Veritas Pharmaceuticals Ltd.

Manager - Quality Assurance

General Info
  • Published on: Jun 07, 2018
  • Deadline: Jul 05, 2018
  • Source: Bdjobs.com
  • Vacancy: 1
Job Details
  • Job Nature: Full-Time
  • Job Location: Gazipur
  • Salary: Negotiable
  • Job Context: The position is directly report to Vice Chairman & CEO and have required sufficient experience of Factory management and is responsible for managing QA and QC operations of the Company which include providing periodic QA and QC reports, maintenance of an adequate system of QA and QC records, designing and control system to mitigate risk as well as to enhance the accuracy of the company`s reported QC effective results. The position is also responsible to ensure that reported results comply with generally competitive market.
  • Job Description:
    • Supervising a team of QC staff supporting operations in equipment life cycle and maintenance, analytical method life cycle and maintenance, quality systems and stability program
    • Ensure that suitable written records and work undertaken are kept in accord with cGMP
    • Manage qualifications, validations and transfers of analytical methods in accordance with applicable policies or guidelines from Analytical Development to Quality Control.
    • Maintaining regulatory guidelines, cGMP guideline, Environmental Health and Safety regulations as required by the job function
    • Write technical reports or documentation such as deviation reports, testing protocols, and trend analysis.
    • Review and compile laboratory test data and perform analysis.
    • Monitors raw material testing equipment and instrument qualification, calibration, and preventive maintenance, as assigned.
    • Execute all laboratory investigations.
    • Review and investigate all laboratory data outside of trend OOT/OOS.
    • Review protocols and reports such as method validation, method transfer, process validation and stability.
    • Ensure all vendors have been qualified and adhere to vendor qualification standards with the aim of optimal utilization of the reduced testing procedure.
    • Establish and implement a KPI structure to ensure optimal test / cost ratio.
    • Organize and supervise cleaning validation activities.
    • Carry out specification settings and impurity evaluation of raw material and finished products.
    • Comparative dissolution profile study and all analytical support to all regulatory authorities.
    • Implementation and maintenance of GLP in quality control area.
    • Performs other duties as assigned in support of QC Laboratory operations such as facilities qualification and routine.
    • Monitoring testing, as well as QC testing, data reviews, sampling, and maintaining QC laboratory systems, when appropriately trained and qualified.
Job Requirements
  • Age Specification: Age 35 to 48 years
  • Educational Requirements:
    • The candidate should be post-graduate with very good academic records in Pharmacy/ Chemistry or Bio-Chemistry.
    • Minimum CGPA 3.00 out of 4.00 but no third division or equivalent CGPA at any level acceptabl
  • Experience Requirements:
    • 10 to 20 year(s)
    • The applicants should have experience in the following area(s): Pharmacist, Micro-Biologist, Bio-Chemist/ Chemist, Quality Controller/ Assurance
    • The applicants should have experience in the following business area(s): Pharmaceuticals
  • Additional Requirements:
    • Both males and females are allowed to apply
    • Over all supervision of Q.C activities, Analytical Method Development / Equipment Validation, Calibration.
    • To develop Validation Master Plan (VMP) / Validation Protocol / IQ / OQ / PQ / document.
    • Also coordinate all validation activities.
    • To ensure all activities related to Production, Quality Control and Storage are in compliance with the guideline of cGMP.
    • Proven ability to work effectively both independently and in a team based environment.
    • Strong multi-tasking and organizational skills.
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