cGMP Quality Assurance Specialist

Lupin; Hinoba-an; On-site; PHP 300,000 - 540,000; Full time

Job summary

Lupin is seeking a QA/compliance professional to ensure adherence to SOPs and cGMP on the shop floor. The role covers batch records review, line clearance, in-process checks, sampling and timely release of products.

Responsibilities include validation activities, SAP record reviews, CAPA handling, self-inspections, and investigations related to deviations or failures. Training staff on cGMP is also essential.

Responsibilities

• Compliance to batch records and cGMP requirements on the shop floor.
• Ensure no mix-ups, contamination, or cross-contamination during manufacturing; implement line clearance and continuous process monitoring.
• Perform in-process checks at different stages for various products and ensure compliance.
• Sampling at various stages of manufacturing as required.
• Stage-wise review of batch records and compliances to facilitate timely release.
• Prepare, execute and compile process validation (PPQ) and cleaning validation & cleaning verification.
• Review master batch manufacturing records and batch packing records in SAP.
• Participate in qualification and calibration activities.
• Periodic review and preparation of APQR.
• Handle CAPA, change controls, OOS, OOT, laboratory incidences, market complaints and deviations through QAMS.
• Coordinate and execute self-inspections and compile observations.
• Participate in investigations related to product/system failures.
• Ensure awareness of cGMP and training for technicians through SOPs.
• Active participation in batch release and IPQA activities.

Job description

Lupin is seeking a QA/compliance professional to ensure adherence to SOPs and cGMP on the shop floor. The role covers batch records review, line clearance, in-process checks, sampling and timely release of products.

Responsibilities include validation activities, SAP record reviews, CAPA handling, self-inspections, and investigations related to deviations or failures. Training staff on cGMP is also essential.