Production Qms

2 weeks ago


Ahmedabad, Gujarat, India Zydus Group Full time
Division

  • OINTMENT FACILITY
  • Job posted on


Feb 02, 202
  • Employee Type
  • C-C7Confirmed-HO Staff
  • Experience range (Years)
  • 10 years 15 years

Basic Details:
-


Position title (if any):Production QMS**
Designation: Asst.
Manager/ Dy. Manager**
Reports to :Head of Department

Department:
Production

Location:
Zydus Lifesciences Limited, Changodar (Topical), Ahmedabad.**
Key Job Description:
  • To follow the cGMP with the available infrastructure.
  • To do the work as per cGMP and GDP.
  • Review of documentation
  • Review Batch Records and Standard Operating Procedure, Documents, Validation Protocol and review and approve.
  • Implementation of corrective actions and preventive actions.
  • To perform selfinspection, assist in failure investigation, market complaints investigation.
  • Handling of change control, deviation, CAPA and incident.
  • To investigation of product failure, system deviations.
  • Tracking of implementation of commitment to various audit observations including internal audit observations.
  • To inform department Head/plant head for any abnormalities i.e. deviations/events/safety events and for other daytoday activities and to participate in investigation activities.
  • Responsible for QMS handling Initiation/Closure and closure related to Production (CAPA, Track Wise)
  • Preparation of Risk assessment /Protocol
  • To maintain timeline for all concerned activity.
  • To ensure completion of activities as per requirement.
  • To coordinate and synchronize product measurement within the department.
  • To ensure compliances to all regulatory, internal audits.

2. Requirements

Qualification:
B. Pharm/M. Pharm

Years of Experience:
years

Experience / Exposure in:

Must have knowledge and experience in regulatory audit

Should have faced regulatory audits like USFDA, MHRA, MCC and ANVISA etc.

From which departments, people can apply:
Production
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