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13 Sun Pharmaceutical Industries Manager Jobs

Manager- CMO

15-18 years

₹ 8.5 - 22.07662L/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.

Mumbai

1 vacancy

Manager- CMO

Sun Pharmaceutical Industries

posted 2mon ago

Job Role Insights

Flexible timing

Job Description

Position: Manager 2 - CMO

Department: Corporate Quality

Location: Mumbai/ Baroda

Reporting Manager Title: DGM- CMO

Job Summary:

  • Accountable for quality oversight of contract manufacturing organizations responsible for manufacturing of site transfer products (Sun site RD) for US market.

Essential Job Functions:

  • Regular oversight visits of the CMO sites for review of process practices and accordingly prepare visit reports.
  • Coordinate with Sun site, commercial, corporate quality audit the CMO site as SPOC for activities related to product manufacturing and release and other technical issues.
  • To author and review quality agreements between Sun Pharma CMO site. Also, ensure qualified and approved external service providers are used.
  • To ensure presence and participation during manufacturing for process validation batches to ensure that the manufacturing process as per the approved BMR is followed.
  • To witness testing of process validation batches including hold time studies and in-process testing are conducted as per the approved specification, test procedures protocols.
  • Review of quality system documents, facility equipment s, manufacturing packing controls, labelling laboratory controls at the CMO site at regular intervals.
  • Cause based /routine visits to CMO sites (with reference to Market Complaints/Recalls/CAPA implementation and effectiveness check)
  • Review of batch manufacturing packaging records, analytical reports and COA/COC for batch release. And release of batches in SAP.
  • Review of stability data, process validation report, analytical method validation report, specification/STP of FP, API COA, primary packing material COAs, approved vendor of RM/PM, APQR etc.
  • To review quality system documents such as change controls, deviations, CAPA, OOS/OOT, product quality complaints, Recalls etc.
  • Prepare review SOP s as per Sun Pharma quality standards.
  • Prepare approved vendor list for raw materials and primary packaging materials for the product to be manufactured at the CMO site.
  • To prepare annual risk assessment of the CMO sites.

Requirements and Qualifications:

  • M.Sc./ B. Pharm / M. Pharm or equivalent.

Industrial Experience Knowledge:

  • Total 15-18 years of experience in Quality Control, Quality Assurance, Quality and compliance, in sterile formulations manufacturing.
  • Knowledge of GMP s in both domestic and international regulatory environments. In-depth knowledge of FDA guidance s such as ICH is must.
  • Strong organizational, interpersonal and communication skills.
  • Ability to work effectively in multicultural matrix organization


Employment Type: Full Time, Permanent

Read full job description

Sun Pharmaceutical Industries Interview Questions & Tips

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What Manager 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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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
400063

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