CIEL/SEL/23489: Quality Assurance Manager

  Regulatory Affairs

Job title: CIEL/SEL/23489: Quality Assurance Manager

Company: CIEL HR Services

Job description: Designation:Quality Assurance Manager

No. of Position: 1

Job Location: Jambusar , Vadodara

Experience Range: 5 to 10 Year

Reporting to: Manager

Qualification: M.Sc (Chemistry)

Job Location: Gandhinagar, Gujarat

About company: Client of CIEL HR, A leading Agro Chemical Manufacturing Company.


Job requirement:

ob Discription :

· Data approve for analytical method validation, technology transfer, and analytical method verification.

· Review and approve of validation and qualification documents.

· Ensuring the Good laboratory practices compliance.

· Review and approve of Laboratory investigation reports.

· Approve of analytical reports for release.

· Approving the scientific rationale for the hypothesis & subsequent experiment for non-conformances.

· Daily auditing in laboratory, good documentation practices, good chromatographic practices to assure the regulatory compliance.

· Trends for OOS, OOT, Analytical incidences etc.

· Work allocation, sampling planning, analysis planning, review and approve.

· Compliance of documents, electronic data, and log books for Analysis.

· Approve SOP, Specification and STP, analytical document of Raw Material, Packaging Material, Semi Finish & Finish Product, and Calibration Report of analytical instrument.

· Approving trend data, maintaining records, monitor timely submitting the reports to Quality Assurance.

· Getting in line with the pharmacopoeia changes, setting up new methods as per the current changes.

· Communication to all concern Departments for effectiveness of the results for the organization.

· Attending queries of Drug Regulatory affairs.

· Method validation and Review validation and revalidation.

· Qualification of new analysts.

· Reviewer and approver for investigation of Incidents and Deviations

· To handle Root cause analysis and implementation of the CAPA.

Kindly share your profile at below:

Krupa Patel (

Mob no: 7227020068

Expected salary:

Location: Vadodara, Gujarat

Job date: Sat, 05 Feb 2022 01:15:23 GMT

Apply for the job now!