Quality Assurance Executive

**Key Responsibilities**:
**Quality Assurance Monitoring and Auditing**:

- Conduct regular audits of manufacturing processes, materials, and finished products to ensure compliance with quality standards and regulatory requirements (e.g., GMP, ISO).
- Perform internal audits of systems, processes, and documentation to ensure they align with company policies and industry best practices.
- Ensure adherence to quality standards by reviewing and approving batch records, manufacturing instructions, and quality control documentation.

**Process Improvement and Compliance**:

- Identify opportunities for process improvements and work with cross-functional teams to implement corrective and preventive actions (CAPAs).
- Monitor and evaluate the effectiveness of CAPAs and assist in resolving quality-related issues.
- Develop, update, and ensure compliance with standard operating procedures (SOPs) related to quality assurance and product quality.

**Product and Supplier Qualification**:

- Conduct supplier evaluations and audits to ensure suppliers meet required quality standards and regulatory guidelines.
- Assist in the qualification and validation of new materials, components, and suppliers.
- Ensure that all incoming raw materials and components meet quality specifications before they are used in production.

**Regulatory Compliance**:

- Ensure compliance with all regulatory requirements and industry standards (e.g., FDA, EMA, ISO, and local regulations).
- Assist in the preparation of regulatory submissions and documentation for product registrations and audits.
- Monitor regulatory changes and update internal quality systems to stay compliant with new laws and guidelines.

**Documentation and Reporting**:

- Prepare and maintain detailed quality assurance reports, audit reports, inspection findings, and compliance records.
- Maintain accurate documentation of quality assurance activities, ensuring data integrity and accessibility.
- Provide regular updates and reports to management on the status of quality-related initiatives and key performance indicators (KPIs).

**Training and Development**:

- Provide training and support to production and other departments on quality standards, regulatory requirements, and best practices.
- Stay up-to-date with the latest developments in quality assurance methodologies, industry regulations, and technological advancements.
- Promote a culture of quality across the organization by emphasizing the importance of quality at all stages of production and product development.

**Risk Management**:

- Conduct risk assessments and analyses to identify potential risks in manufacturing processes and product quality.
- Collaborate with the production team to implement risk mitigation strategies and ensure that quality is not compromised at any stage of production.

**Skills and Qualifications**:

- Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field.
- [Insert Number] years of experience in quality assurance, preferably in [Insert Industry Type, e.g., Pharmaceuticals, FMCG, Medical Devices].
- Strong knowledge of quality management systems (QMS), ISO 9001, GMP, and relevant industry-specific regulations (e.g., FDA, EMA).
- Proven experience in conducting audits, managing CAPA processes, and handling regulatory compliance.
- Excellent problem-solving skills and the ability to make data-driven decisions.
- Strong attention to detail and organizational skills to manage multiple tasks and priorities effectively.
- Good understanding of statistical process control (SPC), risk management techniques, and validation protocols.
- Strong communication and interpersonal skills to work effectively with cross-functional teams and external stakeholders.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint), as well as familiarity with quality management software and systems.

Pay: ₹18,000.00 - ₹22,000.00 per month

**Benefits**:

- Cell phone reimbursement

Schedule:

- Day shift

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

Application Deadline: 23/11/2024
Expected Start Date: 23/11/2024