Quality Assurance Executive - Pharma - Formulation - Rudrapur

Quality Assurance - QMS (Quality Management System), with a specialization in injectable products.

Core Responsibilities:

Quality Management & Documentation:

• Oversee and manage Change Control, Deviation, and Out of Specification processes.
• Handle Market Complaints and lead Corrective and Preventive Actions (CAPA).
• Conduct Annual Product Quality Reviews and ensure timely submission of Audit Compliance Reports.
• Ensure comprehensive knowledge and experience in ERP systems.
• Hands-on experience in quality management of injectable products is essential.

Document Control & Preparation:

• Prepare Standard Operating Procedures (SOPs), Site Master Plans, and Validation Master Plans.
• Manage documentation for regulatory submissions, including declarations, customer free samples, vendor samples, and customer queries.
• Develop policies and system procedures to ensure compliance with industry standards.
• Prepare and manage the Training Calendar.

Desired Candidate Profile:

• Educational Qualification: B. Pharm / M. Pharm / M.Sc. in Chemistry or a related field.
• Experience: 5 to 7 years in the formulation industry, with a focus on quality assurance.
• Skills:
• Proficient in Quality Management tools.
• Strong regulatory exposure.
• Proficiency in preparing presentations and reports.
• Fluent in English and Hindi (written and spoken).

Additional Details:

• Interview Process:
1. Initial round: Telephonic.
2. Final round: Face-to-face interview.

Availability: Preference will be given to candidates who can join within 15 days or immediately.