QA Executive

2 days ago

Bavla Ahmedabad Gujarat, India Zenon Full time

Quality Management System (QMS) Development and Maintenance:

- Develop, implement, and maintain a robust quality management system (QMS) in accordance with regulatory requirements such as FDA, EMA, and other applicable standards.
- Establish and maintain quality assurance procedures, policies, and documentation, including SOPs (Standard Operating Procedures), work instructions, and quality records.

Regulatory Compliance:

- Ensure compliance with all relevant regulatory requirements, guidelines, and standards governing pharmaceutical manufacturing, distribution, and quality assurance.
- Stay current with changes in regulations and industry best practices, implementing necessary updates to maintain compliance.

Audits and Inspections:

- Plan, coordinate, and conduct internal audits to assess compliance with quality standards, procedures, and regulations.
- Prepare for and participate in external audits and regulatory inspections, addressing findings and implementing corrective actions as necessary.

Quality Control
- Oversee quality control activities, including raw material testing, in-process testing, and finished product testing, to ensure compliance with specifications and standards.
- Monitor and analyze quality metrics and trends, identifying areas for improvement and implementing corrective and preventive actions (CAPAs).

Documentation and Record Keeping:

- Manage the documentation and record-keeping processes related to quality assurance activities, ensuring accuracy, completeness, and traceability of records.
- Maintain a document control system to manage revisions, approvals, and distribution of quality documents.

Training and Development:

- Provide training and guidance to employees on quality assurance procedures, regulations, and best practices.
- Foster a culture of quality and continuous improvement by promoting awareness and understanding of quality principles throughout the organization.

Supplier and Vendor Management:

- Establish and maintain quality agreements with suppliers and vendors, ensuring that materials and services meet quality requirements.
- Conduct supplier audits and assessments to evaluate compliance and performance, addressing any non-conformities identified.

Continuous Improvement:

- Lead and support quality improvement initiatives and projects to enhance processes, products, and systems.
- Utilize quality tools and techniques such as root cause analysis, statistical process control, and risk management to drive continuous improvement.

Pay: ₹20,000.00 - ₹40,000.00 per month

**Benefits**:

- Leave encashment
- Provident Fund

**Education**:

- Bachelor's (preferred)

**Experience**:

- OSD Formulation: 2 years (preferred)

**Language**:

- GUJARATI,HINDI,ENGLISH (preferred)

Shift availability:

- Day Shift (preferred)

Work Location: In person

**Speak with the employer**
+91 8799622131

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