Lead Associate, Quality-Batch Release/Ops - Hyderabad, India - Dr Reddy's Laboratories Limited

Description

We have an opening for a Lead 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.
• Provide for-cause, due diligence, and general GMP audits of contract manufacturers in India supporting NAG business unit and incorporate risks identified during monitoring strategy.
• Any other assigned activities

Educational Qualification:

• An advanced degree in chemistry, organic chemistry, biochemistry, or a similar discipline is required.

Minimum Work Experience

• 6 to 8 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.

Our Work Culture
Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't 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 we're 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