Genvio Pharma Ltd.
Manager, Quality Assurance
- Published on: Sep 07, 2022
- Deadline: Oct 06, 2022
- Source: Bdjobs.com
- Vacancy: 1
- Job Nature: Full-Time
- Job Location: Bagan, Trishal , Mymenshigh
- Salary: Negotiable
- 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
- Age Specification: 35 to 38 years
- Educational Requirements: B. Pharm / M. Pharm from any reputed University.
- Experience Requirements: 8 to 10 year(s)
- 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 Instructions: Only males are allowed to apply. The photograph must be enclosed with the resume. Send your CV to firstname.lastname@example.org.