Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.

Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, and Brazil.

Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research–based pharmaceutical company.

Position Summary:

The Quality Assurance Batch Record Reviewer is primarily responsible for:

• Collaborating with Manufacturing Operations for compliance with current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs)
• Promptly and accurately reviewing batch production records (BPRs), Quality Control records, and all logs to determine compliance with Good Manufacturing Practices, Good Documentation Practices, and established company procedures.

Major Functions and Responsibilities:

• Promptly and accurately review manufacturing batch records and identify product records that do not meet product release requirements.
• Identify and resolve batch record documentation errors in a timely manner
• Support change control, deviation, issue, incident, investigation and CAPA related to batch manufacturing
• Support quality system improvements
• Prepare release labels for manufacturing and packaging operations
• Review laboratory data for completeness and compliance to specifications
• Archive all manufacturing records, quality control records, and logs once products are released
• Review certificates of analysis, certificates of conformance, etc
• Release all products that meet specification requirements manufactured onsite
• Provide support during regulatory and other audit-related activities
• Assist in the data collection, summary preparation and submission of periodic metrics
• Perform other duties as assigned by Director of the department

Required Education / Work Experience:

• Minimum 3-5 years of experience in a cGMP regulated environment (pharmaceutical, medical device etc)
• Bachelor’s Degree or equivalent work experience
• Prior batch record review experience is required
• Microbiology and/or Chemistry experience is preferred
• Manufacturing and/or Operations experience is preferred
• Ability to work directly with manufacturing under limited supervision is required

Other Skills and Abilities:

• Self-starter, motivated individual with high level of attention to detail
• Able to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demands
• Strong interpersonal skills and ability to work with all levels of the organization
• Strong problem solving ability. Ability to clearly express ideas (verbal and written) ability to translate verbal and written instructions
• Demonstrated knowledge of computer and quality management systems and Microsoft office skills required