Sr. Executive

Lupin; Chhatrapati Sambhajinagar District; On-site; INR 600,000 - 900,000; Full time

Job summary

Lupin in Maharashtra, India is seeking a QA/QMS Analyst to support quality systems documentation and SOP development. You will review critical quality documents and participate in QAMS activities including change control, OOS, OOT, deviations, lab incidences and CAPA.

You will also review batch manufacturing records, batch packing records and validation/qualification documents, ensuring timely closure of investigations and adherence to regulatory standards.

Qualifications

• Experience in handling QMS documents and change controls.
• Familiarity with OOS/OOT investigations and CAPA processes.
• Review of batch manufacturing and packing records.
• Knowledge of validation and qualification documentation.
• Ability to review and close market complaints investigations.

Responsibilities

• Review of various quality system documents.
• Preparation and review of Standard Operating Procedures.
• Handling of QAMS activities like change control, OOS, OOT, Deviations, Lab Incidences and CAPA etc.
• Preparation and review of quality risk management.
• Review of batch manufacturing record and batch packing records.
• Review, assessment and closure of other QAMS documents whenever required.
• Review of validation and qualification documents.
• Handling of market complaint and participate in investigation.

Skills

Quality systems

SOP review

QAMS

CAPA

Job description

• Review of various quality system documents.
• Preparation and review of Standard Operating Procedures.
• Handling of QAMS activities like change control, OOS, OOT, Deviations, Lab Incidences and CAPA etc.
• Preparation and review of quality risk management.
• Review of batch manufacturing record and batch packing records.
• Review, assessment and closure of other QAMS documents whenever required.
• Review of validation and qualification documents.
• Handling of market complaint and participate in investigation.