QA Executive
17 hours ago
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**Job Description: QA Executive (Pharmaceutical Manufacturing)**
**Position Title**: QA Executive
**Department**: Quality Assurance
**Location**: [Insert Location]
**Reports To**: Quality Assurance Manager
**Position Summary**:
The QA Executive is responsible for ensuring that pharmaceutical products meet the required quality standards and regulatory compliance throughout the manufacturing process. This role involves performing quality checks, audits, reviewing documents, and ensuring compliance with Good Manufacturing Practices (GMP) and other regulatory requirements to maintain high standards of product quality and safety.
**Key Responsibilities**:
- **Quality Assurance Activities**:
- Conduct regular inspections and quality checks on raw materials, in-process materials, and finished products.
- Ensure that manufacturing processes adhere to established SOPs (Standard Operating Procedures) and GMP regulations.
- Review batch records and related documents for accuracy and completeness.
- **Documentation and Compliance**:
- Ensure that all production documentation is properly maintained, reviewed, and compliant with regulatory requirements.
- Participate in the preparation, review, and approval of batch manufacturing records, release documents, and other regulatory documentation.
- Assist in preparing for regulatory audits and inspections, ensuring readiness and compliance.
- **Non-Conformance and CAPA**:
- Monitor and investigate non-conformances and deviations in manufacturing processes.
- Participate in the root cause analysis of quality issues and implement corrective and preventive actions (CAPA) as necessary.
- **Training and Support**:
- Provide training to production staff on quality standards, GMP, and company-specific procedures.
- Assist in conducting internal audits and provide guidance for continuous improvement initiatives.
- **Product Release**:
- Oversee and approve the release of finished products, ensuring that all necessary testing and quality checks are completed.
- Maintain records for product release and coordinate with production and regulatory teams to ensure timely and compliant product delivery.
- **Quality Systems Management**:
- Implement and monitor Quality Management System (QMS) policies and procedures.
- Assist in ensuring that all quality control systems are followed and maintained, with accurate and timely reporting.
- **Regulatory Compliance**:
- Stay updated on industry standards and regulatory requirements (e.g., FDA, WHO, ISO).
- Ensure compliance with all regulatory guidelines and assist with the preparation of required documentation for regulatory bodies.
**Qualifications**:
- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or a related field.
- Prior experience in Quality Assurance in a pharmaceutical manufacturing environment **(2 to 5 Years).**:
- Strong knowledge of GMP, FDA regulations, and other relevant quality standards.
- Excellent attention to detail and ability to maintain accurate records.
- Strong communication and problem-solving skills.
- Ability to work independently as well as part of a team.
**Skills and Competencies**:
- Analytical thinking and decision-making ability.
- Proficiency in MS Office and relevant quality management software.
- Familiarity with quality auditing techniques and regulatory inspections.
- Strong understanding of pharmaceutical manufacturing processes.
**Job Types**: Full-time, Permanent
Pay: ₹15,000.00 - ₹30,000.00 per month
**Benefits**:
- Cell phone reimbursement
- Health insurance
- Internet reimbursement
- Leave encashment
- Life insurance
- Paid sick time
- Provident Fund
Schedule:
- Day shift
- Morning shift
Supplemental Pay:
- Performance bonus
- Yearly bonus
**Education**:
- Bachelor's (required)
**Experience**:
- QA, Pharma Industry: 2 years (required)
Work Location: In person
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