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25 Intas Pharmaceuticals Jobs
GM -QA (IT-QA and Computer system Validation)
Intas
·
18-28 years
₹ 43 - 55L/yr (AmbitionBox estimate)
This is an estimate of the average salary range for this
position. It has not been reviewed by the company, and
the actual salary may differ.
Ahmedabad
1 vacancy
GM -QA (IT-QA and Computer system Validation)
Intas Pharmaceuticals
posted 7d ago
Job Description
- Experience/ exposure to Computerized System Compliance with respect to- US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
- Must have experienced in implementing technical controls across Manufacturing & Quality IT application e.g. Quality Management System, Document Management System, Electronic Batch Manufacturing Record System, Chromatographic Data System, Laboratory Information System, Environment Monitoring System, Data Acquisition System and QC Standalone System
- Must have experienced in executing IT System Remediation Plans across Pharma Manufacturing, Quality and Enterprise applications in large plant-set-up(Regulated)
- Must have experience in auditing business IT Application in terms of technical controls and data governance controls
- Must have experienced in carrying-out system (business application) inspection with respect to data governance and able to generate observation/gap report for corrective action plan. Must able to run periodic inspection plan for effective review mechanism of audit trail in various business application.
- To run independent assessment program and CAPA plan for computer system security and integrity across GxP computerized systems
- To have thorough understanding, practical approaches for Computer system compliance of enterprise level applications and standalone system used in Manufacturing and Quality.
- Prepare the Computer system validation Master Plan and maintain GxP computerized system inventory and system into their validated status.
- Hands on experience on process equipment computer system validation for new equipment and upgradation of existing process equipment to meet 21 CFR part 11 requirement ( i.e. Individual login and password , audit trail , alarm management , data back up and restoration etc. )
- To work along with QA Team and Business Project Manager in defining technical controls & compliance requirements and ensure project milestones are delivered as per timelines.
- Must have understanding of validation approach of pharmaceutical computerized systems used in GMP , GXP environments and able to work with various stake-holders for delivery of URS, FRS, CRA, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc.
- Must have worked in implementing effective review mechanism of various business applications Audit Trail’ data through ‘Review by exception’ Rule in order to enhance overall compliance on generated & reported data.
- Review Data Validation or Listing Specification document created by team. Closely work with other supporting departments to ensure all testing issues are resolved in a timely manner and study timelines are met.
Employment Type: Full Time, Permanent
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Referral
Company Website
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Recruitment Consultant
30%
26%
12%
8%
4%
2%
18% candidates got the interview through other sources.
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What people at Intas Pharmaceuticals are saying
Rating based on 3 General Manager
reviews
Anonymous · Customer Success
in Ahmedabad
Likes
All good
Dislikes
Nothing to mention as such
Read 3 reviewsGeneral Manager salary at Intas Pharmaceuticals
reported by
48
employees
with 14-29
years exp.
₹25.8
L/yr - ₹80
L/yr
35%
more
than the average General Manager Salary in India
View more details
What Intas Pharmaceuticals employees are saying about work life
based on 3.2k employees
Flexible timing
Monday to Saturday
No travel
Day Shift
Intas Pharmaceuticals Benefits
Submitted by Company
Free Transport Job Training Soft Skill Training Health Insurance
Submitted by Employees
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Intas Pharmaceuticals Ahmedabad Office Location
Ahmedabad, Gujarat Office
Headquarter
Intas Pharmaceuticals Ltd.
Corporate House, Near Sola Bridge, S. G.
Highway, Thaltej, Ahmedabad – 380054.
Gujarat. India.
Ahmedabad, Gujarat
380054
380054
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