
Pharmaceutical Quality Assurance Leader
17 hours ago
We are seeking an experienced and skilled pharmaceutical quality assurance leader to lead our manufacturing plant in Chandigarh, India.
The ideal candidate should possess a degree in pharmacy or a related field (B.Pharm / M.Pharm / M.Sc.) and have at least 12-15 years of experience in the pharmaceutical industry and similar roles.
Key Responsibilities:- Compliance and Regulatory Oversight: Ensure adherence to regulatory requirements and industry standards, such as ISO 9001 and WHO-GMP guidelines.
- Quality Management System (QMS): Develop and implement effective QMS strategies to ensure product quality and customer satisfaction.
- Product Lifecycle Management: Oversee the entire product lifecycle, from development to launch and post-market surveillance.
- Leadership and Team Management: Lead cross-functional teams and foster a culture of collaboration and innovation.
- Risk and Incident Management: Identify and mitigate risks, and manage incidents effectively.
- Documentation and Record-Keeping: Maintain accurate and complete records, and ensure compliance with regulatory requirements.
- Process and Cleaning Validation: Develop and implement validation protocols for processes and cleaning procedures.
- Vendor and Raw Material Quality: Ensure the quality of vendors and raw materials, and maintain relationships with suppliers.
- Cross-Functional Coordination: Collaborate with various departments to ensure seamless integration and effective communication.
- Audits and Compliances: Plan and conduct audits, and ensure compliance with regulatory requirements.
The role requires experience working with ISO standards and WHO-GMP guidelines. Knowledge of the local market and ability to coordinate with vendors and stakeholders is essential.
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