At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an workplace where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Position Summary
This position shall be responsible for identifying, planning, conducting product pre approval inspection (PAI) at various Sun and Sun CMO sites (Formulation & API) from where product dossiers/DMF’s are submitted to the regulatory agencies in order to assure on time drug product/API approval.
Key responsibilities:
Plan and execute pre approval inspection for various products /API executed at Sun and Sun CMO sites from where dossiers/DMF’s are submitted
To understand manufacturing, packing process and analytical techniques development and execute audit plan.
Identify risk factors and ensure quality system is audited to identify risk. are mitigated and closed prior to pre-approval inspection by agency.
Assure identified risk are communicated to respective stakeholder for appropriate risk mitigation and closed prior to pre-approval inspection by regulatory agency.
Review various documents records and data generated during execution of technology transfer and submission batches inline to internal and regulatory requirements
Batch manufacturing/packing records, analytical records, qualification records, associated raw data, electronic records etc.
GMP documents associated submitted batches like Equipment Qualification, Process Qualification/Validation, Change Control, Deviations, Distribution, Batch r