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175 Sun Pharmaceutical Industries Jobs

Engineering Head - API

20-25 years

Kolkata, Mumbai, New Delhi + 4 more

1 vacancy

Engineering Head - API

Sun Pharmaceutical Industries

posted 2mon ago

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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Prepare for Head Engineering roles with real interview advice

Top Sun Pharmaceutical Industries Head Engineering Interview Questions

Q1. How will you start RS method Development for known drug product?
Q2. What is peak purity and how it is calculated in hplc?
Q3. 1 - Which biological indicator use in autoclave validation at the time of RVSEB media cycle i.e. 115 C ?
View all 224 questions

What people at Sun Pharmaceutical Industries are saying

4.0
 Rating based on 2 Head Engineering reviews

Likes

Cost consciousness

  • Salary - Good
  • +4 more
Dislikes

Low budgetary support

  • Work satisfaction - Poor
Read 2 Head Engineering reviews

Head 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 5.8k employees
51%
65%
42%
97%
Flexible timing
Monday to Saturday
No travel
Day Shift
View more insights

Sun Pharmaceutical Industries Benefits

Submitted by Company
Health Insurance
Job Training
Free Transport
Soft Skill Training
Submitted by Employees
Health Insurance
Job Training
Free Transport
Soft Skill Training
Cafeteria
Child care +6 more
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Sun Pharmaceutical Industries Mumbai Office Location

View all
Mumbai, Maharashtra Office
Headquarter
Sun House, CTS No. 201 B/1,, Western Express Highway, Goregaon East, Mumbai, Maharastra 400063, IN Mumbai, Maharashtra
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