Sr. Executive/AM

• JD
• IPQA: In-Process Quality Assurance
• APQR: Annual Product Quality Review
• QMS: Quality Management System
• PROCESS VALIDATION: The process of verifying that a manufacturing process produces a product that meets its predetermined specifications and quality attributes.

With 8-12 years of experience, here's a possible job description:

Job Title: Senior Quality Assurance Specialist/Process Validation Specialist

Job Summary:

We are seeking an experienced Senior Quality Assurance Specialist/Process Validation Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements, implementing and maintaining a robust Quality Management System (QMS), and leading process validation activities to ensure the quality of our products.

Key Responsibilities:

1. Develop, implement, and maintain a comprehensive QMS that meets regulatory requirements and industry standards.
2. Conduct In-Process Quality Assurance (IPQA) activities to ensure that products are manufactured in accordance with established procedures and specifications.
3. Lead Annual Product Quality Review (APQR) activities to evaluate product quality and identify areas for improvement.
4. Design, execute, and report process validation studies to ensure that manufacturing processes produce products that meet predetermined specifications and quality attributes.
5. Collaborate with cross-functional teams to identify and mitigate quality risks, and implement corrective and preventive actions (CAPAs) as needed.
6. Develop and deliver training programs to ensure that personnel are aware of and comply with QMS requirements and procedures.
7. Participate in internal and external audits to ensure compliance with regulatory requirements and industry standards.

Requirements:

• 8-12 years of experience in quality assurance, process validation, or a related field
• Qualification - Msc, B pharm, Mpharm
• Strong knowledge of QMS principles, regulatory requirements (e.g., who, EU GMP).
• Experience with process validation, IPQA, and APQR activities
• Excellent communication, leadership, and problem-solving skills
• Ability to work in a fast-paced environment and prioritize multiple tasks and projects
• OSD Exposure must.