QMS Lead - Biosimilar

Role & responsibilities

Quality Management system

• Review / approve Master documents like Batch documents, Specifications, Standard Test Procedures, artworks, Methods and other Good Manufacturing Practices (GMP) / quality related documents.
• Review/approve Site Master File (SMF), Validation Master Plan (VMP), Quality Manual and other organizational Quality Management System (QMS) related documents.
• Authorize to approve GMP/QMS documents, policies & protocols. Ensure that documents are prepared & implemented that meet GMP requirements.
• Approve/Reject Change Control, Deviation, CAPA and follow up for the closer of the same.
• Review / approve investigations, CAPA proposal & risk assessment.
• Attend / present status in Quality Review Meetings.
• Monitor internal audit program and ensure closure of audit findings.

• Audit and compliance:

• Compliance with the external and internal audit observations.
• Site preparedness / readiness for customer and regulatory audits.
• Responsible for overall QA compliance activity.

• Vendor qualification and management:

• Perform vendor audit (raw material / contract testing laboratory / calibration, GMP services & validation agency).
• Review / Approve vendor audit reports, qualification documents and related activities.
• Ensure adherence to audit schedule and closure of audit observation.
• Coordination with the vendors.

• Training and Development:

• Imparting the training to cross functional teams like Engineering, production and other departments on the relevant topics.
• Review / Approve training activities; and imparting inhouse training.
• Identify training needs and impart training at site.

• Analytical data assurance:

• Ensure laboratory activities are performed as per respective SOP.
• Ensure sample are timely testing & released, material / product is stored appropriately.
• Ensure investigation is performed for all the nonconformance / events.

• Documents Control:

• Ensure controlled copy, uncontrolled copy and other copy as per the requirement and issue to the concern department / personnel.
• Ensure the soft copy of the document in the QA folder.
• Ensure procedures related to Control of SOPs and Quality Documents are followed.