Job Description
To support Head QA & Compliance in implementing the applicable quality modules and the related SOPs at the home office as well to the contract manufacturing sites / distribution centres
To review the quality systems at the contract manufacturing sites and ware-houses in line with ‘Novartis third party assessment standards’ and to ensure that the remediation plan is in place in case any gaps
Batch acceptance and SAP releases.
Stability management
To monitor change controls, planned & unplanned deviations, corrective and preventive actions ( CAPA), compliances in trackwise
Annual product quality review
To prepare & issue updated Raw Material & Finished Product specifications
Return product management
Document management
To support Head QA in,Market complaints investigation
Product optimization projects
Regulatory investigation
Technology transfer project
Investigation during product counterfeit incidences
Ensure Quality Assurance & Compliance at contract manufacturing sites / warehouses & co-ordination
Product stability management/APQR/Deviations /Change controls/Return product
Technology transfer/Audits/ visits /Complaints handling
Documentation/Training /reporting etc
Desired Candidate Profile
Please refer to the job description above
Key Skills
Key Skills
.
quality assurance, QA, Quality Audit, QACM, QFD, QFD Deployment, initial flow control, QS, Drawing review
Qualification
.
B.E/B.Tech
Additional Qualification
.
quality assurance, QA, Quality Audit, QACM, QFD, QFD Deployment, initial flow control,
QS, Drawing review
Industry
.
Pharmaceuticals/Drugs/Labs
Functional Area
.
Pharmaceuticals
Job Role
.
Quality Assurance/Control Manager
