Trainee - Quality Assurance

Piramal Pharma Limited; Turbhe; Sur place; INR 201 000 - 335 000; Plein temps

Résumé du poste

Piramal Pharma Limited is seeking a Quality Assurance Trainee to support document control, SOP management, qualification and validation activities in line with GMP and regulatory requirements. You will issue, archive, and track QA documents, coordinate equipment qualification and area validations, and assist with vendor qualifications and deviations.

The role reports to the Quality Assurance Manager and requires M.Sc. or B.Sc.

Qualifications

• 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.

Responsabilités

• 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 or existing equipment.
• Ensure and Co-ordination of Area Validations.
• Reviewing 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, complaints, return goods, risk assessment and product recall (QMS related activities)

Connaissances

GMP knowledge

Documentation

Quality systems

Attention to detail

Coordination

Communication

QA document control

Regulated environment

Formation

M.Sc.

B.Sc.

Description du poste

About the Company

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 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.) 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 & 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)

About PPL

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.

Equal Employment Opportunity

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.