Syngene Recruitment Junior Manager-Quality Assurance Apply Now
Syngene
Recruitment 2021.
Syngene
Notification full detailes below.Incorporated in 1993, Syngene International
Ltd. is an innovation-focused global discovery, development and manufacturing
organization providing integrated scientific services to the pharmaceutical,
biotechnology, nutrition, animal health, consumer goods and specialty chemical
industries around the world. Syngene’ s clientele includes world leaders such
as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife.
Important
Vacancy details:
A. Post Name:
Junior Manager-Quality Assurance
B.
Qualification:M.Sc., / M. Pharm
C.
Experience:5 + years of working experience with Pharmaceutical / Life science.
D.
Location:India-Bangalore
Job
Description:
Responsible for Preparation, review and
revision of QA SOPs using the Software EDMS.
Hiring For
Junior Manager-Quality Assurance in Syngene!
Handling change Management Systems for small
molecules of GMP functions.
Handling Quality Management System.
Supporting audit and compliance team during
audit.
Responsible to review and approve Analytical
method validation and Method transfer protocols/Reports.
Responsible to review computerized system
validation documents.
To support during client audits, regulatory
audits, vendor audits.
Conducting vendor audits.
Key
Responsibilities:
To review and handle change control,
deviation, and CAPA with respect to Quality under GMP aspects.
Preparation, review and revision of QA
Procedures.
Review of Engineering procedures and
documents.
Co-ordination and participation during
customer/third party cGMP audits, regulatory audits and internal quality
audits.
Evaluation of change control, verification and
implementation of the Corrective and preventive action.
Review of protocol and report within SLA and
ensure the compliance from the respective department.
Ensuring method transfer activity is followed
as per procedure
Responsible to Review of Analytical and
Cleaning Method validation, Process validation, Excel validations, Forced
degradations – protocols and reports.
Review of CSV related documents and ensure the
compliance from the respective department.
Verification of routine and periodic audit
trail and ensure the compliance from the respective department.
Review & approval of specifications.
Training Activities.
Document management.
Any other responsibility as assigned by Head
QA based on knowledge, Experience and learning.§
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