Position : Research Associate/ Senior Research Associate- Clinical QC
Location : Chhatrapati Sambhajinagar (Aurangabad), Maharashtra
Qualification: M. Pharm
Experience: 2-4 years experience in Clinical QC/QA
Requirements :
Knowledge of regulatory - USFDA, EMEA, GCP guidelines. NDCT Rules and ICMR Guidelines
Experience of TMF, Clinical Updates, CSR and Compliance Management
In depth understanding of BA/ BE, Clamp Studies
Knowledge of SOPs, AE/ SAE, Informed Consent, Protocols, CRF etc.
Well versed with IP accountability and Pharmacy Management
Experience of SOP preparation, Document Review, SOP Trainings and records maintenance. EC & regulatory submissions, approvals and Audit process.
Wockhardt is a multinational pharmaceutical and biotechnology company that provides affordable, high-quality medicines to help make the world a healthier place. It is India's leading research-based global healthcare organization, with interests in pharmaceuticals, biotechnology, and a network of advanced Super Speciality Hospitals.
Wockhardt is a real Indian Multi-National Company, employing 8600 Wockhardt Associates from 21 different nationalities worldwide. It has three research centers and twelve manufacturing units, and its products include pharmaceutical and bio-pharmaceutical formulations, active pharmaceutical ingredients (APIs), and vaccines.