Manager, Quality Assurance

Job Description

Title: Manager, Quality Assurance

Company Name: Genvio Pharma Limited

Vacancy: 1

Job Location: Mymensingh (Trishal)

Employment Status: Full-time

Educational Requirements:
∎ B. Pharm / M. Pharm from any reputed University.

Experience Requirements:
∎ 8 to 10 year(s)

Job Responsibilities:
∎ 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

Additional Requirements:
∎ 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)

Salary: Negotiable

Compensation & Other Benefits:
∎ As per company policy

Job Source: Online Job Posting.

Application Deadline: 6 Oct 2022

Company Information:
∎ 7 Sep 2022
∎ Genvio Pharma Limited

Category: Medical/Pharma

: Only males are allowed to apply

Similar Jobs

Medical Promotion Officer

Medical Technologist/Phlebotomist (Sample Collector) - Laboratory/Radiology & Imaging

Pharmacist / In-charge

Junior Executive - Pharma Telesales

Senior Executive - Quality Assurance

Depot In Charge, Distribution Division

Executive - Quality Assurance

Medical Coordinator, Medical Services Department

Nutritionist (for Call Center)

Medical Assistant

Dental Technologist (Shariatpur)

Bangla Job

Bangla Job

Bangla Job

Bangla Job

Bangla Job

Bangla Job

Bangla Job

MBBS/ BUMS Doctor (Scholarship Opportunity)

Bangla Job

Bangla Job

Clinical Mentor- Female

Medical Officer - Female

Sr. Executive/ Executive - PMD

Dental Technologist (Diploma)

Bangla Job

Bangla Job

Hospital Supervisor

Acupuncturist cum Acupotomy

Medical Officer

Executive/ Sr. Executive, Microbiology

Bangla Job

Hospital Supervisor (Housekeeping)

Hospital Supervisor

Brand Executive

Dental Surgeon

Senior Staff Nurse

Marketing Promotion Officer

Bangla Job

Bangla Job