Senior Executive - Quality Control

Piramal Pharma Ltd; Dhar; Vor Ort; INR 600.000 - 900.000; Vollzeit

Zusammenfassung

Piramal Pharma Solutions is seeking a Senior Executive - Quality Control to oversee microbiology QC and environmental monitoring in our manufacturing environment. You will conduct testing of materials, water, and finished products, and maintain cGMP-aligned records.

The role requires rigorous data integrity, CAPA investigations, and active participation in audits to ensure regulatory readiness. Training and SOP adherence are integral to daily activities in this fast-paced CDMO setting.

Aufgaben

• Perform microbiological environmental monitoring of manufacturing areas and the microbiology laboratory.
• Conduct microbiological testing of raw materials, packaging materials, finished products, in-process samples, stability samples, and water samples per approved specifications and pharmacopeia requirements.
• Perform sterility testing of raw materials, packaging materials, and finished products with proper documentation.
• Maintain, calibrate, qualify, and monitor microbiology laboratory instruments and equipment, including incubators, as per approved schedules.
• Ensure timely sampling and microbiological analysis of purified water, potable water, and other utility water systems.
• Maintain laboratory documentation in compliance with cGMP, GLP, ALCOA+ principles, and data integrity requirements.
• Ensure timely data entry in the applicable laboratory software.
• Participate in internal, external, customer, and regulatory audits, ensuring audit readiness and regulatory compliance.
• Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and microbiological failures in coordination with the Head of Department, and implement CAPA.
• Monitor laboratory operating expenses and ensure effective utilization of laboratory resources and consumables.
• Implement and maintain laboratory systems and procedures in compliance with GMP, GLP, ISO 9001, ISO 14001, and other applicable regulatory standards.
• Monitor updates to pharmacopeia’s (IP, BP, USP, EP, and JP) and ensure timely implementation of relevant changes.
• Support the Site Data Integrity Compliance Officer (DICO) in promoting data integrity initiatives.
• Train newly joined personnel on microbiology laboratory procedures, GMP, GLP, SOPs, and data integrity requirements.
• Ensure adherence to SOPs, laboratory safety practices, and regulatory expectations.

Kenntnisse

Microbiology

Environmental monitoring

Sterility testing

Data integrity

Audit readiness

CAPA investigation

Laboratory documentation

GMP/GLP compliance

Tools

Incubators

Analytical instruments

Laboratory software

Jobbeschreibung

Division

Piramal Pharma Solutions

Piramal 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.com

Job Title

Senior Executive - Quality Control

Job Description

• Quality Control _ Microbiologist
• Perform microbiological environmental monitoring of manufacturing areas and the microbiology laboratory as per approved procedures.
• Conduct microbiological testing of raw materials, packaging materials, finished products, in-process samples, stability samples, and water samples in accordance with approved specifications and pharmacopeia requirements.
• Perform sterility testing of raw materials, packaging materials, and finished products while maintaining complete and accurate documentation.
• Maintain, calibrate, qualify, and monitor microbiology laboratory instruments and equipment, including incubators, as per approved schedules.
• Ensure timely sampling and microbiological analysis of purified water, potable water, and other utility water systems.
• Maintain laboratory documentation in compliance with cGMP, GLP, ALCOA+ principles, and data integrity requirements.
• Ensure timely and accurate data entry in the applicable laboratory software.
• Participate in internal, external, customer, and regulatory audits, ensuring audit readiness and compliance with regulatory requirements.
• Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and microbiological failures in coordination with the Head of Department (HOD), and implement appropriate Corrective and Preventive Actions (CAPA).
• Monitor laboratory operating expenses and ensure effective utilization of laboratory resources and consumables.
• Implement and maintain laboratory systems and procedures in compliance with GMP, GLP, ISO 9001, ISO 14001, and other applicable regulatory standards.
• Monitor updates to pharmacopeia’s (IP, BP, USP, EP, and JP) and ensure timely implementation of relevant changes.
• Support the Site Data Integrity Compliance Officer (DICO) in implementing and promoting data integrity initiatives and awareness.
• Train newly joined personnel on microbiology laboratory procedures, GMP, GLP, SOPs, and data integrity requirements.
• Ensure adherence to Standard Operating Procedures (SOPs), laboratory safety practices, and regulatory expectations.