Pegasus Farmaco India Pvt Ltd is a quality driven pharmaceutical manufacturing and marketing company with an over a period of 16 years. Pegasus Farmaco has two state of the art manufacturing units for manufacturing quality formulations in Tablets, Capsules, Ointments forms. Apart from its ethical marketing of its own brands with an established marketing and distribution setup, the company has also rich experience in offering Contract manufacturing Services. Pegasus Farmaco provides excellent work and growth environment to people and work culture that allows its members the space to learn, innovate, experiment and grow
Post: QA-Manager
Job Description:
Responsible for the entire activities of the Quality Assurance Department, that include the following:
To review the Batch manufacturing record after completion of packing of batch.
To investigate the market complaints and to maintain record.
To review the stability protocol.
To conduct the Training programs.
To report the daily activities to QA manager or Reporting authorities/management
Ensuring Quality of products as per specification.
Ensuring preparation of SOP’s for all mfg.process of each department.
Validation of process, analytical methods, machines, air handling units, water, utility, cleaning processes. Master validation plan. Revalidation in case of any changes.
Risk analysis.
Ensuring quality standards for all incoming material inspection like RM, PM, water, air ,nitrogen, oxygen,steam etc. pre-dispatch inspection and online inspection.
Internal Auditing of each departments as per schedule.
Asst in Handling customer, FDA,WHO,GMP, ISO , third party and Vendor Audit.
Ensure implementation of all ‘’SOP’’ with co – ordination with concern deptt.
Responsible for corrective and preventive action for customer complaint & other Non compliances, deviations and out of specification(oos). Root cause analysis of above.
Calibration & validation of all measuring instruments & equipments/machines.
Prepare annual product review and statistical trend analysis for the data.
Informing any Non confirming of product to superior.
Preparation of (MFR) manufacturing formula records for new products or review products.
Batch card issue & release and final product release in absence of asst. QA manager.
Ensuring that there is no (NC) non compliance in any audits.
Training to Employee for on job training, SOPs and Quality management system, GMPs, WHO standards.
Documentation of all Quality records.
Evaluating change control/deviation for the specification and test method & Mfg. Process.
Review of environment monitoring and trending.
Review of water systems and trending.
Control of all documents like batch cards, MFR, BMR and all related documents.
Validation of computer systems, ERP and password control for QA/QC computers, back up of data on computer.
Carry out vendor audit as and when required.
Calculation verification of active raw material before manufacturing in absence of superior.
Art work approval in absence of superior.
Proper storage and retrieval of BMRs.
Preparation of product files(MFR,PV/AMV/stability data and APR)
Candidate Profile:
B.Sc/B.Pharm with (5-10) yrs of exp. in handling Quality Assurance for pharmaceutical formulations (Tablet, Capsule, Ointments) experience in WHO-GMP, UKMHRA/ USFDA approved units is prefered
Contact Details & Job Location:
Location of the Post: 29, IDA, Bhongir, Dist: Nalgonda, Andhra Pradesh
Interested candidates may send their resume to hr.pfipl@yahoo.com
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