• Save Job
  • 1 - 3 Years
  • Posted : above 1 month

Job Description:

Person who has a good understanding on the quality compliance (GxP) requirements in a biopharmaceutical development lab He / She believes in continuous improvement and is passionate about improving quality systems with a goal of achieving world class quality systems

Responsible for monitoring quality compliance in biologics development lab and creating new procedures / improving existing procedures for improving compliance
Coordinate with Development Quality Assurance (DQA) team in implementing DQA SOPs at Biopharmaceutical Development (BPD) lab
Primarily responsible for review of development protocols and reports including review of raw data in lab note books and instrument generated data Issuance of document numbers for protocols and reports as per the approved procedures
Issuance of batch numbers and batch records for execution Review of batch records
Responsible for periodic review of 21 CFR 11 controls implemented for instruments / equipment at BPD
Participates in investigation of deviations initiated at BPD
Archival of the approved documents Coordinate with DQA for managing archival done by an external agency
Responsible for maintaining the inventory of all the documents submitted for archival and the location of the documents
Act as training coordinator for BPD To coordinate for transition of paper based trainings to an online Learning Management System (LMS)
Responsible for managing trainings of new joinees in the department
Conducting compliance related trainings in the department
Responsible for issuance of annexures (of protocols and SOPs) to process and analytical teams for documentation
Responsible for performing SAP transactions for control on lab note books
Performs periodic audits to identify non-conformances and coordinate for implementation of CAPA
Responsible for providing response to internal and external audits conducted at BPD
Responsible for collection of data and analysing data patterns in operation excellence initiatives for improving document quality, reducing sample TATs, deviations , equipment breakdowns and CAPA
Responsible for issuance of document numbers for SOPs and maintain the SOP index
Responsible for issuance of equipment ids and logbooks for new equipment
Performs any other activities assigned by the Department head

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Biotechnology/Pharmaceutical/Medicine
Functional Area : Quality/Process Control
Role : Quality Assurance
Salary : As per Industry Standards
Deadline : 24th Mar 2020

Key Skills:

These free online tutorials may interest you

People who search this job also searched for the following Keywords

Salary trends based on over 1 crore profiles

View Salaries

All rights reserved © 2018 Wisdom IT Services India Pvt. Ltd DMCA.com Protection Status