Senior Executive-QA

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

Job summary

Senior Executive-QA at Piramal Pharma Limited is responsible for GMP documentation, PPQ, SOP management and QMS activities across multiple processes. The role entails handling change controls, deviations, CAPAs, and customer complaints while ensuring regulatory compliance and traceability of data.

The individual will review BMR, ECR and SOP in Ensur Software and participate in cleaning validation, dispatch, and line clearance tasks.

Qualifications

• QA professional experienced in GMP documentation, PPQ, SOP management, Cleaning Validation, and QMS activities including Change Controls, Deviations, CAPAs, customer complaints, and regulatory compliance.
• Review of executed BMR, ECR and Analytical Data.
• Review of BMR, ECR and SOP in Ensur Software.
• Preparation of Process Performance Qualification protocol & Monitoring of Process Performance Qualification activities.
• Preparation and Review of Annual Product Review.
• Preparation and review of SOPs.
• Handling Cleaning Validation.
• Handling Dispatch and line clearance activity.
• Handling of QMS related activities like Change Control, Event (Deviation/ Incident) and related CAPAs.
• Participate in handing of Customer Complaints, Return Goods and product recall.
• Evaluation of various QMS related activities like Change Control, Event (Deviation/ Incident).
• Any other work assigned by HOD.

Responsibilities

• Review of executed BMR, ECR and Analytical Data.
• Review of BMR, ECR and SOP in Ensur Software.
• Preparation of Process Performance Qualification protocol & Monitoring of Process Performance Qualification activities.
• Preparation and Review of Annual Product Review.
• Preparation and review of SOPs.

Skills

GMP documentation

PPQ

SOP management

Cleaning Validation

QMS activities

Change Controls

Deviations

CAPAs

Customer complaints

Regulatory compliance

Ensur Software

Tools

Ensur Software

Job description

Senior Executive-QA

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

QA professional experienced in GMP documentation, PPQ, SOP management, Cleaning Validation, and QMS activities including Change Controls, Deviations, CAPAs, customer complaints, and regulatory compliance. Review of executed BMR, ECR and Analytical Data. Review of BMR, ECR and SOP in Ensur Software. Preparation of Process Performance Qualification protocol & Monitoring of Process Performance Qualification activities. Preparation and Review of Annual Product Review. Preparation and review of SOPs. Handling Cleaning Validation. Handling Dispatch and line clearance activity. Handling of QMS related activities like Change Control, Event (Deviation/ Incident) and related CAPAs. Participate in handing of Customer Complaints, Return Goods and product recall. Evaluation of various QMS related activities like Change Control, Event (Deviation/ Incident). 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.