Director - Testing - Pharma

Role Purpose : The Director of Clinical Quality Assurance serves as a strategic quality resource in managing quality and regulatory compliance related to GCP, Pharmacovigilance (PV) and other related activities

Job Description :

- Develop and implement QA infrastructure capable of supporting the GCP and PV

- Oversight of all quality assurance initiatives including management of quality and regulatory compliance related to GCP and PV activities

- Coordinates the revision, review, and approval of SOPs and other GxP documents.

- Organizes and ensures accurate and reliable filing systems for the paper-based GxP documents.

- Selects, evaluates, and implements electronic document processing and archiving systems.

- Ensure all systems, processes and their outcomes comply with applicable regulations and guidelines

- Represent the organization during customer visits. Provide support for all audits and inspections by customers and regulatory agencies if any

- Oversee GCP activities (including internal or external audit observations and development of CAPA) to ensure data integrity

- BE/B.Tech/MCA from recognized institute with good academic score

- Quality professional with min 15 years of hands-on experience in QA in bio-pharmaceutical industry.

- In-depth Knowledge of GxP, QA best practices and regulatory guidelines

- Experienced in Documentation authoring and requirement analysis (min. 3 years

- 15 plus year of experience in Quality Management

- Sound knowledge of Project and Quality Management methodologies like SDLC, reviews, and training

- Excellent understanding of complex quality landscapes and relationships (Quality Systems, Policies, IT QM)

- Leading and managing Global team directly

Utpal