Trainee - Quality Assurance

Piramal Pharma Limited; Thane; On-site; INR 200,000 - 320,000; Full time

Job summary

Piramal Pharma Solutions in Thane is seeking a Quality Assurance Trainee to support document control, SOP management, qualification and validation activities in line with GMP and regulatory requirements.

The role involves issuance, archival of QA documents, calibration reviews, vendor qualifications, deviations and change controls, and related QMS tasks under QA Manager supervision.

Qualifications

• GMP, documentation, and quality systems familiarity.
• 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.

Responsibilities

• Issuance, archival and retrieval of documents.
• Issuance of Control copies to respective dept.
• Tracking of all QA documents.
• Maintaining backup of QA softcopies.
• Maintaining SOPs with proper indexing.
• Preparation and review of SOPS.
• Perform Qualifications for new equipment's/existing equipment's.
• Ensure and Co-ordination of Area Validations.
• Reviewing of Calibration/PM Schedules.
• Preparation of VMP and Validation documents.
• Handling of Vendor Qualifications activities.
• Handling of Contract testing laboratory.
• Handling of External Service Provider.
• Handling of Deviations, Change Controls, OOS, OOT, CAPA, compliants, return goods, risk assessment and product recall (QMS related activities)

Skills

GMP knowledge

Documentation

Quality systems

Attention to detail

Coordination

Communication

QA documentation handling

Education

M.Sc./B.Sc.

Job description

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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

Job Title

Trainee - Quality Assurance

Job Description

Job 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 Manager

Qualification

M.Sc. / B.Sc.

Experience (No of Years)

Not Required

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

Responsibilities

• Issuance, archival and retrieval of documents
• Issuance of Control copies to respective dept.
• Tracking of all QA documents
• Maintaining of backup of QA softcopies.
• Maintaining SOPs with proper indexing
• Preparation and review of SOPS
• Perform Qualifications for new equipment's/existing equipment's.
• Ensure and Co-ordination of Area Validations
• Reviewing of Calibration/PM Schedules.
• Preparation of VMP and Validation documents
• Handling of Vendor Qualifications activities
• Handling of Contract testing laboratory
• Handling of External Service Provider.
• Handling of Deviations, Change Controls, OOS, OOT, CAPA, compliants, return goods, risk assessment and product recall (QMS related activities)