Production - Sterile - Trainee

PeopleStrong; Daman; On-site; INR 300,000 - 500,000; Full time

Job summary

PeopleStrong in Daman is seeking a Quality Management intern to assist in documenting, tracking, and managing quality-related tasks. You will work closely with senior officers to ensure compliance with cGMP guidelines and help maintain audit readiness.

This role provides an excellent opportunity to learn about Quality Management Systems, SOPs, and various compliance regulations while supporting the overall smooth functioning of a sterile manufacturing environment.

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Qualifications

• Understanding of cGMP guidelines and sterile manufacturing regulations.
• Basic knowledge of Quality Management Systems (QMS).

Responsibilities

• Document shop-floor incidents and deviations in the sterile area.
• Track the implementation of Corrective and Preventive Actions (CAPA).
• Assist in managing Quality Management System (QMS) documents.
• Draft and format Standard Operating Procedures (SOPs).
• Gather batch records for technical review.

Job description

Deviation Logging: Learn and assist in the initial documentation, registration, and tracking of shop-floor incidents and deviations in the sterile area.

CAPA Follow-Up: Support senior officers in tracking the implementation timelines and closure status of Corrective and Preventive Actions (CAPA).

Document Management: Assist in the systematic tracking, printing, routing, and archiving of Quality Management System (QMS) documents, including Change Controls and logbooks.

SOP Coordination: Learn to draft and format revisions for Standard Operating Procedures (SOPs) and manufacturing checklists under direct technical supervision.

BMR/BPR Review Support: Assist in gathering batch records and data sheets for technical review, learning to identify data integrity gaps according to ALCOA+ principles.

EM Trend Tracking: Help compile, enter, and track Environmental Monitoring (EM) data, particle counts, and differential pressure logs for Grade A/B/C/D cleanrooms.

Audit Preparation: Maintain neat, organized department files and document archives to support continuous audit readiness (USFDA/MHRA).

Compliance Learning: Attend training on cGMP guidelines, sterile manufacturing regulations (such as EU Annex 1), and basic Quality Risk Management (QRM) tools.