Executive Third Party Manufacturing QA at Galpha Laboratories Limited

Job Description: Executive Third Party Manufacturing QA

Position: Executive Third Party Manufacturing QA
Location: Baddi
Department: Quality Assurance
Reports to: Head-CQA

Job Summary:
The Executive Third Party Manufacturing QA will be responsible for overseeing the quality assurance processes of products manufactured on a third-party and loan license basis. This role ensures that all products meet the company's quality standards and comply with regulatory requirements. The candidate will work closely with third-party manufacturing units to maintain and enhance product quality.

Key Responsibilities:

1. Quality Assurance Management:
   • Monitor and evaluate the quality assurance processes at third-party manufacturing sites.
   • Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
   • Conduct regular visits and inspections of third-party manufacturing facilities.
   • Review and approve quality-related documents, including batch records, analytical documents etc.
2. Collaboration and Communication:
   • Liaise with third-party manufacturers to ensure adherence to quality standards.
   • Provide technical support and guidance to third-party manufacturing units.
3. Documentation and Reporting:
   • Maintain comprehensive and accurate records of quality assurance activities.
   • Prepare and present quality reports to CQA-Head.
4. Continuous Improvement:
   • Identify areas for improvement in the manufacturing process and quality systems.
   • Implement corrective and preventive actions (CAPA) to address quality issues.
   • Promote a culture of continuous improvement and quality excellence.
5. Training and Development:
   • Conduct training sessions for third-party manufacturers on quality standards and regulatory requirements.
   • Stay updated with the latest industry trends and regulatory changes to ensure compliance.

Qualifications:

• Bachelor's/Master's degree in Pharmacy (B.Pharm), Chemistry, or a related field.
• Minimum [06] years of experience in pharmaceutical quality assurance, preferably with experience in third-party manufacturing.
• In-depth knowledge of GMP, regulatory guidelines, and quality assurance processes.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and manage multiple tasks simultaneously.
• Proficiency in MS Office and quality management software.

Preferred Skills:

• Experience with international regulatory requirements (e.g., FDA, EMA).
• Knowledge of quality management systems (QMS) and tools.
• Certification in quality assurance or related fields (e.g., Six Sigma, ISO).

What We Offer:

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• A dynamic and collaborative work environment.