Galentic Pharma (India) Pvt Ltd hiring for Officer/Senior Executive – Reviewer (Analytical Development)

Galentic Pharma (India) Pvt Ltd Walk-in Interview 2023. Galentic Pharma (India) Pvt Ltd Notification full details below.Intrested and eligible candidates can attend Interview on scheduled time and venue.Since over 30 years, Galentic has been manufacturing and supplying high quality pharmaceutical products. This includes both sterile and non-sterile range. The products are exported to over 40 countries – in the Private Market, Government Organisations and NGOs.

Vacancy details:

• Post Name: Senior Executive – Reviewer (Analytical Development)/ Officer Analytical Documentation

• Qualification: MS/M.Sc(Science) in Any Specialization, M.Pharma in Any Specialization

• Experienced:6-8 Years

Job Description: Greeting from Galentic Pharma (India) Pvt Ltd !!!!!

Important Details :

• Location: Mumbai (All Areas)

• Post of date:26/01/2023

• Selection Process: The selection will be on the basis of Interview.

• Mode of Interview: Face to Face interview

• Interview Rounds of Interview: HR

Job Position 1:

Designation – Senior Executive Reviewer (Analytical Development)

Experience – 6 to 8 years

Responsibilities:

• Experience into Analytical development documents and data review.
• Candidate is presently working as document/data reviewer and must have good skill of documents to be review for regulatory submission.
• Should have expertise in reviewing raw data including chromatograms (soft data as well as hard copies), lab notebooks, various protocols, reports etc. on line by following ALCOA principle.
• Sound understanding of validation activity and its documentation part of dissolution, assay and RS methods, qualification and validation of Instruments and Equipments, calibrations, recalibration, SOPs, transfer protocols and reports, Method development report, query response etc.
• Need to know about Empower software for data review and should have aware about audit trail system and monitoring of same on periodic basic.
• Strong belief in GLP/GDP and QMS includes review of deviations, incidences, CAPA and change control applicable during validation activity or during study.
• Should be able to guide team members for following GDP, GLP and in QMS.
• Need to know about internal audits and managing compliance part of it.
• Good initiator for implementing or upgrading process or system for effective data review for regulatory submission.
• Good training skills and team player.

Job Location –  Andheri East, Mumbai (R&D center)

Job position 2:

Designation – Officer Analytical Documentation

Department: Analytical Development – R&D

Experience: 3 to 5 years into documentation (Analytical)

Responsibilities:

Preparation of new and revision of existing Specifications, Standard Test Procedure and Record of Analysis for Finished Products as per the requirement for R&D.

Preparation, Numbering, Revision, Issuance and Control of ARD documents like Method of Analysis, etc.

Preparation of Standard Operating Procedures.

To assist Analytical Research Development team in the day-to-day functioning of the Analytical Development Laboratory.

To initiate and manage change control related to documents like Specification, STP and ROA preparation.

Maintenance of good laboratory practice and cleanliness in laboratory.

To update (self) with latest cGMP /GLP/Regulatory requirements.

Transfer protocols and reports.

Any other duties as per organizational requirements.

Job Location – Andheri East, Mumbai (R&D center)

Pharma Experience Candidates only apply.

Interested candidates apply at career@galentic.in