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Aseptic Sterility Assurance Manager

Department: Production

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ABOUT GLENMARK:

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), 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:

Under the direction of the Senior Director of Operations, the Aseptic Sterility Assurance Manager is responsible for the overall aseptic health and compliance of the aseptic processes, the pharmaceutical elegance of the cleanroom area and oversight of the aseptic technique of all personnel and operations in the aseptic manufacturing area. This position will have ownership of the media fill program including generation of the media fill protocol, scheduling, execution, oversight of the media fills, completion of the media fill batch record, completion of the media fill run summary, audit responses including internal, 3rd party and regulatory audit response items. In addition, this individual will own oversight of the daily room checklist program to maintain the aseptic area in a state of audit readiness. This individual will be an aseptic subject matter expert and work with cross function groups to plan future project and site expansion.

OVERALL JOB RESPONSIBILITIES:

Area Aseptic oversight:

Subject matter expert for aseptic process, personnel technique for operations and support groups, gowning, area aseptic elegance/readiness. Work with investigator and operations management for a complete and robust investigation with appropriate holistic and global CAPAs/Action Items to drive process and continuous improvement initiatives.

Internal Audit:

Schedule, execute internal audits for assessment of review of aseptic technique, process assessment to determine proper interventions and intervention technique, gowning assessment including technique and gowning materials.

Media Fill Program:

Own the media fill program which includes scheduling, media fill protocol generation, batch record review/completion, intervention assessment and media fill run summary completion.

Audits and Inspections:

Support audits / inspection processes, including, but not limited to: governmental, regulatory, Corporate audits and audit readiness related activities. Support external/regulatory audits / inspections when required.

KNOWLEDGE, SKILLS AND ABILITIES:

Education :

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

Experience:

Minimum 5 years in Operations or Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry, or a combination of education and experience.

Knowledge and Skills :

Strong understanding of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical industry primarily aseptic manufacturing.

Must be proactive, results-oriented with a strong attention to detail and strong 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 ability to interact with all levels of personnel in a professional manner.

Intermediate Excel and/or Minitab skills are required including, but not limited to: spreadsheet manipulation, charting, and analysis tools.

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