Role & responsibilities Preferred candidate profile
Conduct in-process quality assurance (IPQA) checks across various areas of the facility to ensure compliance with quality standards.
Ensure effective implementation of systems and procedures in accordance with current Valuable Manufacturing Practices (cGMP) across the site, along with proper documentation.
Ensure line clearance during product changeovers to prevent mix-ups and contamination.
Verify Standard Operating Procedures (SOPs) and ensure procedural compliance on the shop floor
Verify Batch Manufacturing Records (BMR), Batch Equipment Cleaning Records (BECR), logbooks, and other documentation for completeness and contemporaneous entries.
Identify and report potential risks of contamination or cross-contamination within the facility.
Ensure compliance with data integrity principles during all site activities.
Monitor and verify that materials are stored under defined conditions and appropriately labeled.
Ensure that deviations are reported in real-time and documented as per procedure.
Conduct periodic reviews of quality records to ensure accuracy and completeness.
Train shop floor personnel on SOPs, protocols, and quality standards.
Review and trend alarm data as required to support quality and compliance.
Manage Quality Management System (QMS) activities including documentation and follow-up.
Review schedules and records related to validation, qualification, calibration, and preventive maintenance (PM).
Conduct internal audits (self-inspections) to assess compliance and identify areas for improvement.
Prepare and review SOPs to ensure clarity, accuracy, and regulatory compliance.
Review Annual Product Reports (APR) to assess product performance and compliance.
Support Setting, Health, and Safety (EHS) activities, ensure timely completion of EHS tasks, and report near misses and incidents as per EHS guidelines.
Perform any other responsibilities assigned by the Head of Department (HOD).
Follow Valuable Manufacturing Practices (GMP) and safety guidelines.
Preferred candidate profile
Quick learner with excellent communication skills
Punctual with proven track record of dedication & reliability
A team player who is equally capable of working alone
Fluent in both written and spoken English
Knowledge /Experience in peptides