QA

Must know process validation cleaning validation verification and hold time studies. Candidate should also have exposure to EU, MHRA, and USFDA regulatory audits.

Analysis / Operation on HPLC/GC/FP/IP/RM/PM/Lab Monitoring. Environment Monitoring. Media Preparation and Autoclaving, MLT, BET, Sterility Testing. IPQA, QMS-Change Control. Investigation (Deviation / OOS / OOT). Market complaint. Cleaning Validation, AQA, Qualification of Equipment, Audit Compliance and Documentation.

2-8 years of experience in BMR, QMS, PQR, Qualification, AQA, ERP, Control Sample, Process Validation.

Skilled in process validation document preparation and review, with strong knowledge of QMS, qualification documents, regulatory audits, and vendor qualification and audits in a regulated environment.

Candidate must not have done apprenticeship earlier. Pass out batch of year 2022, 2023 & 2024 are eligible.

Hetero Drugs is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.

Established in 2012, Honour Lab Limited is engaged in the manufacturing of Active Pharmaceutical Ingredients and Intermediates.

HPLC, GC, dissolution apparatus, UV visible spectrometer, weight analysis, stability, GLP. Granulation, Compression, Coating, Wurster coating, Capsule filling

Water and Bioburden Testing and Microbiological limit testing, Sterility Testing and BET Testing, IQ,OQ and PQ of equipment, Trend Analysis preparation, Biological reactivity test, EM Observation - Moda exposure