Title:  Senior Executive - Quality Control

Job Purpose

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.

Documentation & Compliance

• 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.

Instrument & Method Handling

• 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.

Quality Systems Support

• 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.

Educational Qualification

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

Experience

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

Technical Skills & Knowledge

• 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

Behavioral & Soft Skills

• 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

Preferred / Added Advantage

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