• Senior Quality Assurance Associate

    Location US-NJ-Bridgewater
    Posted Date 2 weeks ago(1/4/2019 10:21 AM)
    Kashiv Pharma LLC
  • Overview

    The Senior Quality Assurance Associate for Kashiv is responsible for oversight and monitoring of quality systems ensuring that operations are conducted in accordance with current Good Manufacturing Practice. This position is 8:30am-5:30pm Monday-Friday at our Bridgewater, NJ location.


    Essential Duties & 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 and Participate in 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
    • Prepare and execute Quality meetings on regular basis


    Position Requirements and Qualifications


    • Bachelors Degree in Science (required); Preferably in Pharmaceutical Sciences or Technology, Chemical Engineering, etc.
    • Minimum of 5 – 10 years of 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.


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