Pharma QA - Haridwar, India - KLINTOZ Pharmaceuticals Pvt. Ltd.

Description

You are Responsible for Quality Assurance and manufacturing activities at factory site.
II. You have to do follow up with the QC, Production, Store and other departments for
smooth flow of manufacturing work.
III. You have to attend all inspections organized by government departments or by
parties/clients. You have to update all the records required for Quality Assurance etc.
IV. You have to develop the trained staff and to establish proper team for production work.
You have to train the staff, motivate them as is needed for the betterment of the
company.
V. You have to achieve the target set by the top management at a schedule time and
develop a reporting system.
VI. You have to make projections to complete the work targets and should follow up with
the management and staff.
VII. You have to take care all the steps to take appropriate measures of quality assurance
activities as you are responsible for QA.
VIII. Training of chemist, supervisory and section managers for documentation, revised
and approval related to GMP, equipment's DQ,IQ,OQ and PQ, calibration, process,
SOPS, MFC, BMR, BPR, SMF, validation, qualification, verification, stability,
preventive maintenance plan etc.
IX. Validation of machine, area, process (DQ, IQ, IC, OQ & PQ) as well as
X. Qualification and calibration.
XI. To get unit approved by FDA, Uttarakhand and DCGI to get unit operational.

• To get factory inspected and licensed by FDA officials.
• Preparation for WHO GMP AUDITS and related documentation preparation.
• Liaison with all authorities during and start up of pharmaceuticals unit.

Coordinate with Regulatory deptt. Reg. completion of Dossiers in CTD, ACTD etc.
format for specific country's requirement, to submit for registration of the product in
that country.
XII. To prepare the specification for raw material, packaging material, finished products,
STP, SOP, BPR, BMR etc. of the product in correct form within the stipulated period,
whose dossier is being prepared.
XIII. Authorization of written procedures (SOPs) and other documents, including
amendments
- monitoring and control of manufacturing environment, plant hygiene
- process validation and calibration


Pay:
₹120, ₹200,000.00 per year


Benefits:

• Health insurance
• Provident Fund

Schedule:

• Day shift

Supplemental pay types:

• Yearly bonus
• Health insurance