Executive - Quality Assurance

Piramal Pharma Limited; India; On-site; INR 420,000 - 600,000; Full time

Job summary

Piramal Pharma Limited is seeking an Executive - Quality Assurance to support batch records review and shop floor documentation, ensuring compliance with SOPs and GMP.

The role involves online review of BMRs/ECRs, housekeeping verification, deviation reporting, material storage checks, line clearance support, and ensuring proper packing and dispatch processes. Strong attention to detail and adherence to SHE guidelines are essential.

Qualifications

• MSc in science or related field.
• Experience with batch production records (BMRs) and ECRs.
• Familiarity with GMP, SHE guidelines and PPE usage.

Responsibilities

• Online review of BMRs and ECRs on the shop floor.
• Verify housekeeping records and log books on the floor.
• Ensure deviations are reported online and materials stored under defined conditions.
• Assist with line clearance activities and finished good packing verification.
• Ensure compliance with PPE, SHE guidelines and related safety procedures.

Skills

Quality Assurance

Documentation

GMP

Audit

Education

MSc

Job description

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 Assurance

Job Description

• Online review of the batch production records (BMRs / ECRs) in Shop floor.
• Verification of housekeeping records in shop floor and accessories management.
• Daily monitoring of plant observations and verifying the SOPs compliance in shop floor
• Verification of various log books for completeness in manufacturing / other areas.
• Ensure that deviations are reported online.
• Monitoring that the materials are stored at defined storage conditions and labelled appropriately.
• Identify and report the potential areas of contamination/ Cross contamination in the site.
• Responsible for documents issuance, receipt and review and support to dispatch activities.
• Responsible to attach in finished good packing activity and ensure the packing is done as per requirement.
• Handling of the line clearance activity.
• Reviewing the quality system documents.
• Attaining the FG sampling, product label and seal verification while dispatch.
• Review of the executed Batch Production records (BMRs / BPR / ECRs).
• Comply with SHE Guidelines, SHE Rules and Regulations comply with usage of PPE Wherever applicable.
• Observe unsafe acts and conditions and take corrective & preventive actions immediately.
• Report any incident/accident/near miss /illness to the superiors.
• Identify unsafe conditions and unsafe acts and report to superiors.

• Online review of the batch production records (BMRs / ECRs) in Shop floor.
• Verification of housekeeping records in shop floor and accessories management.
• Daily monitoring of plant observations and verifying the SOPs compliance in shop floor
• Verification of various log books for completeness in manufacturing / other areas.
• Ensure that deviations are reported online.
• Monitoring that the materials are stored at defined storage conditions and labelled appropriately.
• Identify and report the potential areas of contamination/ Cross contamination in the site.
• Responsible for documents issuance, receipt and review and support to dispatch activities.
• Responsible to attach in finished good packing activity and ensure the packing is done as per requirement.
• Handling of the line clearance activity.
• Reviewing the quality system documents.
• Attaining the FG sampling, product label and seal verification while dispatch.
• Review of the executed Batch Production records (BMRs / BPR / ECRs).
• Comply with SHE Guidelines, SHE Rules and Regulations comply with usage of PPE Wherever applicable.
• Observe unsafe acts and conditions and take corrective & preventive actions immediately.
• Report any incident/accident/near miss /illness to the superiors.
• Identify unsafe conditions and unsafe acts and report to superiors.

Master of Science (MSc)

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.