Job Description

We are hiring for the QC – Molecular biology reviewer position.
Location – Pune (Hinjewadi Phase 2 )

Role & responsibilities
Responsible for review of In-process samples analysis (Molecular biology techniques like, ELISA, R-PCR, SDS-Page) data in a timely manner to support ongoing manufacturing activities.
Responsible for review of batch release, stability, method validation, method transfer and other study data in a timely manner to support business requirements.
Responsible for the preparation of protocols for Molecular biology techniques like, ELISA, R-PCR, SDS-Page, reports and planning for execution of analytical method validation & verification activity in accordance with regulatory and quality requirement.
Responsible for preparation & review of the Standard Operating Procedures (SOPs), Standard Testing Procedures (STPs) and Specifications in accordance with regulatory requirements.
Responsible for ensuring compliance with the audit observations (Regulatory, customer and self-inspection) within the stipulated timelines in analytical section.
Responsible for handling of Quality Management System (QMS) elements including Out of Specification (OOS), Out of Trend (OOT), Change control, Deviations, Events and Laboratory incidents encountered during analysis, ensuring thorough investigation, documentation and timely resolution in compliance with regulatory requirements.
Responsible for preparation and review of Certificate of Analysis (CoA) for drug substance and other samples (as and when applicable).
Ensure timely calibration, AMC (Annual Maintenance Contract) and Preventive Maintenance (PM) of instruments and equipments in Quality Control laboratory as per schedule.
Responsible for the review of audit trail in the software to ensure data integrity and regulatory compliance.
Responsible for review of temperature mapping data, other laboratory logbooks and formats on a daily basis to ensure routine activities as per SOP requirement.

If interested, please share your profile on career@mjbiopharm.com