Senior Executive-QA

Piramal Pharma Limited; Ahmedabad District; Presencial; INR 600.000 - 900.000; Jornada completa

Descripción de la vacante

Piramal Pharma Solutions is seeking a Senior Executive QA to oversee document control and archival management, ensuring GMP-compliant documentation across the pilot plant. You will monitor retention samples, support in-process sampling, and maintain quality events within the QMS framework.

The role involves reviewing batch manufacturing and packaging records, preparing SOPs for the QA department, and delivering induction training to new staff to uphold data integrity and regulatory standards.

Formación

• Responsible for document control and archival management, including issuance, retrieval, and maintenance of GMP documents.
• Supports SOP preparation and training delivery within the QA team.
• Ensures data integrity and compliance with GMP requirements across pilot plant operations.

Responsabilidades

• Issue and control of GMP documents (SOPs, BMR, BPR, Formats, Logbooks).
• Manage archival and retrieval of documents.
• Monitor retention sample storage temperature.
• In-process sampling and line clearance in pilot plant.
• Review master and executed Batch Manufacturing Record and Batch Packaging Record.
• Prepare QA SOPs and provide Induction Training.
• Update QMS logbooks (change control, deviation, OOS).
• Ensure site-wide data integrity awareness and compliance.

Conocimientos

Document control

Archival management

GMP

QMS

SOP preparation

Training delivery

Logbook maintenance

Data integrity

Batch records

Quality events

Descripción del empleo

Be the First to ApplyDivisionPiramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.For more details, please visit : www.piramalpharmasolutions.comJob TitleSenior Executive-QAJob DescriptionResponsible for document control and archival management, including issuance, retrieval, and maintenance of GMP documents. Oversees retention sample storage monitoring, in-process and verification sampling activities, line clearance, and control sample management. Reviews batch manufacturing and packaging records and ensures compliance with quality systems and GMP requirements in the Pilot Plant. Supports the Quality Management System (QMS) through SOP preparation, training delivery, logbook maintenance, and management of quality events. Promotes and ensures data integrity compliance and awareness across site operations.Issuance and control of documents. (e.g. SOPs, BMR, BPR, Formats, Logbooks and LNBs).Management of Archival and Retrieval of documents.Monitoring of temperature for retention sample storageIn process sampling of Clinical batches, Sampling of Swab during cleaning verification, Line clearance in pilot plant, water sampling, management of control samples.To review master and executed Batch Manufacturing Record, Batch Packaging Record and other documents related to manufacturing/packaging activity.To ensure practices being followed in Pilot Plant are in compliance with the quality procedures of the site.Prepare SOPs related to QA Department.Impart Induction Training on topics and on which training has been taken.Updating of Logbooks related to QMS documents (change control, deviation, OOS).Ensure compliance and awareness of data integrity at site.