Executive - QA

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

Compliance to the instructions given in Batch records of various products.

Ensuring the compliance of the SOPs and cGMP requirements at shop floor.

Ensuring no mix-ups, contamination and cross contamination of the products during all stages of manufacturing means of “Line Clearance” and continuous monitoring the process.

Performing “In-process Checks” at different stages of manufacturing for various products and ensuring the compliance.

“Sampling” at different stage of manufacturing or as per the requirement.

Stage wise review of batch records and compliances if any, to facilitate timely release.

Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification.

Review of master batch manufacturing record and batch packing record in SAP

Active participation in execution of Qualification and calibration activity.

Periodic review and preparation of APQR.

Handling of CAPA, Change controls, OOS, OOT, Laboratory Incidence, Market complaint & Deviations through QAMS.

Co-ordination & execution of Self Inspection and compilation of self-inspection observations.

Active participation in investigation related to product / system failure.

Ensuring the awareness of cGMP and its requirement to the technicians/concerns through continuous interaction/SOP training.

Active Participation in Batch Release Activity.

Active participations in all the IPQA activities.