Posted:13 hours ago|
Platform:
On-site
Full Time
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
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.
MEDICAMEN BIOTECH LIMITED
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