Recruiter at PersolKelly
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Head - Quality Assurance - Biologics/BioPharma (20-27 yrs)
Head Quality Assurance - Biologics/BioPharma
We have a job opportunity for "Head- Quality Assurance" for Biologics/Biopharma with Leading Pharma company in Pune.
- 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.
- 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.
- 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