Senior Executive - Quality Control

Piramal Pharma Limited; Pithampur; On-site; INR 600,000 - 900,000; Full time

Job summary

Piramal Pharma Solutions in India is seeking a Senior Executive - Quality Control (Microbiology) to perform environmental monitoring and microbiological testing across the manufacturing and lab environment.

The role emphasizes data integrity, ALCOA+ adherence, instrument upkeep, and participation in audits and CAPA with a focus on regulatory compliance.

Candidates will ensure timely sampling, testing and documentation to support GMP and ISO standards.

Qualifications

• Experience as a quality control microbiologist in a pharma setting.
• Ability to perform environmental monitoring and sterility testing per specs.
• Knowledge of cGMP, GLP and ALCOA+ data integrity.
• Experience with audits, CAPA and deviation investigations.

Responsibilities

• Perform microbiological environmental monitoring of manufacturing areas and labs.
• Conduct microbiological testing of raw materials, in-process and finished products.
• Maintain calibration and qualification of microbiology instruments.
• Ensure data integrity and timely data entry in laboratory systems.
• Support audits and investigations for OOS/OOT and CAPA.

Skills

Microbiology

Environmental monitoring

Sterility testing

GMP/GLP compliance

Data integrity

Tools

Laboratory instruments

Laboratory software (LIMS)

Job description

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 - Quality ControlJob DescriptionQuality Control _ MicrobiologistPerform 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.