Assistant Manager, Quality Control

RXinsider LTD.; Ahmedabad District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

RXinsider LTD. in Gujarat seeks an experienced Quality Control Lead to oversee QC operations in a pharmaceutical manufacturing environment, ensuring GMP/GLP compliance and patient safety.

The role requires leading a team of QC professionals, coordinating with manufacturing, regulatory affairs, and QA, and driving preventive measures and continuous improvements while maintaining rigorous documentation and timely resolution of deviations.

Qualifications

• Bachelor\'s degree in science (B. Sc.) required.
• Master\'s degree preferred.
• 8–10 years of experience in quality control in pharmaceutical manufacturing.

Responsibilities

• Lead and manage quality control operations to ensure compliance with GMP/GLP and regulatory requirements.
• Oversee in-process and final product quality analyses and inspections against predefined quality standards.
• Identify ongoing quality issues and implement preventive measures and continuous improvement initiatives across QC functions.
• Develop and coach QC team; provide technical guidance and performance oversight.
• Audit and monitor manufacturing processes and QC outputs against internal and regulatory standards.
• Oversee testing of random finished goods samples to verify quality compliance.
• Report deviations and defects to senior leadership and ensure timely resolution of issues.
• Collaborate with manufacturing, regulatory affairs, and QA to address quality challenges.
• Maintain accurate documentation of QC activities in GMP/GLP compliant manner.

Skills

Quality control leadership

Regulatory compliance

Quality analysis

Cross-functional collaboration

Documentation

Education

Bachelors Degree (BA/BS) B. Sc. - Required

Master Degree (MS/MA) M. Sc. - Preferred

Job description

Description

JOB DESCRIPTION

This role is responsible for leading and managing quality control operations within a pharmaceutical manufacturing environment, ensuring compliance with established standards and regulatory requirements. The incumbent oversees in-process and final product quality analyses and inspections, interpreting and evaluating results against predetermined specifications to ensure product integrity and patient safety. The position identifies ongoing quality issues, implements preventive measures, and drives continuous improvement initiatives across quality control functions. It manages a team of quality control professionals, providing technical guidance, coaching, and performance oversight to build a high-performing quality control function. The role audits and monitors manufacturing processes and quality control outputs against both internal and regulatory standards to uphold compliance and drive operational excellence. It oversees the testing of random samples of finished goods and ensures conformance with quality specifications and regulatory expectations. The position reports manufacturing process deviations and defects to senior quality leadership and ensures timely resolution of quality issues. It supports the organization's commitment to delivering safe, effective, and compliant pharmaceutical products by building and sustaining a robust quality control capability.

Essential Functions

• Lead and manage quality control operations to ensure compliance with established specifications and regulatory requirements.
• Oversee in-process and final product quality analyses and inspections, interpreting results against predetermined quality standards.
• Identify ongoing quality issues and implement preventive measures and continuous improvement initiatives across quality control functions.
• Manage and develop a team of quality control professionals, providing technical guidance, coaching, and performance oversight.
• Audit and monitor manufacturing processes and quality control outputs against defined internal and regulatory quality standards.
• Oversee the testing of random samples of finished goods to verify compliance with quality specifications.
• Report manufacturing process deviations and defects to senior quality leadership and ensure timely resolution of quality issues.
• Collaborate with cross-functional teams including manufacturing, regulatory affairs, and quality assurance to address quality challenges.
• Maintain accurate and complete documentation of all quality control activities in compliance with GMP and GLP requirements.

QUALIFICATIONS

Education

• Bachelors Degree (BA/BS) B. Sc. - Required
• Master Degree (MS/MA) M. Sc. - Preferred

Experience

• 8 years or more in 8 - 10 Years