Head of Quality

Experience:

Location:

About Macsen Drugs:

Job Overview:

Responsibilities:

1. Quality Assurance (QA)

• Develop and implement a comprehensive Quality Management System (QMS) compliant with cGMP and ICH guidelines.

• Review and approve quality documents such as SOPs, batch records, deviations, and CAPA reports.

• Ensure the site is prepared for regulatory audits and inspections from USFDA, EMA, WHO, and other agencies.

• Conduct internal audits and self-inspections to maintain quality standards. 

2. Quality Control (QC)

• Oversee laboratory operations, ensuring raw materials, intermediates, and finished products meet established quality specifications.

• Manage analytical method validations and stability studies. • Monitor calibration and maintenance of laboratory instruments.

3. Regulatory Affairs

• Prepare and submit regulatory documents, including DMFs, for US and international markets.

• Address regulatory queries and implement corrective actions for observations from audits or inspections. • Stay updated on global regulatory trends and ensure compliance with evolving requirements. 

4. Production Oversight

• Collaborate with production teams to ensure manufacturing processes align with quality standards.

• Oversee cleaning and process validation for a multi-product facility to prevent cross-contamination.

• Troubleshoot production and analytical challenges in coordination with R&D.

5. Data Integrity and Security

• Ensure compliance with 21 CFR Part 11 for electronic records, signatures, and data integrity.

• Establish protocols for data security and governance across all quality operations.

6. Cross-Functional Coordination

• Work with R&D and Analytical Development Labs for seamless technology transfer and method development.

• Collaborate with Stores and Maintenance teams to ensure proper inventory management and equipment validation.

• Coordinate training programs for team members to maintain high-quality standards.

7. Leadership

• Lead and mentor teams across QA, QC, Regulatory, Production, and Maintenance departments.

• Foster a culture of quality, accountability, and continuous improvement.

1. Educational Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field.

• Additional certifications in Quality Management Systems (e.g., ISO 9001, Six Sigma) are preferred.

2. Experience Requirements

• Minimum 15 years of experience in API manufacturing, with at least 5 years in a leadership role managing QA, QC, and Regulatory Affairs.

• Proven experience in handling audits and inspections by regulatory agencies such as USFDA, EMA, WHO, or PICS.

• Hands-on experience in managing multi-product facilities with cleaning and process validation expertise.

How to Apply: Send your updated resume to hrd@macsenlab.com