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

           Apply | Print | Forward to a Friend