Senior Executive - Quality Control

Job Purpose

To perform routine and non‑routine analytical testing using HPLC and related instruments for raw materials, in‑process samples, finished products, and stability samples, ensuring compliance with USFDA, cGMP, and data integrity requirements.

Key Responsibilities Analytical Testing

• Perform analysis using HPLC for:
• Raw materials
• In‑process samples
• Finished products
• Stability samples
• Execute tests as per:
• Approved specifications
• STPs / SOPs
• Pharmacopoeial requirements (USP, IP, EP, BP)
• Operate and maintain HPLC systems, including troubleshooting basic instrument issues.
• Prepare mobile phases, standards, reagents, and solutions as per approved procedures.

• Ensure accurate and contemporaneous documentation in:
• Analytical worksheets
• Logbooks
• Electronic systems (as applicable)
• Review and verify analytical data for accuracy and completeness.
• Ensure compliance with cGMP, USFDA regulations, and ALCOA+ data integrity principles.
• Adhere to good documentation practices (GDP) at all times.

• Support method verification, method transfer, and method validation activities.
• Perform system suitability tests and ensure compliance before analysis.
• Participate in calibration and routine maintenance of HPLC instruments.
• Handle out‑of‑trend (OOT) observations and assist in investigations when required.
  
  

• Participate in OOS, OOT, and deviation investigations related to analytical testing.
• Support stability studies and sample management.
• Assist during internal audits, regulatory inspections, and customer audits.
• Follow EHS and laboratory safety guidelines strictly.
  
  

• Bachelor’s or Master’s degree in:
• Pharmacy (B.Pharm / M.Pharm)
• Chemistry / Analytical Chemistry (B.Sc / M.Sc)
• or related scientific discipline

• 6–8 years of hands‑on experience as a QC Analyst
• Mandatory experience in HPLC analysis within a USFDA‑approved OSD manufacturing plant
  
  

• Strong working knowledge of:
• HPLC systems and software
• OSD dosage forms (tablets, capsules)
• cGMP and USFDA requirements
• Familiarity with:
• Stability testing
• Pharmacopoeial testing
• QMS elements (OOS, deviation, CAPA – support level)
• Basic understanding of data integrity expectations

• Attention to detail and accuracy
• Good analytical and problem‑solving skills
• Ability to work independently and in a team
• Clear communication and documentation skills
• Compliance‑focused mindset
  
  

• Exposure to regulatory inspections (USFDA, MHRA, WHO)
• Experience with LIMS or electronic data systems
• Knowledge of GC / UV / Dissolution (additional advantage)