaps and drives quality improvement initiatives of the batch release team by tracking and trending Quality metrics.
- Any other assigned activities.
Qualifications
Educational Qualification: An advanced degree in chemistry, organic chemistry, biochemistry, or a similar discipline is required.
Minimum Work Experience: 2 to 4 years of experience working in a cGMP Quality role is required.
Skills & attributes:
Technical Skills:
- Experience in Quality Assurance (QA) domain.
- Sound knowledge of CGMP and ICH regulations.
- Due diligence experience.
- Strong working knowledge of Microsoft Office (Excel, Word, PowerPoint, etc.) is required. Experience in ERP and QMS systems is a plus.
Behavioral Skills:
- Excellent communication and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Good negotiation and influencing skills.
- Ability to work collaboratively with cross-functional teams across US – India time zones.
Apply for the position here
Keywords: Associate, Quality-Batch Release/Ops, Dr. Reddy’s Laboratories Ltd., Quality Assurance, CGMP, FDA regulations. Dr Reddy’s Chemistry Associate Quality-Batch Release Position – Apply Now. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
