Genvio Pharma Ltd.

Manager, Quality Assurance

General Info
  • Published on: Sep 07, 2022
  • Deadline: Oct 06, 2022
  • Source:
  • Vacancy: 1
Job Details
  • Job Nature: Full-Time
  • Job Location: Bagan, Trishal , Mymenshigh
  • Salary: Negotiable
  • Job Description:
    • Evaluate quality system processes recommend improvements in compliance with regulatory requirements.
    • Engage and align with other diverse and dispersed organizations and functions, building teamwork.
    • Partners with others and leads and motivates an organization in driving continuous improvement and change, improving customer satisfaction.
    • Provide support during regulatory inspections and client audits as applicable
    • Provides inspection readiness support to the site -identification of compliance gaps and risks, and participation in the remediation process.
    • Participate in inspection preparation, and participate in regulatory inspections, defending Deviation/CAPA policies and practices.
    • Ensure a proactive determination of regulatory, compliance and quality issues and integrates them into audits/assessments on a priority basis.
    • Develop Deviation/CAPA policies, and continuously evaluate and improve practices and systems to coordinate with validation, documentation, and regulatory systems related to Deviation/CAPAs.
    • Strive toward constant improvement of systems in order to maintain compliance cGMP requirements for work performed.
    • Manage product complaints for commercial and clinical investigational products.
    • Interaction with customers through management during complaint process and audits.
    • Identify gaps in complaint handling /deviation /CAPA process as it relates to reporting, metric, and trending to maintain seamless compliance and develop feasible plans for correction.
    • Author Annual Product Reviews
    • Possesses regulatory and business knowledge to champion improvements to the quality systems.
    • Integrate risk management with current and emerging processes.
    • Author and/or review and implement SOPs to ensure compliance with current Halo standards and cGMP
    • Responsible for evaluating product failures and generating the evaluation report.
    • Responsible for working with R&D and manufacturing to develop validation protocols for production processes, and generating the final report covering the validation results and a recommendation for approval or disapproval for the release of the process to manufacturing.
    • Conduct internal audits and coordinate and manage external ISO audit schedules, correspondence and closing of findings
    • Responsible for quality control and a quality system for SMP’s products and products that we are the legal manufacturer
    • Responsible for reviewing and establishing the company quality goals each year.
    • Establish an export compliance system
  • Compensation & Other Benefits: As per company policy
Job Requirements
  • Age Specification: 35 to 38 years
  • Educational Requirements: B. Pharm / M. Pharm from any reputed University.
  • Experience Requirements: 8 to 10 year(s)
  • Additional Requirements:
    • Only males are allowed to apply
    • Strong knowledge of cGMPs and have 8-10 years’ experience.
    • 4-5 years of experience as a Manager, QA.
    • Communication- Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Writes clearly and informatively; Presents numerical data effectively
    • Leadership- Exhibits confidence in self and others; Inspires and motivates others to perform well; Accountable for behaviors and their impact on others; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others
    • Strategic Thinking – Develops strategies to achieve organizational goals; Understands organization’s strengths & weaknesses; Adapts strategy to changing conditions. Critically evaluates quality systems to propose best practices.
    • Computer skills: MS Office (Word, Excel, PowerPoint and Access)
Apply Procedure
  • Apply Instructions: Only males are allowed to apply. The photograph must be enclosed with the resume. Send your CV to