Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife.
Post : Junior Manager - Quality Control - API (15550)
Job Purpose :
This role involves in the implementation of Labware Lab Information Management System (LIMS) application including Instrument interface and electronic notebook in Quality Control.
Key Responsibilities
• Prepare the blueprint of implementation and contribute to designing with the help of inhouse and outsourced support.
• Should have experience in Preparation of URS and validation plan.
• Should have experience in Preparation of Functional, configuration and Design specifications.
• Should provide technical expertise and assistance in designing, testing and developing applications.
• Should have experience in Creation of detailed and comprehensive Test Cases/UAT/Protocol (OQ & PQ) on a thorough understanding of requirements specification and execution of (OQ & PQ) and update RTM.
• Should be able to provide L1 and L2 support for post implementation of LIMS, interface & ELN.
• Should have experience in Creation of Static Data in LIMS.
• Should assess customer requirement and ensuring that these are met before the release, (as business analyst)
• Should perform Exploratory testing and sanity testing as per need basis,
• Should be able to perform migration of LIMS Objects and Installation of configure package,
• Should be able to generate reports and database queries using SQL script,
• Responsible for developing and maintaining, configuration of LabWare LIMS and peripheral software - Review and develop laboratory functional requirements to effectively plan, design, and implement software solutions for new and existing LIMS projects - Work within the team to prioritize and resolve issues across systems Qualifications
• Responsible for working towards agreed objectives & timelines, while maintaining flexibility to take account of new challenges and changed circumstances, as they occur.
• Responsible for Interaction with cross functional team IT, QC, Business user in order to ensure the LIMS configuration as per the requirement.
• Responsible for taking any other job allocated by Head of the Department.
• Responsible for Review of Audit trail data.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
• Attend training on environment, health, and safety (EHS) measures imparted company
Candidate Profile
• B. Tech., (CS)/M.Sc., / M. Pharm with minimum 5 + years of working experience with Pharmaceutical / Life science.
• Candidate must have strong understanding on USFDA 21 CFR Part 11 requirements for electronic record & electronic Signature (ER/ES) specially on data security, integrity and compliance. And should be able to assess the application software W.R.T. 21 CFR Part 11 requirements and remediate the gaps if any.
• Candidate should have strong experience and knowledge on handling and monitoring non-routine QC activities like Calibration, Standard Management and Compliance & Instrument management.
• Candidate must have working experience on GxP QC & Manufacturing Systems - Administration, Security Policies & Configuration, Privileges & User Roles Management, Audit Trail Review, Date & Time Setting, and User Management (such as User Creation, Modify, Activate, Deactivate, Disable, Enable, Role assignment etc.); and maintaining their records as per SOP.
• Candidate should have depth technical knowledge of investigation and closure of deviations, Incidents, out of specification, change control and Out of calibrations.
• Candidate should be certified from Labware in administrator training and should be able to configure and customize the system as per the requirement.
• Candidate should have minimum two successful implementation exposure in Pharma-Life science domain.
• Candidate should be well versed with the Pharmaceutical domain API, QC, Stability, formulation.
• Candidate should have strong knowledge on defining the process (able to brainstorm the scenarios) and validate the LIMS application against the process.
• Candidate should have configuration exposure of SAP QMIDI (Quality Module Inspection Data Interface) with QM and MM modules exposure.
• Candidate should have strong knowledge on complete life cycle of Lot management including the Inventory, stock and disposition process.
• Candidate should have strong knowledge on Instrument Management – Calibration, PM and external calibration process.
• Candidate should be experienced with the system administration and maintenance activities of the LabWare LIMS application.
• Candidate should have strong experience in designing the system architecture, size the systems, help to estimate costs, and implement the solution.
• Candidate should have strong analytical aptitude and be able to analyze complex problems/requirements and be able to define functionally advanced IT solutions.
• Should have working exposure with respect to other software’s like trackwise, EDMS & LMS.
Additional Information
Job ID : 15550
Experience : 5 to 10 years
Qualification : B. Tech, (CS)/M.Sc., / M.Pharm
Location : Bengaluru, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Quality Control - API
End Date : 30th October, 2020
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