Associate Quality-Batch ReleaseOps
Associate Quality-Batch ReleaseOps
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Job Description
We have an opening for a Associate QualityBatch 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 CGMPs 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 problemsolving abilities.
- Good Negotiation and Influencing skills.
- Ability to work collaboratively with crossfunctional teams across US India time zones.
Additional Information :
Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
