Piramal Pharma

CDMO and hospital generics, consumer health

Executive Microbiologist - Microbiology

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timePithampur Industrial Area, Pithampur, Madhya Pradesh, IndiaNo salary listedIn-person

About the Job

Requirements

Postgraduate qualification in Microbiology.
Approximately 4–6 years of experience in a Microbiology department.
Knowledge of microbiology laboratory procedures, approved specifications, pharmacopeia requirements, cGMP, GLP, ALCOA+ principles, data integrity requirements, GMP, ISO 9001, ISO 14001, and applicable regulatory standards.
Ability to conduct microbiological testing, sterility testing, environmental monitoring, and water-system sampling and analysis.
Ability to maintain, calibrate, qualify, and monitor microbiology laboratory instruments and equipment.
Ability to investigate out-of-specification results, out-of-trend results, deviations, and microbiological failures, and implement corrective and preventive actions.
Ability to maintain accurate laboratory documentation and enter data in applicable laboratory software.
Ability to participate in audits and maintain audit readiness.
Ability to train newly joined personnel on microbiology laboratory procedures, GMP, GLP, SOPs, and data integrity requirements.

Responsibilities

Perform microbiological environmental monitoring of manufacturing areas and the microbiology laboratory according to 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, according to 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 applicable laboratory software.
Participate in internal, external, customer, and regulatory audits, ensuring audit readiness and compliance with regulatory requirements.
Investigate out-of-specification results, out-of-trend results, deviations, and microbiological failures in coordination with the Head of Department, and implement appropriate corrective and preventive actions.
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 the Indian Pharmacopoeia, British Pharmacopoeia, United States Pharmacopeia, European Pharmacopoeia, and Japanese Pharmacopoeia, and ensure timely implementation of relevant changes.
Support the Site Data Integrity Compliance Officer 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, laboratory safety practices, and regulatory expectations.

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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 - Micro

Job Description

Executive Microbiologist, should be completed Post Graduation in Microbiology stream and having approx. 4-6 years experience in Microbiology department.

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.

About the Company

Piramal Pharma

CDMO and hospital generics, consumer health

Piramal Pharma is a diversified pharmaceutical group with three divisions: Piramal Pharma Solutions (PPS), Piramal Critical Care (PCC), and the Consumer Products Division (CPD). PPS operates as a contract development and manufacturing organization, providing development and manufacturing services across the drug lifecycle for clients in North America, Europe, and Asia through a globally connected network. PCC specializes in complex hospital generics, particularly inhaled anesthetics, serving markets in the USA, Europe, and over 100 countries. CPD leads consumer healthcare in India with brands such as Littles, Lacto Calamine, i-pill, Tetmosol, Polycrol, and Tri Activ, and the company serves pharmaceutical companies, hospitals, and consumers by leveraging its manufacturing scale and distribution network.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Maharashtra, India
Founded: 2020

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