• Sr QA Associate

    Location US-NJ-Bridgewater
    Posted Date 2 weeks ago(5/7/2018 3:31 PM)
    ID
    2018-2156
    Company
    Kashiv Pharma LLC.
  • Overview

    Kashiv Pharma, LLC. is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. Kashiv also offers contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture.

     

    The Senior Quality Assurance Associate is responsible for oversight and monitoring of quality systems ensuring that operations are conducted in accordance with current Good Manufacturing Practice.

    Responsibilities

    Key responsibilities of the position include, but are not limited to –

     

    • Responsible for the oversight, reporting and monitoring of company's quality systems, including investigations, corrective actions (CAPA), training programs.
    • Responsible for the improvement of existing systems and the development of new quality systems.
    • Assist all departments in the generation of quality system documentation; such as, SOPs, deviation/investigation reports, equipment/system qualification protocols and reports, and change controls.
    • Quality release of raw materials and finished products.
    • Coordinate quality investigations (including OOS investigations); work with impacted functions in the development of required CAPA items.
    • Coordinate submission of samples for QC analysis.
    • Administration of Kashiv stability program – protocol review, stability set-up, environmental chamber monitoring, etc.
    • Administration of Kashiv change control system.
    • Review and approval of manufacturing and packaging master and executed batch records.
    • Provide QA support during manufacturing and analytical operations.
    • Audits: Perform internal and external (vendors/facilities) audits.
    • Interface with customers to resolve quality issues.
    • Performs other functions as required or assigned
    • Complies with all company policies and standards

    Qualifications

    • Bachelors Degree in Science (required); Preferably in Pharmaceutical Sciences or Technology, Chemical Engineering, etc.
    • Minimum of 6 to 10 years relevant experience in a pharmaceutical quality assurance/control environment.
    • Experience of GMP document review, Quality Management System maintenance, quality auditing.
    • Understand the requirements and procedures related to document control and Quality Assurance.
    • SOP and Deviation Investigation preparation literate
    • Provides support to multiple stakeholders. Requires the ability to understand and discuss GMP issues with the customer, and work to address the same.
    • Ability to work with teams and independently - good interpersonal skills.
    • Excellent communication skills: verbal, written and presentation.
    • Organization and time management skills, detail oriented. Generally requires independent discretion in execution and ability to meet deadlines.
    • Good computer skills, including in depth knowledge of Word, Excel and spread sheet software required.
    • Knowledgeable in GMP aspects of the Pharma industry is required.

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