Quality Assurance Head(Auranagabd)
Job Description:
Position Overview: The Quality Assurance (QA) Head in the pharmaceutical industry plays a crucial role in ensuring that all aspects of the company's operations comply with regulatory requirements and quality standards. This leadership position involves overseeing the development, implementation, and maintenance of a robust quality management system to guarantee the safety, efficacy, and quality of pharmaceutical products.
Key Responsibilities:
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Quality Management System (QMS) Leadership:
- Develop, implement, and maintain an effective QMS in compliance with applicable regulations (e.g., FDA, EMA) and industry standards.
- Ensure that all quality processes and procedures are documented, up-to-date, and communicated to relevant stakeholders.
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Regulatory Compliance:
- Stay abreast of regulatory changes and updates to ensure continuous compliance with national and international regulatory requirements.
- Collaborate with regulatory affairs to prepare for and manage regulatory inspections.
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Quality Oversight:
- Provide leadership and guidance to the QA team to conduct internal and external audits to assess compliance with quality standards.
- Monitor and evaluate the performance of quality control activities, including in-process checks and final product release.
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Risk Management:
- Implement risk management strategies to identify and mitigate potential risks to product quality and patient safety.
- Establish and maintain a system for handling deviations, investigations, and corrective and preventive actions (CAPA).
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Documentation and Recordkeeping:
- Ensure the accuracy and completeness of all quality-related documentation and records.
- Implement document control processes to manage the creation, review, approval, and distribution of documents.
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Training and Development:
- Provide training programs to ensure that all personnel understand and adhere to quality standards and regulatory requirements.
- Foster a culture of quality and continuous improvement through ongoing education and training initiatives.
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Supplier and Vendor Management:
- Develop and maintain strong relationships with suppliers and vendors, ensuring their compliance with quality standards.
- Conduct supplier audits and assessments to evaluate their capability to meet quality requirements.
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Quality Metrics and Reporting:
- Establish key performance indicators (KPIs) for quality and regularly report on the performance of the quality management system to senior management.
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Continuous Improvement:
- Drive continuous improvement initiatives based on data analysis, audits, and feedback from internal and external stakeholders.
- Implement best practices and innovative solutions to enhance overall product quality and operational efficiency.
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Communication and Collaboration:
- Collaborate with cross-functional teams, including research and development, production, and regulatory affairs, to ensure alignment on quality objectives.
- Communicate effectively with regulatory agencies, customers, and other external stakeholders regarding quality-related matters.
Qualifications:
- Bachelor's or advanced degree in a relevant scientific or engineering field.
- Extensive experience in quality assurance roles within the pharmaceutical industry.
- Thorough knowledge of regulatory requirements and quality standards (e.g., cGMP, ICH).
- Strong leadership and communication skills.
- Experience in managing regulatory inspections and interacting with regulatory agencies.
- Analytical and problem-solving skills with a focus on continuous improvement.
Key Skills :
Company Profile
These activities are supported with a strong infrastructure such as 5 manufacturing plants, 21 branch offices – cum – distribution centers, more than 300 strong marketing force throughout the country meeting 50,000 doctors every month supported by a network of around 1000 stockiest–cum–distributors. The company is putting a lot of thrust towards R & D efforts and has successfully launched few technologies, the first time in the country through its own government approved R&D centers. --- Group of Companies also have received three Export awards from the government and over a dozen awards from various organizations in recognition of its achievements.
Apply Now
- Interested candidates are requested to apply for this job.
- Recruiters will evaluate your candidature and will get in touch with you.