Trainee - Quality Assurance

Piramal Pharma; Navi Mumbai; On-site; INR 167,000 - 279,000; Full time

Job summary

Piramal Pharma Limited is seeking a Quality Assurance Trainee to support document control, SOP management, qualification and validation activities, and GMP/regulatory compliance monitoring.

The role includes issuance, archival, and tracking of QA documents, coordination of equipment qualification and area validations, review of calibration schedules, and involvement in vendor qualifications, deviations and change controls.

Qualifications

• Basic understanding of GMP, documentation, and quality systems.
• Strong attention to detail and compliance orientation.
• Good coordination and communication skills.
• Willingness to learn and adapt in a regulated pharmaceutical environment.

Responsibilities

• Issuance, archival and retrieval of QA documents and SOPs.
• Assist in qualification and validation activities, calibration review, and preventive maintenance tracking.
• Support vendor qualifications, external service providers, deviations, change controls, CAPA and QMS activities.
• Coordinate with Production, QA, QC, Engineering and suppliers as required.

Skills

GMP

Documentation

Quality systems

Coordination

Communication

Attention to detail

Regulatory compliance

Learning mindset

Education

M.Sc.

B.Sc.

Job description

Be the First to ApplyDivisionPiramal Pharma SolutionsPiramal 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.comJob TitleTrainee - Quality AssuranceJob DescriptionJob Overview : As a Quality Assurance Trainee, You will be responsible for supporting Quality Assurance activities related to document control, SOP management, qualification and validation support, and compliance monitoring in line with GMP and regulatory requirements. The role involves issuance, archival, and tracking of QA documents, coordination of equipment qualification and area validation activities, review of calibration and preventive maintenance schedules, preparation of validation-related documents, and support in handling vendor qualifications, external service providers, deviations, and change controls, and related processes.Internal Key Stakeholders : Production (Synthesis + Pharma) Team, Quality Assurance Team, Quality Control Team, Engineering Department, etc. (As per the requirement of the allocated task.)Internal Key Stakeholders : Auditors, Suppliers, Customers, etc. (As per the requirement of the allocated task.)Reporting Structure : Reporting to the Quality Assurance ManagerQualififcation : M.Sc. / B.Sc.Experience (No of Years): Not RequiredSkills AND Competencies :Basic understanding of GMP, documentation, and quality systemsStrong attention to detail and compliance orientationGood coordination and communication skillsAbility to manage and organize QA documents and recordsWillingness to learn and adapt in a regulated pharmaceutical environmentIssuance, archival and retrieval of documentsIssuance of Control copies to respective dept.Tracking of all QA documentsMaintaining of backup of QA softcopies.Maintaining SOPs with proper indexingPreparation and review of SOPSPerform Qualifications for new equipment's/existing equipment's.Ensure and Co-ordination of Area ValidationsReviewing of Calibration/PM Schedules.Preparation of VMP and Validation documentsHandling of Vendor Qualifications activitiesHandling of Contract testing laboratoryHandling of External Service Provider.Handling of Deviations, Change Controls, OOS, OOT, CAPA, compliants, return goods, risk assessment and product recall (QMS related activities)