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Senior Research Associate-AD @ Piramalpharma

Ahmedabad, Gujarat, INOnsiteFull-time
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Piramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Senior Research Associate-ADJob Description

Method validation and Verification activities. Ø Routine analysis of Clinical samples and Stability samples. Ø Cleaning verification swab sample analysis. Ø Preparation of technical documents. Ø To follow the compliance of the system within the department. Ø To perform calibration of various analytical instruments. Ø Review of routine analytical activities (Peer review)Follow GLP, GDP and Data Integrity practices while working in laboratory

Ø To perform sampling of raw material and packaging materials as per SOP.

Ø Routine analysis of Raw materials, packaging materials, In-process, finished products,

Cleaning swabs and Stability samples.

Ø To perform preventive maintenance and calibration of the analytical instruments as per calibration schedule.

Ø Preparation of technical documents like SOPs, specifications, COA, STP, Validation protocols/reports, Transfer protocols/reports etc.

Ø Archival and retrieval of system documents i.e. Instrument logbooks, Registers etc.

Ø Validation and Verification of analytical methods.

Ø Lab temperature monitoring.

Ø Follow GxP (GMP, GDP etc.) for all processes.

Reporting of analytical data and submit for review and release.

Ø Maintain hygienic condition in respective department.

Ø Standard, column and chemicals Management.

Ø Balance and pH meter/conductivity meter verification and calibration.

Ø Ensure use of Personal Protective Equipment & attend EHS training & send waste to concerned person & comply EHS requirements.

Skills

method validationData IntegrityPreventive MaintenancePeer review

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