Head Quality Assurance - Biologics/BioPharma

We have a job opportunity for "Head- Quality Assurance" for Biologics/Biopharma with Leading Pharma company in Pune.

Regulatory Compliance:

- Ensure compliance with all relevant regulatory requirements, including national and international guidelines such as those issued by FDA, EMA, and other regulatory bodies.

- Interpret and apply quality standards, guidelines, and regulations to ensure products and processes meet required standards.

Quality Systems Management:

- Develop, implement, and maintain robust quality management systems (QMS) to ensure consistent adherence to quality standards throughout the organization.

- Monitor and continuously improve quality processes, standard operating procedures (SOPs), and work instructions.

Audits and Inspections:

- Plan and execute internal and external audits to assess compliance with quality systems and regulatory requirements.

- Coordinate and prepare the organization for regulatory inspections, responding to findings and implementing corrective actions as needed.

Documentation and Records Management:

- Oversee the maintenance of accurate and up-to-date documentation related to quality systems, including batch records, validation protocols, and other quality documents.

- Ensure proper records management practices, including document control and archiving.

Quality Review and Release:

- Review and approve batch records, testing data, and other documentation to ensure products meet quality specifications before release.

- Collaborate with cross-functional teams to address any quality-related issues that may arise during manufacturing.

Training and Development:

- Provide training and guidance to employees regarding quality standards, regulations, and best practices.

- Foster a culture of quality awareness and continuous improvement throughout the organization.

Risk Management:

- Identify potential quality risks and develop strategies to mitigate them.

- Implement risk management processes to proactively address quality issues and prevent their recurrence.

Vendor and Supplier Management:

- Ensure that suppliers and vendors meet quality and regulatory requirements through audits and assessments.

- Collaborate with procurement teams to evaluate and select suppliers based on quality criteria.

Continuous Improvement:

- Lead quality improvement initiatives and projects to enhance overall product quality, efficiency, and compliance.

- Implement tools and methodologies to monitor and measure quality performance metrics.

Qualifications and Skills:

- Bachelor's or Master's degree in a relevant scientific discipline (e.g., Pharmacy, Chemistry, Biology, Biotechnology).

- Extensive experience in quality assurance within the biopharmaceutical industry.

- In-depth knowledge of regulatory guidelines and standards related to pharmaceutical and biopharmaceutical products.

- Strong leadership and communication skills to manage cross-functional teams and interact with regulatory agencies.

- Problem-solving and analytical abilities to identify and address quality-related issues effectively.

- Attention to detail and a commitment to maintaining high-quality standards.

- Proven track record of successfully managing regulatory inspections and audits