Quality Assurance (QA) Manager

Job Description

Title: Quality Assurance (QA) Manager

Company Name: AIkad Laboratories

Vacancy: --

Location: Rangpur (Rangpur Sadar)

Minimum Salary: Negotiable

Experience:
∎ At least 10 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies

Published: 10 Apr 2025

Education:
∎ Master of Pharmacy (M.Pharm)
∎ MPharm from a reputed university with registration.

Requirements:

Additional Requirements:
∎ Minimum 10 years of experience in Quality Assurance within the pharmaceutical industry.
∎ Proven track record of successfully managing QA teams and implementing quality management systems.
∎ Strong understanding of GMP, GLP, and other regulatory standards.
∎ Excellent communication, analytical, and problem-solving skills.
∎ Ability to work under pressure and meet deadlines effectively.

Responsibilities & Context:
∎ 1. Quality System Management:
∎ Develop, implement, and continuously improve Quality Assurance Systems (QAS) in line with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory requirements.
∎ Design, update, and enforce Standard Operating Procedures (SOPs) for all manufacturing processes and quality control operations.
∎ Ensure adherence to established QMS policies across all production and quality control units.
∎ 2. Auditing & Compliance:
∎ Plan, conduct, and oversee internal and external audits to evaluate compliance with regulatory standards and company policies.
∎ Prepare for and facilitate regulatory inspections from government agencies and certification bodies, ensuring successful outcomes.
∎ Implement Corrective and Preventive Action (CAPA) plans based on audit findings to strengthen quality systems.
∎ 3. Product Quality Control:
∎ Ensure quality standards are maintained throughout the manufacturing process, from raw material inspection to finished product release.
∎ Review and approve batch records, validation reports, and other documentation to ensure accuracy and compliance.
∎ Perform Root Cause Analysis (RCA) for deviations and implement corrective actions to prevent recurrence.
∎ 4. Risk Management & Validation:
∎ Identify potential quality risks and develop mitigation strategies to maintain product integrity.
∎ Oversee validation processes for equipment, manufacturing processes, cleaning, and packaging to ensure consistent quality.
∎ 5. Documentation & Reporting:
∎ • Maintain accurate and up-to-date quality assurance records, including audits, inspections, validations, and SOPs.
∎ Prepare detailed quality reports for senior management and regulatory authorities.
∎ Ensure timely submission of documentation required for regulatory approvals and certifications.
∎ 6. Training & Leadership:
∎ Lead, mentor, and guide the QA team, promoting a culture of continuous improvement and excellence.
∎ Conduct regular training sessions for staff on GMP, GLP, SOPs, and regulatory standards.
∎ Encourage teamwork and collaboration across departments to ensure adherence to quality standards.
∎ 7. Collaboration & Continuous Improvement:
∎ Work closely with Production, PD, and Regulatory Affairs teams to enhance quality processes.
∎ Monitor industry trends, technological advancements, and regulatory updates to maintain the highest standards.
∎ Develop and implement strategies for continuous improvement in quality systems and processes.
∎ 8. Customer Complaint Handling:
∎ Investigate and resolve quality-related complaints from customers with thorough root cause analysis.
∎ Implement measures to prevent recurrence and enhance overall product quality.
∎ As a Quality Assurance (QA) Manager, you will be responsible for developing, implementing, and managing the quality assurance systems to ensure the highest product standards. Your duties will include:
∎ 1. Quality System Management:
∎ Develop, implement, and continuously improve Quality Assurance Systems (QAS) in line with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory requirements.
∎ Design, update, and enforce Standard Operating Procedures (SOPs) for all manufacturing processes and quality control operations.
∎ Ensure adherence to established QMS policies across all production and quality control units.
∎ 2. Auditing & Compliance:
∎ Plan, conduct, and oversee internal and external audits to evaluate compliance with regulatory standards and company policies.
∎ Prepare for and facilitate regulatory inspections from government agencies and certification bodies, ensuring successful outcomes.
∎ Implement Corrective and Preventive Action (CAPA) plans based on audit findings to strengthen quality systems.
∎ 3. Product Quality Control:
∎ Ensure quality standards are maintained throughout the manufacturing process, from raw material inspection to finished product release.
∎ Review and approve batch records, validation reports, and other documentation to ensure accuracy and compliance.
∎ Perform Root Cause Analysis (RCA) for deviations and implement corrective actions to prevent recurrence.
∎ 4. Risk Management & Validation:
∎ Identify potential quality risks and develop mitigation strategies to maintain product integrity.
∎ Oversee validation processes for equipment, manufacturing processes, cleaning, and packaging to ensure consistent quality.
∎ 5. Documentation & Reporting:
∎ • Maintain accurate and up-to-date quality assurance records, including audits, inspections, validations, and SOPs.
∎ Prepare detailed quality reports for senior management and regulatory authorities.
∎ Ensure timely submission of documentation required for regulatory approvals and certifications.
∎ 6. Training & Leadership:
∎ Lead, mentor, and guide the QA team, promoting a culture of continuous improvement and excellence.
∎ Conduct regular training sessions for staff on GMP, GLP, SOPs, and regulatory standards.
∎ Encourage teamwork and collaboration across departments to ensure adherence to quality standards.
∎ 7. Collaboration & Continuous Improvement:
∎ Work closely with Production, PD, and Regulatory Affairs teams to enhance quality processes.
∎ Monitor industry trends, technological advancements, and regulatory updates to maintain the highest standards.
∎ Develop and implement strategies for continuous improvement in quality systems and processes.
∎ 8. Customer Complaint Handling:
∎ Investigate and resolve quality-related complaints from customers with thorough root cause analysis.
∎ Implement measures to prevent recurrence and enhance overall product quality.

Workplace:
∎ Work at office

Employment Status: Full Time

Job Location: Rangpur (Rangpur Sadar)

Read Before Apply:

Alkad Laboratories is a reputed pharmaceutical company based in Rangpur, committed to producing high-quality pharmaceutical products that meet national and international standards. We are looking for a skilled and experienced Quality Assurance Manager to join our team and ensure our products meet the highest standards of quality, safety, and regulatory compliance.

Interested candidates are requested to send their updated CVs to [email protected] Please mention "QA Manager Application - Alkad Laboratories" in the email subject line.