SYNGENE
Career Opportunities Manager
Responsible
for the implementation of Labware LIMS application and ELN in QC and Stability business verticals.
2. Responsible for developing and maintaining
data management systems, 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
3.Responsible
for defining the application landscape & configuration management.Responsible
for driving delivery of project using PMP methodologies (Project Delivery
Framework based on PMI standards).
4. Responsible for working towards agreed
objectives & timelines, while maintaining flexibility to take account of
new challenges and changed circumstances, as they occur.
5. Responsible for Interaction with cross
functional team IT, QC, Business user in order to ensure the LIMS configuration
as per the requirement.
6. 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.
7. Candidate should have strong experience and
knowledge on handling and monitoring non-routine QC activities like
Calibration, Standard Management and Compliance & Instrument management
8. 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.
9. Candidate should have depth technical
knowledge of investigation and closure of deviations, Incidents, out of
specification, change control and Out of calibrations
10. Candidate should be certified from Labware in
administrator training and should be able to configure and customize system the
system as per the requirement.
11. Candidate should have minimum two
successful implementation exposure in Pharma-Life science domain.
12. Candidate should be well versed with the
Pharmaceutical domain API, QC, Stability, formulation.
13. Candidate should have strong knowledge on
defining the process and validate the LIMS application against the process.
14. Candidate should have configuration
exposure of SAP QMIDI (Quality Module Inspection Data Interface) with QM and MM
modules exposure.
15. Candidate should have strong knowledge on
complete life cycle of Lot management including the Inventory, stock and
disposition process.
16. Candidate should have strong knowledge on
Instrument Management - Calibration, PM and external calibration process.
17. Candidate should be experienced with the
system administration and maintenance activities of the LabWare LIMS
application.
18. Candidate should have strong experience in
designing the system architecture, size the systems, help to estimate costs,
and implement the solution.
19. 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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