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168 Sun Pharmaceutical Industries Jobs

Manager

10-15 years

₹ 8.34 - 19L/yr (AmbitionBox estimate)

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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.

Vadodara

1 vacancy

Manager

Sun Pharmaceutical Industries

posted 3mon ago

Job Description

  • Responsible for lifecycle management of development products with respect to knowledge management and lifecycle management as per ICH. Management of process changes in early phase development
  • Review of clone development and cell banking documentation and ensuring regulatory compliance in plans and reports
  • Review of product development documents such as process development reports, process descriptions, process control strategy documents etc.
  • Review of analytical developments such as method development reports, method qualification/validation protocols and reports and ensure compliance as per latest quality and regulatory requirements
  • Development, Implementation and continual improvement of Quality Management System at R&D through SOPs, Manuals, training and audits and ensuring alignment with corporate QA and site QA.
  • Verification of Laboratory data and its integrity, ensuring good documentation practices and data reporting as per ALCOA++
  • Compilation and review of process and analytical documents for regulatory filing and CMC review
  • Control of documents, issuance of working copies, verification of raw data and archival of soft and hard copy documents based on ALCOA+ principles.
  • Knowledge on regulatory requirements on Biosimilar and biologics product specially USFDA, EMEA, Japan and India etc.
  • Experience in dossier writing for various countries such as USFDA, EMEA and India etc.

Key responsibility would be to ensure Dossier writing, Audit readiness at all times and defending QMS and ability to respond to Audit queries from Regulatory agencies, Clients and business partners.

Education and Experience:

  • MSc in life sciences / M. Pharm (Quality)
  • Minimum experience of 10 - 15 years in quality assurance
  • Good understanding of regulatory guidelines (RCGM, CDSCO, ICH and ISPE)
  • Exposure of product development, analytical development, CMC, regulatory filing, RCGM and CDSCO requirements for recombinant products. Exposure of filing in regulated markets (EMA/FDA/PMDA/TGA/HC/ANVISA) would be preferred.
  • Exposure to lifecycle management for global product development would be added advantage.
  • Experience of having faced international inspections / audits from Regulatory agencies, Clients and business partners is preferred.
  • Excellent skill of Verbal and Written communication in English is necessary.
  • Experience of Dossier writing.

Employment Type: Full Time, Permanent

Read full job description

Sun Pharmaceutical Industries Interview Questions & Tips

Prepare for Sun Pharmaceutical Industries Manager roles with real interview advice

Top Sun Pharmaceutical Industries Manager 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

4.1
 Rating based on 135 Manager reviews

Likes

It's phenomenon as of now

  • Salary - Good
  • +4 more
Dislikes

I would comment on curent appraisal system. If it would rework on this part ...its phenomenon for an employee and employer relationship.

Read 135 Manager reviews

Manager salary at Sun Pharmaceutical Industries

reported by 823 employees with 7-23 years exp.
₹6.7 L/yr - ₹23.4 L/yr
5% less than the average Manager 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
View more benefits

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