MEDICAMEN BIOTECH LIMITED

Hiring Alert! We are hiring Assistanat Manager-QA for our Oncology Plant facility (USFDA) at Haridwar Location. Good Communication Skill is mandatory. Education-B.Pharma, M.Pharma Experince:-10+Years Package-7.2 to 10.0 LPA CTC Email Id:-hrhrd@medicamen.com (M) +91 – 9997797518 1. QA QMS 1) Responsible for review & compliance of cross functional department SOPs. 2) Preparation & review of standard operating procedures related to QA. 3) Responsible for handling of QMS document like change control, deviation, incident, CAPA, market complaints, product recall etc. 4) Preparation & review of risk assessment and mitigation of residual risk by identifying appropriate CAPA. 5) Responsible for imparting training on QA SOPs, capturing GxP, GMP/cGMP related updates updated in any other guidelines (ICH, USP, EU-GMP, ISO etc.). 6) Responsible for receiving training as per yearly training calendar & otherwise also. 7) Responsible for handling the technology transfer of products as per approved procedure. 8) Responsible for execution of internal audits/self inspection within the plant as per the schedule and ensure timely compliance of the observations. 9) Responsible for review of SMF & Quality Manual and update the same based on cGMP requirement.