Glenmark Pharmaceuticals Inc., USA, is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules—both New Chemical Entities (NCEs) and New Biological Entities (NBEs). Eight molecules are 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. The USA subsidiary also markets APIs to regulated and semi-regulated countries.

POSITION SUMMARY:

Under the crucial direction of the Head of Operations and the Head of Quality Systems, the Deviation Investigator will play a pivotal role in our company's growth by owning and investigating all Manufacturing-related deviations. The Deviation Investigator will collaborate with cross-functional stakeholders to perform simple and complex root cause analyses, identifying corrective actions to close assigned investigations on time.

The role will support all aspects of the Dispensing, Compounding, Sterilization, Terminal Sterilization, Lyophilization, aseptic syringe filling, aseptic vial filling, visual inspection, and packaging. The philosophy in Monroe is to become a best-in-class aseptic manufacturing facility.

This individual will be part of a supportive work environment, closely collaborating with cross-functional teams at the site and abroad. They will routinely report on quality system and business process performance, proactively identifying, providing guidance, and implementing process and system improvements to resolve complex issues promptly, ensuring a smooth and efficient work process.

JOB RESPONSIBILITIES:

• Ensures investigations are logged, triaged, investigated, and resolved according to established deadlines and company and regulatory requirements.
• Coordinates with cross-functional teams for testing of reserved or retained samples for investigation purposes, where applicable.
• Coordinates the reviews of relevant records (e.g., batch records, quality control data, quality investigations, etc.)
• Conducts root cause analysis to facilitate and initiate corrective and preventative actions wherever needed.
• Tracks quality system metrics and creates detailed trend analysis reports.
• Performs analysis of data, trending, and provides metrics for Quality Systems, as required.
• Ensure Quality Systems comply with CGMPs and internal/external regulations and procedures.
• Supports implementation of projects that improve site Quality and efficiency.
• Assess changes in terms of their impact on CGMP and use risk management tools.
• Prepares and compiles the required data to support the APR submission for the products manufactured on-site.
• Management of multiple investigations concurrently
• Provide routine updates to communicate status and alignment on investigation findings.
• Ability to communicate roadblocks and challenges promptly that can impact tasks and timely investigation delivery.
• Provide guidance and work with stakeholders from various departments to process Investigations, CAPA, Change Controls, and Deviations.
• Trains and guides individuals on processing Quality Events, Deviations, and CAPAs effectively and efficiently.
• Holds cross-functional meetings to discuss root cause analysis of investigations and quality events.
• Track and trend events/deviations
• Develop/author quality SOPs and related documents as needed
• Perform quality review of documentation and processes
• Provide trend reports of quality events
• Ability to convince individuals of the minimum requirements for investigations.
• Excellent Interpersonal skills.
• Communication Proficiency
• Decision Making
• Detail Oriented
• Problem Solving/Analysis
• Quality
• Results Driven
• Technical Capacity

Education:

Bachelor of Science (BS) / Bachelor of Arts (BA) in Science, Engineering, Pharmaceutical Sciences, or equivalent

Experience:

Minimum three years in Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry or a combination of education and experience.

Knowledge and Skills (Functional / Technical):

• Strong understanding of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.) related to the pharmaceutical industry.
• Must be proactive and results-oriented with a strong attention to detail and time management skills.
• Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced, critical work environment.
• Ability to analyze details and perform structured decision-making on a daily basis.
• Excellent verbal and written communication/documentation skills. Must be able to read, write, and speak English.
• Strong interpersonal skills with the ability to interact professionally with all personnel levels.
• Experience utilizing root causes analysis tools and identifying corrective and preventative actions is required.
• Prior experience in the manufacturing environment or troubleshooting manufacturing-related issues is preferred.
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks.
• Ability to work well on a team.
• Ability to function well in a high-paced and, at times, stressful environment.
• Ensures accuracy and relevance of assigned training curriculum.
• Drives timely completion of training for employees to meet regulatory requirements
• The ability to work independently or within a team structure on multiple projects and be flexible enough to adapt to changing priorities is required.
• Self-starter with the ability to work independently with minimum supervision and use good judgment or as a contributing member of a team.
• Any quality or lean/Six Sigma certifications are a plus.