Silva Pharmaceuticals Ltd.

Assistant Manager, Quality Assurance

General Info
  • Published on: Aug 01, 2019
  • Deadline: Aug 31, 2019
  • Source: bdjobs.com
  • Vacancy: 1
Job Details
  • Job Nature: Full-Time
  • Job Location: Noakhali
  • Salary: Negotiable
  • Job Description:
    • The major job is to establish procedures and quality standard and to monitor these against agreed target of the organization.
    • Independently manages review and approval of master batch records, labels, specifications, and other manufacturing documents of clinical and commercial drug substances and drug products in compliance with all applicable requirements.
    • Independently manages review and approval of executed manufacturing records, analytical data, and associated documentation, including deviations and investigation reports related to production and disposition.
    • Leads, trains others and approves Quality investigations.
    • Leads the review and approval of change control requests to ensure compliance with all applicable requirements.
    • Lead QA representative, including compliance responsibility, on the internal Silva team.
    • Leads and trains others in internal audit and vendor management programs.
    • Prepares and presents quality metrics.
    • Independently initiates and approves SOP updates and creation of new SOPs. Additionally, oversees review of SOPs and associated documentation to ensure biennial review requirements are met.
    • Lead Quality representatives for regulatory inspections.
    • Lead establishment of Quality-specific documents (e.g., Quality Risk Management Plan, Quality Agreements, Site Master File, and Validation Master Plan).
    • Ensure Quality processes at PCYC and across the supply chain comply with all applicable regulations and guidelines.
    • If this position has direct reports:
    • Provide technical guidance and timely performance feedback through routine 1:1 meetings.
    • Provide technical development through OTJ training.
    • Work with HR to ensure opportunities for professional development.
    • Assist with developing individual goals and objectives.
    • Ensure that all quality and regulatory requirements (as per cGMPs, ICH and ISO 9001 standard) is effective, implemented and continuously improving for all products and processes.
    • Ensure that concerned personnel of the organization are trained in relation to Quality Management System Requirements
    • Develop and maintain internal audit program and standing systems, which deal with nonconforming product (NCR), customer inquires (CI), corrective and preventive actions (CAPA), track and monitor these actions until closure.
    • Acts as a quality liason with regulatory authorities and external auditors during inspections.
    • Schedule and conduct Management Review Meeting as required by ISO 9001 standard.
    • Prepare detailed summary reports, review data, analyze trends, and drive corrective actions for significant issues.
    • Additional duties as assigned.
  • Compensation & Other Benefits:
    • T/A, Mobile bill, Tour allowance, Medical allowance, Provident fund, Gratuity
    • Lunch Facilities: Full Subsidize
    • Salary Review: Yearly
    • Festival Bonus: 2
    • As per the Company rules
Job Requirements
  • Age Specification: 30 to 40 years
  • Educational Requirements:
    • Master of Pharmacy (M.Pharm)
    • Skills Required: Compliance, Computer skill, Documentation, Excellent communication skill
  • Experience Requirements:
    • At least 7 year(s)
    • The applicants should have experience in the following area(s): Quality Controller/ Assurance
    • The applicants should have experience in the following business area(s): Pharmaceuticals
  • Additional Requirements:
    • Must have the A-Grade Registration of Bangladesh Pharmacy Council (BPC)
    • Excellent working knowledge of global GMP regulations, ICH guidelines and robust Quality Systems.
    • Broad experience in the pharmaceutical industry with a strong analytical and/or manufacturing background.
    • Detail oriented with demonstrated problem solving acumen.
    • Ability to work effectively in a team environment with great organization skills.
    • Ability to independently analyze and reconcile complex issues.
    • Must be an individual with proven initiative and accountability
    • Must be able to lead in a fast paced environment.
    • Excellent verbal and written communication and interpersonal skills.
    • Proficient with computers and typical office software (i.e., Microsoft Office products).
Apply Procedure
  • Apply Instructions: Apply with an updated CV and recent passport size color photograph addressing Head of HR, Silva Pharmaceuticals Limited, House # 65, Road # 8/A (New), Dhanmondi, Dhaka-1209 mentioning the position applying for on top of the envelope or in the subject field of e-mail attachment. Photograph must be enclosed with the resume
  • Apply Link: Apply Online