Officer / Senior Officer – Quality Control

We are currently seeking a qualified professional for an Officer / Senior Officer – Quality Control position at our facility in Dahej SEZ 2. In this role, you will be responsible for the routine analysis of raw materials and finished products for Sterile Injectables. Additionally, you must ensure that all processes adhere strictly to cGMP and regulatory requirements. Consequently, this position is vital for maintaining the highest standards of product quality and safety.

The Officer / Senior Officer – Quality Control will operate and maintain advanced analytical instruments such as HPLC and GC. Furthermore, you will handle deviations and participate in root cause analysis with CAPA implementation. Therefore, we are looking for an analytical professional with a strong understanding of data integrity and laboratory investigations.

Key Responsibilities

• Perform routine analysis of raw materials, in-process samples, and finished products.
• Operate and maintain analytical instruments including HPLC, GC, UV, IR, TOC, and KF.
• Ensure all analysis is carried out as per cGMP, SOPs, and pharmacopeial methods.
• Review and prepare critical analytical documents, COAs, and detailed laboratory reports.
• Handle OOS and OOT results while participating in root cause analysis and CAPA implementation.
• Coordinate with QA, Production, and Regulatory Affairs to ensure the timely release of products.
• Support method validation, equipment qualification, and comprehensive laboratory investigations.
• Prepare for regulatory inspections (USFDA, MHRA, EU) and maintain full compliance with guidelines.
• Train and guide junior analysts in best QC practices, data integrity, and workplace safety.

Requirements and Qualifications

Education and Experience

• M.Sc in Chemistry, B.Pharm, or M.Pharm degree.
• 3–6 years of QC experience specifically in Sterile Injectables or Parenterals.
• Hands-on experience in operating HPLC, GC, and other modern QC instrumentation.

Technical Skills and Abilities

• Strong understanding of Good Manufacturing Practices (GMP) and data integrity standards.
• Excellent analytical, documentation, and problem-solving skills within a regulated environment.
• Ability to thrive in a fast-paced setting while adapting to dynamic regulatory changes.
• Proven capability in coordinating with multi-disciplinary teams for compliance and product release.

What We Look For

• A meticulous individual with a keen analytical mindset and strong attention to detail.
• A professional dedicated to maintaining high standards of accuracy and regulatory compliance.
• A collaborative team player capable of delivering high-quality results under tight deadlines.

If you are a QC professional ready to lead high-speed analytical operations in a Sterile Injectable environment, we encourage you to apply for this Officer / Senior Officer – Quality Control position today!