QA Manager

A QA (Quality Assurance) Manager in the pharmaceutical industry plays a critical role in ensuring that products meet regulatory standards, are safe for consumers, and are consistently produced to the highest quality. Below are the key responsibilities of a QA Manager in the pharmaceutical sector:

1. Regulatory Compliance

• Ensure compliance with local and international regulatory requirements (e.g., FDA, EMA, WHO, MHRA).
• Stay updated on changes in regulations and implement necessary adjustments to maintain compliance.
• Prepare and manage documentation for regulatory inspections and audits.

2. Quality Management System (QMS)

• Develop, implement, and maintain the Quality Management System (QMS) to ensure adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
• Oversee the creation and revision of Standard Operating Procedures (SOPs), policies, and guidelines.
• Conduct regular internal audits to ensure QMS effectiveness.

3. Product Quality Oversight

• Monitor and ensure the quality of raw materials, intermediates, and finished products.
• Review batch records, test results, and other documentation to approve or reject products.
• Investigate and resolve quality issues, deviations, and non-conformances.

4. Risk Management

• Identify, assess, and mitigate risks related to product quality and compliance.
• Implement risk-based approaches to quality assurance and control.

5. Audits and Inspections

• Lead and manage internal and external audits, including regulatory inspections.
• Coordinate responses to audit findings and ensure timely implementation of corrective and preventive actions (CAPAs).

6. Training and Development

• Train and mentor staff on quality standards, SOPs, and regulatory requirements.
• Promote a culture of quality and compliance throughout the organization.

7. Supplier and Vendor Management

• Qualify and audit suppliers, contractors, and vendors to ensure they meet quality standards.
• Monitor supplier performance and address any quality-related issues.

8. Document Control

• Oversee the documentation system to ensure accuracy, completeness, and traceability of all quality-related records.
• Ensure proper archiving and retrieval of documents.

9. Continuous Improvement

• Identify opportunities for process improvement and implement best practices.
• Use quality metrics and data analysis to drive decision-making and improve quality systems.

10. Cross-Functional Collaboration

• Work closely with R&D, manufacturing, regulatory affairs, and other departments to ensure quality is integrated into all processes.
• Participate in product development and launch activities to ensure quality considerations are addressed.

11. Customer Complaint Handling

• Oversee the investigation and resolution of customer complaints related to product quality.
• Ensure timely communication with customers and regulatory authorities, if required.

12. Environmental, Health, and Safety (EHS)

• Ensure compliance with EHS regulations and promote a safe working environment.

13. Reporting and Communication

• Prepare and present quality reports to senior management.
• Communicate quality-related issues and trends to stakeholders.

14. Crisis Management

• Lead quality-related crisis management efforts, including product recalls or market withdrawals, if necessary.

15. Budget Management

• Manage the QA department budget, including resources, equipment, and training.

Key Skills and Qualifications:

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, or a related field.
• Extensive knowledge of GMP, GLP, GCP, and regulatory requirements.
• Strong leadership, communication, and problem-solving skills.
• Experience in managing audits, inspections, and CAPA processes.
• Proficiency in quality management software and tools.

Job Type: Full-time

Pay: $80,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Paid time off

Schedule:

• 8 hour shift

Ability to Commute:

• Hauppauge, NY 11788 (Required)

Ability to Relocate:

• Hauppauge, NY 11788: Relocate before starting work (Required)

Work Location: In person

Salary : $80,000 - $120,000