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Associate, Quality-Batch Release/Ops

2-4 years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: Advanced degree in Chemistry, Organic Chemistry, Biochemistry, or a similar discipline. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate, Quality-Batch Release/Ops

Company: Dr. Reddy’s Laboratories Ltd.

Location: Princeton, NJ (Incumbent based in India)

About Dr. Reddy’s Laboratories: Dr. Reddy’s Laboratories is a global leader in the pharmaceutical industry, committed to making affordable and innovative medicines accessible worldwide. With a presence in 66 countries and a mission to reach over 1.5 billion patients by 2030, we focus on sustainability, integrity, and creating value for stakeholders. We foster a work environment free from discrimination and encourage a diverse, inclusive workforce.

Job Description: Dr. Reddy’s is seeking an Associate, Quality-Batch Release/Ops to support the batch release group for products sold in the US market. This role involves reviewing critical records, ensuring compliance with CGMPs, and supporting various operational aspects related to quality assurance in the batch release process.

Key Responsibilities:

  • Provide QA oversight for 3PL distribution centers and manage inventory.
  • Perform batch record reviews and release products by evaluating Quality Control, manufacturing, packaging, and Quality Assurance records.
  • Ensure compliance with CGMPs and FDA regulations for batch release.
  • Support customer service teams with requests for Certificates of Analysis (COAs) and other documentation.
  • Manage Quality secondary reconciliation updates within the DEA-controlled substances import management system.
  • Identify trends and potential compliance gaps, driving quality improvements within the batch release team by tracking and trending quality metrics.
  • Assist with other assigned activities to support quality assurance processes.

Qualifications:

  • Educational Qualification: Advanced degree in Chemistry, Organic Chemistry, Biochemistry, or a similar discipline.
  • Work Experience: 2-4 years of experience in a cGMP Quality role.

Skills & Attributes:

  • Technical Skills:
    • Experience in the Quality Assurance (QA) domain.
    • Strong knowledge of CGMP and ICH regulations.
    • Due diligence experience is preferred.
    • Proficiency in Microsoft Office (Excel, Word, PowerPoint), ERP, and QMS systems.
  • Behavioral Skills:
    • Excellent communication and interpersonal skills.
    • Strong analytical and problem-solving abilities.
    • Negotiation and influencing skills.
    • Ability to collaborate effectively across time zones (US and India).

Additional Information:

Dr. Reddy’s Laboratories values a culture of empathy, teamwork, and shared success. Our employees are motivated by the company's commitment to providing healthcare solutions that improve patients' lives. We believe that our people make magic happen when bound by a common purpose and value system.

For more details about this role and to apply, visit our career website.