Quality Assurance

6 days ago

Gurugram Haryana, India Ethics Group Of Companies Full time

Quality Systems Management: Develop, implement, and maintain quality systems and processes to ensure compliance with regulatory requirements, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).
- Document Control: Manage document control processes, including document creation, review, approval, distribution, and archiving, to ensure accuracy, completeness, and compliance with regulatory standards
- **Batch Record Review: Review batch records, analytical data, and other documentation to ensure compliance with established procedures, specifications, and regulatory requirements.**
- Quality Audits: Conduct internal audits and supplier audits to assess compliance with quality standards and identify areas for improvement. Prepare audit reports and collaborate with stakeholders to implement corrective and preventive actions (CAPAs).
- Change Control: Evaluate proposed changes to processes, equipment, facilities, and documentation to assess potential impact on product quality and regulatory compliance. Manage change control processes to ensure appropriate review, approval, and implementation of changes.
- Deviation Management: Investigate and document deviations, out-of-specification (OOS) results, and non-conformances. Identify root causes and implement corrective and preventive actions to prevent recurrence.
- Training and Education: Provide training and guidance to employees on quality systems, procedures, and regulatory requirements to ensure understanding and compliance.
- Quality Risk Management: Identify and assess risks to product quality and patient safety. Develop and implement risk mitigation strategies to minimize potential impact.

**Qualifications**:

- Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field. Advanced degree (e.g., Master’s or PhD) preferred.
- Minimum of [X] years of experience in quality assurance within the pharmaceutical industry, with a comprehensive understanding of GMP, GLP, and GDP requirements.
- Strong knowledge of regulatory guidelines (e.g., FDA, EMA, ICH) and industry standards.
- Experience in conducting quality audits and managing CAPA processes.
- Excellent communication, interpersonal, and problem-solving skills.
- Ability to work effectively in a fast-paced environment and manage multiple priorities simultaneously
- **Detail-oriented with a commitment to accuracy and compliance**

Pay: ₹400,000.00 - ₹500,000.00 per year

Schedule:

- Morning shift

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

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