Job Information
Sun Pharmaceuticals, Inc Senior Manager - Quality Assurance in India
Sr. No.
Responsibilities
Frequency
1.
To plan and monitor the routine functions of Quality management system.
Continuous activity
1.
To co-ordinate, manage proper functioning of Quality Assurance with continuous support and co-operation with other departments in line with cGMP norms implementation with regulatory and statutory compliance.
Continuous activity
1.
To Participate and contribute in investigation & troubleshooting.
To ensure adequacy of investigation, root cause, CAPA and Impact analysis for Unplanned Deviation, Market complaints OOS & OOT.
Continuous activity
1.
Management of Field Alert Report (FAR) activity.
Continuous activity
1.
Handling ofQuality Alert and Recall activity.
Continuous activity
1.
To Co-ordinate, Review, Evaluation and Approval of
CAPA
Market Complaint
Monthly reports
Annexure, Attachments, Addendum, Amendments reports.
Plant SOP's & other GMP documents.
As and when required
1.
Regulatory /Customer audits:
- To coordinate with the cross functions at the site regarding audit schedule, Audit findings, corrective actions, Trainings and audit compliance report.
Continuous activity
1.
To Co-ordinate, Review, Evaluation and Approval of
Change Control
CAPA
Market Complaint
Monthly reports
Annexure, Attachments, Addendum, Amendments reports.
Plant SOP's & other GMP documents.
Break down maintenance report
As and when required
1.
Handling of QMS activities through Trackwise Software.
Continuous activity
1.
To co-ordinate, review, evaluate & approve protocols and reports of:
Process Validation
Cleaning Validation
As and when required
1.
To co-ordinate, review, evaluate & approve protocols and reports of Dadra I & II like
Equipment Qualification
HVAC qualification
Water System validation
PLC Validation
Cleaning Validation
Software validation
Temperature Mapping
As and when required
1.
Internal Audit/Self-inspection:
To co-ordinate & conduct internal audit/Self inspection.
To ensure internal audit/Self inspection are conducted as per annual planner.
To ensure adequate CAPA has been taken for all observation.
To ensure for Compliance with the cGMP norms.
As and when required
1.
Preparation/review of master documents like-
Site Master File
Validation Master Plan
Process Validation Master Plan
Cleaning Validation Master Plan
Equipment Qualification Master Plan
As and when required
1.
Handling of LMS for Training.
As and when required
1.
Documents Management through EDMS.
As and when required
1.
Any specific job assigned by Head Quality/QA based on experience and competency.
As and when required
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.