Trainee, Quality Assurance

About 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. They serve clients through a globally integrated network of facilities in North America, Europe, and Asia. Their services include Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms, and specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Job Title: Trainee - Quality Assurance

Job Overview

As a Quality Assurance Trainee, you will support Quality Assurance activities related to document control, SOP management, qualification and validation support, and compliance monitoring in line with GMP and regulatory requirements.

Key Responsibilities

• Issuance, archival, and tracking of QA documents
• Issuance of Control copies to respective departments
• Maintaining backups of QA softcopies
• Maintaining SOPs with proper indexing
• Preparation and review of SOPs
• Performing Qualifications for new/existing equipment
• Ensuring and coordinating Area Validations
• Reviewing Calibration/PM Schedules
• Preparation of VMP and Validation documents
• Handling Vendor Qualifications activities
• Handling Contract testing laboratory
• Handling External Service Provider
• Supporting QMS related activities including:
• Deviations
• Change Controls
• OOS
• OOT
• CAPA
• Compliants
• Return goods
• Risk assessment
• Product recall

Key Stakeholders

• Internal: Production (Synthesis + Pharma) Team, Quality Assurance Team, Quality Control Team, Engineering Department
• External: Auditors, Suppliers, Customers

Reporting Structure

Reporting to the Quality Assurance Manager

Requirements & Tech Stack

• Skills and Competencies:
• Basic understanding of GMP, documentation, and quality systems
• Strong attention to detail and compliance orientation
• Good coordination and communication skills
• Ability to manage and organize QA documents and records
• Willingness to learn and adapt in a regulated pharmaceutical environment

Qualifications

• M.Sc. / B.Sc.