Manager QA

JOB DESCRIPTION OF PROPOSED MANAGER QA Opthalmology

Job Responsibilities
Having 1520 years of experience in pharmaceutical industry and acting as site
QA Head role since last 5 years (Oral solid dosage form/Injectable dosage form).
To ensure overall compliance of cGMP/GLP

Practices at plant:
Ensure that all the inprocess QA activities carried out as per the requirement
and resolve day to day operational related issues.
Harmonization of Quality Management system.
Establishing effective Quality systems standards & cGMP procedure at site.
Authorize all master documents viz. SOP Master Production/Packing Control
Records
Validation/Qualification Protocols and Reports Standard Testing Procedure
Annual Product review.
Review Reports Analytical Method Transfer Reports etc. and relevant formats.
Effective adherence to the training system to ensure cGMP activities are
performed by trained and qualified persons.
Training SelfInspection etc. and monitoring of the adherence of the schedule.
Ensure successful regulatory inspection and timely closure of regulatory
commitments.
Ensure good documentation practices followed to paper and electronic records
Ensure adherence of Data Integrity Policy.
Hands on experience on review and approval of QMS elements viz. Change
Controls
Ensure adherence of Data Integrity Policy.

Hands on experience on review and approval of QMS elements viz. Change
Controls Deviation Investigation CAPA. Market complaint and Product Recall
Ensure effective corrective / preventive actions are implemented.
Effectively and timely closure of market complaints OOS OOT and other QMS
elements.
Ensure to provide technical support and timely submission of documents to
regulatory. To ensure electronic software implementation
Responsible for Batch Release
Review and approval of technical agreements.
Hands on exposure on 21 CFR part 11 / EU
cGMP requirements for process equipment qualification / Lab instrument.
Ensure compliance of process validation cleaning validation and equipment /
utility qualification including media fill and smoke study. Ensure that the
processes and system remains in a state of validation and compliance. QA
oversight in QC activities
Hands on experience on various regulatory audits i.e. USFDA MHRA / EMA
ANVISA TGA