We care about the impact having on the people and places touched by our mission to improve health around the world providing wide range of world class products on affordable price! HiGlance Laboratories is participating to combat the World Health Organization’s priority diseases control programs.HiGlance Laboratories registered Office is situated in India’s capital New Delhi and many representative offices are established in national regions to give feedback and fast service to our customers.
Job Description –: Greeting from Higlance Laboratories Private Ltd !!!!
Important Details :
Walk In Interview Details
Date : 20th to 23 November
Time : 10.30 AM – 5.00 PM
Venue :E-11, 12 And 13, Higlance Laboratories Private, Li mited, Site-B, Upsidc, Surajpur, Greater Noida, Ga utam Buddha Nagar, Uttar Pradesh, 201306, NOIDA, Uttar Pradesh, India
Responsibilities: –
Ensure that all Internal, Central and Local Clinical laboratory activities comply with Good Laboratory Practices (GLP) regulations and guidelines. Stay current with regulatory requirements and industry standards related to GLP.
Assist in the planning and conducting of internal audits to assess compliance with GLP standards. Coordinate external inspections and audits from regulatory agencies, ensuring preparedness and timely responses to findings.
Oversee the creation and review of laboratory documentation, including SOPs (Standard Operating Procedures), protocols, and reports. Ensure that documentation is accurate, complete, and in compliance with GLP requirements. Ensure all TMF Lab related documentation are filed in a timely and accurate manner.
Assist in providing training and guidance to laboratory personnel on GLP principles, procedures, and compliance requirements. Ensure that all team members are informed and adhere to quality control measures.
Identify and assess potential risks related to GLP compliance. Develop and implement risk mitigation strategies to minimize the likelihood of compliance issues.
Drive continuous improvement initiatives within the quality control function. Collaborate with relevant stakeholders to implement changes that enhance overall laboratory efficiency and quality.
Effectively communicate with cross-functional teams, management, and regulatory agencies regarding quality control matters. Provide regular updates on compliance status, issues, and improvements.
Qualifications:
Bachelors Degree in a scientific discipline i.e. B. Pharma or M. Sc. (Chemistry)
Minimum of 5 years hands-on experience in Pharmaceutical operations, technical operations and/or quality operations
Minimum of 1 year experience with Document Control within a GXP environment, with specific familiarity with Trial Master File and Quality Management System controlled documents
Extensive knowledge of GLP, GCP and ICH
Demonstrated knowledge of document control systems, preferably electronic systems
Demonstrated understanding of ICH-GCP, and regulatory requirements as they apply to the Trial Master File
Cell and gene therapy experience preferred
Must be highly organized, an effective and proactive communicator verbally and in writing, have disciplined practices of maintaining electronic records in real-time, and be able to work independently.
Strong team orientation and passion for continuous self-development.
Experience in industry or in a startup industrial setting is preferred.
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