Syngene Quality Manager Post Vacancy – Apply Now
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Job Title: Manager
Job Id: 4934
Eligibility: MSc Chemistry
Job Description:
- Responsible for the implementation of Labware LIMS application and ELN in QC and Stability business verticals.
- Responsible for developing and maintaining data management systems, the 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 defining the application landscape & configuration management.Responsible for driving delivery of a project using PMP methodologies (Project Delivery Framework based on PMI standards).
- Â Responsible for working towards agreed objectives & timelines, while maintaining the 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.
- 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 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
- Â Candidate should be certified from Labware in administrator training and should be able to configure and customize system 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 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.
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