Title: Manager, Quality Assurance
Company Name: Genvio Pharma Limited
Job Location: Mymensingh (Trishal)
Employment Status: Full-time
∎ B. Pharm / M. Pharm from any reputed University.
∎ 8 to 10 year(s)
∎ 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
∎ Age 35 to 38 years
∎ 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)
Compensation & Other Benefits:
∎ As per company policy
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 6 Oct 2022
∎ 7 Sep 2022
∎ Genvio Pharma Limited
: Only males are allowed to apply