Executive - Quality Assurance

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

Job summary

Piramal Pharma Solutions is seeking an Executive - Quality Assurance to ensure GMP documentation review, process and cleaning validation, QMS management and regulatory compliance activities. You will review BMR, ECR and Analytical Raw Data, QC data and MMF, and support SOPs across departments.

The role includes initiating QMS activities such as Change Control and CAPA and ensuring timely EHS-related tasks. As part of the QA team, you will report to the HOD and contribute to continuous

Qualifications

• QA professional experienced in GMP documentation review
• Process and cleaning validation experience
• QMS management (Change Control, Deviation/Event, CAPA)

Responsibilities

• Review of BMR, ECR and Analytical Raw Data
• Review of QC Analytical data
• Preparation and Review of BMR, ECR, MMF
• Preparation and review of Process validation protocol and Report
• Monitoring of process validation and Annual Product Review
• Prepare SOPs for cross-functional departments
• Handle Cleaning Validation and Dispatch activities
• Initiate QMS activities like Change Control and CAPA

Job description

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.

Job Title Executive - Quality Assurance

Job Description QA professional experienced in GMP documentation review, process and cleaning validation, QMS management (Change Control, Deviation/Event, CAPA), analytical data review, SOP management, and regulatory compliance activities. Review of BMR, ECR and Analytical Raw Data. Review of QC Analytical data. Preparation and Review of BMR, ECR, MMF. Preparation and review of Process validation protocol and Report. Monitoring of process validation. Preparation of Annual Product Review. Preparation and review of SOPs of Cross Functional Department. Handling Cleaning Validation. Handling Dispatch and line clearance activity. Initiation of QMS related activities like Change Control, Event and related CAPA. To ensure the EHS (Environmental Health and Safety) related activities to be completed on time and to support EHS activity as per requirement. To report near miss and incidences as observed as per EHS requirement. Any other work assigned by HOD.

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.

For more details, please visit : www.piramalpharmasolutions.com