Quality Assurance Manager

Urgently Required

Quality Assurance Manager

Experience :  1 to 5 years

No of vacancies :  1

Job Description: The Quality Assurance Manager is responsible for implementing and managing quality systems to ensure that pharmaceutical products meet regulatory standards and organizational quality objectives. This role involves overseeing day-to-day quality assurance activities, ensuring compliance with GMP, and driving continuous improvement in processes and product quality.

Key Responsibilities: Quality Systems Implementation: Ensure the effective implementation of quality management systems in compliance with GMP, WHO-GMP, and regulatory guidelines.
Regulatory Compliance: Monitor and ensure that all manufacturing processes comply with domestic (CDSCO, Schedule M) and international (USFDA, EMA) regulations.
Documentation Oversight: Review and approve quality-related documents, including batch records, SOPs, deviation reports, and CAPA plans.
Internal Audits: Plan and conduct internal quality audits to identify gaps and ensure continuous compliance.
Supplier Quality Assurance: Evaluate and audit suppliers to ensure the quality of raw materials and components.
Process Validation: Collaborate with production and quality control teams to validate processes and equipment.
Team Supervision: Lead and guide the quality assurance team, fostering a culture of accountability and quality excellence.
Training: Conduct training sessions to ensure staff awareness and adherence to quality standards.
Issue Resolution: Investigate quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA).
Continuous Improvement: Drive quality improvement initiatives across the organization.

Education Qualifications: Minimum Requirements: Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Microbiology, or a related field.
Preferred: Master’s degree in Quality Assurance, Regulatory Affairs, or a related field.
Certifications: GMP, ISO 9001 Lead Auditor, or Six Sigma certification is advantageous.
Experience: Proven experience in quality assurance roles, preferably in the pharmaceutical industry.

Key Attributes: Detail-Oriented: Commitment to accuracy in documentation and process oversight.
Problem-Solving: Strong analytical skills to identify and address quality issues.
Regulatory Knowledge: Familiarity with GMP and other relevant quality standards.
Leadership: Ability to lead and motivate a team.
Communication: Proficient in reporting and collaborating with cross-functional teams.

About the Role: The Quality Assurance Manager ensures that all pharmaceutical products and processes meet the highest quality standards and comply with regulatory requirements. This role involves managing quality systems, supervising audits, and coordinating with multiple departments to maintain product quality and safety. The manager plays a critical role in maintaining customer trust and ensuring regulatory compliance.