Executive - Quality Control

Piramal Pharma Limited; Hinoba-an; On-site; PHP 480,000 - 720,000; Full time

Job summary

Piramal Pharma Limited is seeking an Executive - Quality Control to lead microbiology lab activities and ensure compliance with cGMP and SOPs. The role involves microbiological testing of finished products, starting materials, and stability samples, along with media preparation and instrument calibration.

Candidates will monitor lab conditions, maintain online documentation, and report deviations with corrective actions.

Qualifications

• Experience in microbiology laboratory operations.
• Knowledge of cGMP regulations.
• Ability to document and report microbial data.

Responsibilities

• Operate and maintain microbiology testing of finished products, materials, and samples.
• Ensure cGMP compliance and local SOP adherence.
• Prepare media, GPT, and perform sampling/analysis.
• Monitor temperatures and calibrate instruments.
• Document deviations and corrective actions.
• Ensure online documentation and data reporting.

Skills

Microbiology

cGMP compliance

Documentation

Analytical testing

Tools

Laboratory instruments

Job description

About the Company

Be the First to Apply 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

Executive - Quality Control

Job Description

JD - Executive (Microbilogist)

• Ensure effective functioning of Microbiology Laboratory by carry out analysis
• Ensure the compliance to cGMP regulations, quality guidelines and local SOPs.
• Ensure online documentation. Planning and execution of Microbiological activities & online documentation.
• Microbiological testing of finished product, starting material, stability sample, R & D sample.
• Microbiological media preparation and its GPT.
• Daily monitoring of Area / room & refrigerator/ Incubators temperatures, Microbiological monitoring of classified areas.
• Bacterial culture maintenance and keeping records of consumption of ATCC/NCTC cultures.
• Sampling & Analysis of water samples for microbiological parameters.
• Analysis of compressed air and nitrogen gas.
• Report all deviations, which may have impact on safety, identity, strength, purity & quality of drug substance/ product.
• Issuance of QC analytical data sheets Trending & review of microbial analytical data for water samples, RM, FG samples.
• Monitoring & perform the calibration / validation for Instruments / Equipment in micro-Lab.
• Preparation and destruction of Media and culture.
• Preparation of Microbial inoculum.
• To perform safe Laboratory operations (as per MSDS) ensuring proper usage of PPEs
• To ensure work permit system during maintenance activities.
• To perform Autoclave validation.
• To carryout in-house Microbial flora isolation process.
• To perform fogging activity as per schedule.
• Daily review & prints out of Incubator when it required.
• To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same.
• To perform Microbial assay.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL's associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.