QA Manager cosmetic & pharma manufacturer

Quality (QA) Manager for Delon Laboratories. We are a large personal care cosmetics and topical OTC manufacturer supplying customers and brands across the globe. Manufacturing facility plays a crucial role in ensuring that the production processes, products, and facilities comply with industry standards, regulatory guidelines, and internal quality protocols. Their work helps guarantee that products are safe, effective, and of high quality before they reach customers and consumers.

Our business is very fast paced with many developments, new inquiries and projects and requests happening all the time.

Key Responsibilities of a QA Manager :

1. Quality Systems Management:

• Establish, monitor, and maintain Quality Management Systems to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements (e.g., HC, FDA, EU etc).
• Develop, review, and update Standard Operating Procedures (SOPs), batch records, and documentation relevant to filling and production operations.
• Implement corrective and preventive actions (CAPA) for any quality issues identified during audits or inspections.

2. Process Oversight and Validation:

• Oversee the production processes to ensure they meet quality standards and regulatory guidelines.
• Manage process validation, cleaning validation, and equipment validation to confirm consistent product quality.
• Monitor critical process parameters, including fill volume, sealing, sterilization, and container closure integrity.

3. Batch Record Review and Release:

• Review batch manufacturing records and documentation to ensure accuracy and completeness.
• Authorize the release of finished product batches after thorough review of quality test results, batch records, and deviation reports.
• Ensure that any deviations from the process are documented, investigated, and resolved before product release.

4. Quality Control and Testing:

• Collaborate with the Quality Control (QC) team to ensure that raw materials, in-process materials, and finished products are tested and meet specified quality standards.
• Implement stability testing programs to confirm product shelf life and potency over time.
• Address out-of-specification (OOS) results and ensure proper investigation and resolution.

5. Audits and Inspections:

• Prepare the facility and team for internal audits and external inspections by regulatory authorities.
• Conduct internal audits to identify compliance gaps and drive continuous improvement initiatives.
• Coordinate responses to audit findings and ensure timely implementation of corrective actions.

6. Training and Compliance:

• Develop and deliver training programs for employees on quality assurance, GMP, and safety procedures.
• Ensure that all personnel involved in operations are adequately trained and comply with SOPs.
• Promote a culture of quality and compliance within the facility.

7. Risk Management:

• Conduct risk assessments related to the production processes, equipment, and facility environment.
• Implement strategies to mitigate risks, such as contamination, cross-contamination, or equipment failure.

8. Change Control Management:

• Manage change control processes to ensure that any changes to equipment, processes, or formulations do not impact product quality.
• Review and approve changes in formulation, packaging, or equipment to ensure they meet quality standards.

9. Continuous Improvement:

• Analyze quality metrics and performance data to identify areas for process improvement.
• Implement Lean Manufacturing, Six Sigma, or other quality improvement methodologies to enhance efficiency and reduce waste.

10. Managing Departments

• Ability to manage their team and departments.
• Delegate and monitor work load and ongoing tasks in order to make sure work is distributed correctly, followed up in a timely manner, and dealt with accordingly.
• Ability to conduct performance reviews, to hire/terminate personnel to make sure the team is running smoothly, efficiently and to its full potential.

Skills and Qualifications

• Educational Background: Bachelor's or master's degree in sciences, chemistry, biology, or science related field.
• Experience: Extensive experience in a manufacturing environment + managed departments successfully.
• Knowledge: Strong understanding of GMP, FDA EU regulations, quality control, and validation processes.
• Skills: Attention to detail, analytical thinking, problem-solving, project management, leadership, and communication skills.

Impact on the Organization:

• A QA Manager ensures that products are manufactured in compliance with strict regulatory standards., maintaining the company's reputation, and avoiding costly rejects or recalls or regulatory penalties.