Require Junior Manager in Quality Control at Syngene International Ltd
Post : Junior Manager – Quality Control – API
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.
• 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
• 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.
Job ID : 14964
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 : 20th October, 2020
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube