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Engineering Head - API
Sun Pharmaceutical Industries
posted 2hr ago
Job Role Insights
Flexible timing
Job Description
Qualification: B.E. / B.Tech (Mechanical)
Experience: 20+ years of API industries experience in the field of engineering services of Plant & Utility maintenance
Responsibilities :
1) Monitoring for Documents compilation activities for New product filing , Re-Registration/renewals from plant dossier filing , sample requirements etc.
2) Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data/documents from plant.
3) Coordination with CRA, ADD, FDD, MSTG ,PMO ,Plant team and with other CFT Members for regulatory requirements related to Registration, Re-Registration, queries, and variation filing.
4) Product Life Cycle Management: Active participation in Change control committee meeting. - Discussion with different Stakeholders and decision for final variation category (After taking concurrence from CRA, Country RA and Customers if require).
5) Activities related to Variation management - Tracking of Variation filing, approvals and intimation to plant for implementation of changes.
6) Support plant for business continuity of products by filing variations wherever applicable.
7) Monitoring for circulation of Regulatory Approvals and commitment details to Plant Team for US and OAM and Approval package for emerging market.
8) Participation in all launch discussions with plant CFT , business team , CRA to identify gap & mitigation plan.
9) Circulation of Regulatory strategies and Guidelines, wherever applicable
10) Support plant during Regulatory Inspections.
11) Monitoring for Product permission s, test licences and lay out archival activities for Local FDA .
Employment Type: Full Time, Permanent
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People are getting interviews at Sun Pharmaceutical Industries through
People are getting interviews through
(based on 246 Sun Pharmaceutical Industries interviews)
Walkin
Referral
Job Portal
Company Website
Campus Placement
Recruitment Consultant
23%
22%
18%
16%
3%
2%
16% candidates got the interview through other sources.
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Confidence
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What people at Sun Pharmaceutical Industries are saying
Rating based on 2 Head Engineering
reviews
Anonymous · Engineering
in Paonta Sahib, Himachal Pradesh
Likes
Cost consciousness
Dislikes
Low budgetary support
Read 2 reviewsHead Engineering salary at Sun Pharmaceutical Industries
reported by
7
employees
with 16-33
years exp.
₹15
L/yr - ₹32
L/yr
41%
less
than the average Head Engineering Salary in India
View more details
What Sun Pharmaceutical Industries employees are saying about work life
based on 5.6k employees
Flexible timing
Monday to Saturday
No travel
Day Shift
Sun Pharmaceutical Industries Benefits
Submitted by Company
Health Insurance Job Training Free Transport Soft Skill Training
Submitted by Employees
View more benefits 
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Sun Pharmaceutical Industries Mumbai Office Location
Mumbai, Maharashtra Office
Headquarter
Sun House, CTS No. 201 B/1,, Western Express Highway, Goregaon East, Mumbai, Maharastra 400063, IN
Mumbai, Maharashtra
400063
400063
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