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Deputy Manager - IT CSV
Piramal Pharma
posted 17hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Candidate with 3 - 5 years of experience in Pharma/Life science domain working knowledge in authoring on Computer System Validation Deliverables, Part 11/Annex 11, Data Integrity
Work experience in Pharmaceutical Sector will be desirable
SKILLS AND COMPETENCIES
Experience in Authoring all CSV deliverables eg URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc.
as per V Model for IT projects
as per V Model for IT projects
Experience on validation of any of the enterprise level applications.
eg Trackwise, Ensur/Documentum, LIMS, LMS, SAP/HANA, Chromatographic, Serialization, etc.
eg Trackwise, Ensur/Documentum, LIMS, LMS, SAP/HANA, Chromatographic, Serialization, etc.
Author, review and approval of SOPs, Guidelines/Policies as applicable.
To have functional knowledge of Regulatory guidelines, Quality and Manufacturing processes.
A team player with good communication skills (verbal & written)
To have thorough understanding, practical approaches for Computer system validation (CSV) of enterprise level applications.
Accountable to ensure compliance of CSV documentation during various phases (project, operational & retirement) of software lifecycle (SLC).
Well aware with GAMP5, CFR Part 11/EU Annex 11 and Data integrity requirements.
Well aware with GAMP5, CFR Part 11/EU Annex 11 and Data integrity requirements.
To create infrastructure ((Network, Servers, Cloud, Database) qualification documentation.
To create QMS documents eg Change control / Deviation / Incidents-Discrepancy / User access forms.
To perform Root cause analysis and define CAPA based on QMS documents review.
To perform periodic and audit trail review of computerized systems as per defined frequency.
To support the initiatives undertaken by Quality eCompliance and CSV team across the Corporate/PEL sites.
Perform IT Supplier assessment and ensure compliance of audit observations.
To liaise with Site ITC SPOC s for CSV activities and IT Compliance initiatives.
To guide and train IT & CSV teams (Corporate & Site) for CSV, Data Integrity and Regulatory Compliance activities.
Knowledge of IT systems and ITIL processes (eg Backup/Restoration, Infrastructure qualification, User access Management, etc.
)
)
Ability to represent during regulatory audits and can able to perform Corporate & DI Audits of sites.
To work along with CSV & Project Manager to ensure project timelines are met.
Knowledge Required:-
Good knowledge of 21 CFR Part 11 / Annexure 11 (Must)
Good knowledge of CSV, GAMP 5 (Must)
Good knowledge of Data Integrity requirements for Pharma (Must)
Experience of working at Pharma Site - QC, QA, IT, CSV etc.
(Plus)
(Plus)
Experience of validation on automation/digitization projects (Plus)
Good Verbal and Written communication skills (Must)
Good Knowledge on Computer Software Assurance
Aware of industry best practices and knowledge about Pharma 4.
0 (Plus)
0 (Plus)
Functional knowledge of Regulatory guidelines, Quality Control and Manufacturing processes.
(Plus)
(Plus)
Knowledge of IT systems and ITIL processes (eg Backup/Restoration, Infrastructure qualification, User access Management, etc.
) (Must)
) (Must)
QUALIFICATION:
Graduate in Science/Pharmacy/Engineering
Post Graduation - Science/MBA (Desirable)
Employment Type: Full Time, Permanent
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What people at Piramal Pharma are saying
Deputy Manager Information Technology salary at Piramal Pharma
reported by
4
employees
with 2-6
years exp.
₹8.4
L/yr - ₹9.6
L/yr
12%
less
than the average Deputy Manager Information Technology Salary in India
View more details
What Piramal Pharma employees are saying about work life
based on 961 employees
Flexible timing
Monday to Saturday
No travel
Day Shift
Piramal Pharma Benefits
Submitted by Company
Free Transport Soft Skill Training Job Training Health Insurance
Submitted by Employees
View more benefits 
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