Job Description:

Position: Quality Assurance (QA) Specialist
Industry: Pharmaceutical API Manufacturing
Experience Required: 2 to 5 Years
Location: Chiplun

Overview:

Our client, a leading API manufacturing company operating in regulated markets, is seeking a skilled Quality Assurance (QA) Specialist. The ideal candidate will have 2 to 5 years of hands-on experience in QA within the pharmaceutical industry, specifically in API manufacturing. This role is essential for ensuring that quality systems and procedures are rigorously followed, contributing to the production of high-quality pharmaceutical products.

Key Responsibilities:

• Quality Systems Management: Implement and manage quality systems such as Product Quality Review (PQR), Change Controls, Deviations, and Out-of-Specification (OOS) investigations to maintain compliance with regulatory standards.
• Batch Release & Document Review: Oversee batch release processes, ensuring all production and associated documents meet the required quality standards before product release.
• Cleaning Validation: Conduct and document cleaning validation activities to ensure cleanliness and prevent cross-contamination in the manufacturing process.
• Regulatory Compliance: Ensure all processes and products comply with regulatory requirements for API manufacturing in regulated markets.

Key Requirements:

• Experience: Minimum of 2 to 5 years in a reputed API manufacturing company that operates in regulated markets.
• Quality Systems: Strong understanding and experience with PQR, Change Controls, Deviations, OOS, and other quality systems.
• Batch Release Procedures: In-depth knowledge of batch release and review procedures, ensuring that all documents and processes meet quality standards.
• Cleaning Validation: Experience with cleaning validation activities, ensuring that all equipment and processes are compliant with industry standards.
• Regulated Markets: Familiarity with the stringent requirements and standards necessary for API manufacturing in regulated markets.

Why Join Us?

• Work with a leading pharmaceutical company renowned for its commitment to quality and innovation in API manufacturing.
• Be part of a dynamic team focused on ensuring the highest standards of product quality and regulatory compliance.
• Enhance your skills and experience in a challenging and rewarding QA role.

Apply Now:
If you meet the above requirements and are passionate about maintaining high-quality standards in pharmaceutical API manufacturing, we encourage you to apply. Join us in our mission to deliver safe and effective pharmaceutical products to regulated markets.