of all GMP documents like SMF, VMP, Quality Manual, SOP, Protocol, Drawing,
BMR, APR & Stability Protocols.
2.Review of master
documents such as SOPs, specifications, test procedures,
qualification/validation protocols, reports and batch documents etc.
responsible for conducting Quality Risk Management exercises and function as
site QRM coordinator.
review and upgrade systems, procedures as per current updates and cGMP
5.To ensure good documentation
by all the concerned and all the documents are as per current GMP requirements
and in-house SOPs.
non-conformances, deviation, change control and CAPA. Act as site coordinator
for deviation, change control, CAPA and non- conformance.
7.Involve and review
Investigations related to Product complaints & ensure that appropriate
measures are taken to prevent recurrence.
compliance reports and implementation of CAPA for all internal & external
9.To perform Gap analysis
at regular interval to identify any gaps in quality system with respect to
change in SOP, update in pharmacopeia, change in any regulatory guidelines
etc., and to inform head of department and their implementation.
10.To review and
ensure compliance to observation during self-inspection /external audit.
coordinating internal audits at site, including tracking of audit reports, CAPA
and its timely closure.
12.Review of quality
related issues & documents as per requirements of quality assurance head.
trending of key quality system elements such as change control, deviation.
CAPA, internal audits etc. and assist in management review meeting.
responsible for coordinating and participating in failure investigations/OOS/OOT
from quality assurance.
responsibilities assigned by department head.
1.About 5 years of
experience in regulated environment within biopharmaceutical/sterile
2.Good knowledge of
quality assurance methodologies and processes
3.Good knowledge of
MS Office and databases
skills, fluent in English, both written and spoken
5.Good attention to
detail and a result driven approach
Masters in Pharmacy / Biotechnology related discipline.
stringent regulatory audits such as EMEA, US FDA, GCC/SFDA