• AQA Specialist (Stability Coordinator)

    Glenmark Pharmaceuticals Inc., USA (Monroe, NC)


    AQA Specialist (Stability Coordinator)

     

    Department: Analytical QA

     

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    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 Analytical Quality Assurance Specialist (Stability Coordinator) mainly supports the management of the stability program and sample management in coordination with QC Laboratory for all ANDA and NDA products. Support includes but is not limited to the following: Preparing stability protocol, verification of sampling plan, receiving and charging of stability samples, preparing labels indicating charge-in dates, pull dates, intervals and storage conditions that are to be applied on these samples, affix labels and distribute samples to appropriate storage conditions as identified in approved stability protocols, maintains sample log residing in the stability storage area and initiates stability studies in the system as and when required. This role also manages distribution and pull of stability samples to and from designated stability storage. This role can be expanded to other AQA functions as and when needed to help in programs developed to provide AQA oversight for laboratories including but not limited to test data review and retain sample management for materials and finished product.

    OVERALL JOB RESPONSIBILITIES:

    Financial:

    + Ensures all stability reports and associated data are prepared and timely to support Regulatory on all ANDA and NDA filings.

    Operational Excellence:

    + Pulls stability samples at the appropriate dates following stability protocol and stability planner.

    + Submitting samples to QC per schedule

    + Maintains accurate records of stability samples. Coordinates stability testing activities per stability protocol.

    + Review stability study analytical reports, stability reports and OOS/OOT investigation if reported

    + Maintains the stability chamber temperature and humidity logging system.

    + Coordinates in-house testing of Special Request samples and provides feedback and follow-up of lab testing.

    + Supports efforts to maintain stability chambers in a ready state of compliance for internal and external audits.

    + To provide authorization for destruction of the stability samples after completion/discontinuation of stability study

    + Help in managing walkthroughs and periodic review of analytical laboratories and data review for raw materials and finished products.

    + Manage retain samples for raw materials and finished product

    Stakeholder:

    + Provides timely stability summaries and stability reports to stakeholders that includes data trends.

    + Maintains stability chambers in a state of qualification, calibration, and preventive maintenance .

    + Inform CQA, RA and R&D in case of significant change/OOS in stability study

    Innovation:

    + Maintains stability calendars and stability database.

    KNOWLEDGE, SKILLS AND ABILITIES:

    Education :

    + Bachelor-s degree in Chemistry, or closely related scientific discipline.

    + Degree in Chemistry is highly preferred.

    Experience:

    + 2 - 4 years in the field of Pharmaceutical manufacturing facility with background in the functional area of Quality Control stability and finished product testing.

    + Experience in stability program coordination or interpretation of stability data is a plus.

    Knowledge and Skills :

    + Knowledge of current cGMP regulations for laboratory and ICH guidelines relevant for the stability area . SAP experience is preferable.

    + Proficient in Windows, Microsoft Word, Excel.

    + Good written, verbal, and communication skills.

    + Good documentation skills.

    + Strong organizational skills.

    + Time management

     

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