Executive QA

Piramal Pharma Limited; Navi Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Piramal Pharma Limited is seeking a quality compliance professional to join our Manufacturing QA team in Navi Mumbai. You will review BMR, ECR, MMF, QC data, and contribute to process validation documentation and annual product reviews, ensuring data integrity and adherence to cGMP/GDP standards.

Key responsibilities include validation monitoring, SOP reviews, QMS activities like CAPA, change control, and EHS support to ensure timely completion of activities and reporting of near-misses and

Qualifications

• Good knowledge of cGMP and GDP within pharmaceutical quality systems.
• Experience with BMR, ECR, MMF and analytical data review.
• Understanding of data integrity requirements in QC documentation.
• Familiarity with APR/PQR preparation and documentation.

Responsibilities

• Review of BMR, ECR and Analytical Raw Data.
• Review of QC Analytical data.
• Preparation and Review of BMR, ECR, MMF.
• Preparation and review of Process validation protocol and Report.
• Monitoring of process validation.
• Preparation of Annual Product Review.
• Preparation and review of SOPs of Cross Functional Department.
• Handling Cleaning Validation.
• Handling Dispatch and line clearance activity.
• Initiation of QMS related activities like Change Control, Event and related CAPA.
• To ensure the EHS (Environmental Health and Safety) related activities to be completed on time and to support EHS activity as per requirement.
• To report near miss and incidences as observed as per EHS requirement.

Skills

cGMP/GDP knowledge

Pharma quality systems

BMR/ECR/MMF data review

Data integrity awareness

Job description

Role & responsibilities

• Review of BMR, ECR and Analytical Raw Data.
• Review of QC Analytical data.
• Preparation and Review of BMR, ECR, MMF.
• Preparation and review of Process validation protocol and Report.
• Monitoring of process validation.
• Preparation of Annual Product Review.
• Preparation and review of SOPs of Cross Functional Department.
• Handling Cleaning Validation.
• Handling Dispatch and line clearance activity.
• Initiation of QMS related activities like Change Control, Event and related CAPA.
• To ensure the EHS (Environmental Health and Safety) related activities to be completed on time and to support EHS activity as per requirement.
• To report near miss and incidences as observed as per EHS requirement.

Preferred candidate profile

• Good knowledge of cGMP, GDP, and pharmaceutical quality systems.
• Experience in BMR, ECR, MMF, and analytical data review.
• Understanding of Quality Control analytical documentation and data integrity requirements.
• Familiarity with Annual Product Review (APR/PQR) preparation and documentation.