Titan Laboratories Pvt. Ltd.
Website:
titan-lab.com
Job details:
Job Title: QC Officer - Analyst (HPLC Operator – Finished Formulations)
Job Overview:We are seeking a knowledgeable and audit-ready QC Analyst with hands-on experience in handling HPLC systems (21 CFR compliant) and other analytical instruments such as GC, UV, IR, and Dissolution apparatus. The ideal candidate will be responsible for maintaining reserve samples, reviewing quality data, and ensuring compliance with international regulatory standards including EU GMP, USFDA, MHRA, TGA, and WHO-GMP.
Strong technical expertise, documentation skills, and the ability to confidently handle regulatory audits are essential for this role.
Job Overview: 3 to 5 years
Key Responsibilities:- Operate and manage HPLC systems compliant with 21 CFR requirements
- Handle analytical instruments including: HPLC, Gas Chromatography (GC), UV Spectrophotometer, Infrared (IR) Spectroscopy, Dissolution apparatus
- Maintain and review reserve samples and ensure their quality compliance
- Follow and implement Standard Operating Procedures (SOPs) for analytical activities
- Perform calibration and routine maintenance of laboratory instruments
- Ensure proper documentation practices in line with regulatory requirements
- Maintain compliance with international standards: EU GMP, WHO-GMP, cGMP, MHRA, USFDA, TGA
- Participate in and face regulatory audits (e.g., EU GMP, MHRA, USFDA, TGA)
- Ensure accuracy, integrity, and traceability of all analytical data
- Communicate effectively within the team and across departments
Qualifications:- M.Sc / B.Sc / B.Pharm / M.Pharm in a relevant field
Click on Apply to know more.