Executive - QA

**The**Opportunity**:
The QA Specialist in IND plays a crucial role in overseeing the quality assurance processes across the company’s three manufacturing sites (Mumbai, Panoli, and Dehradun). The core responsibility of this position is managing and resolving non
- product quality issues, ensuring adherence to quality control procedures, and maintaining product excellence by collaborating with various teams, the specialist acts as the primary contact for resolving non-conformance issues and minimizing the recurrence of quality problems. QA Specialist is a vital role that ensures high standards of product quality, operational excellence, and regulatory compliance across the company’s manufacturing operations.

**What we’re looking for**:

- ** Education**:B.Sc/M.Sc (Chemistry, Biology, Microbiology)
- ** Experience**:Minimum 5-8 years of experience

**How you will thrive and create an impact**:
**1. Non-Product Quality Issue Management**:

- Identify, document, and resolve non-product related quality issues across the Mumbai, Panoli, and Dehradun manufacturing sites.
- Ensure compliance with established quality control procedures, work instructions, and GMP standards.
- Monitor and address non-conformance issues to prevent recurrence, coordinating with relevant teams and departments.

**2**. **Site Coordination & Communication**:

- Serve as a liaison between the three manufacturing sites, ensuring smooth communication and effective resolution of non-product quality issues.
- Collaborate with site managers, production teams, and quality specialists to ensure consistent quality control practices across all sites.

**3. Compliance with Regulatory Requirements**:

- Ensure actions taken to address non-product quality issues comply with internal policies and external regulatory requirements (e.g., GMP, ISO).
- Perform audits, review documentation (e.g., COA/COC), and ensure adherence to quality standards at all times.

**4.** **Root Cause Analysis and Corrective Actions**:

- Utilize problem-solving tools like 5M+E and 5 Why’s to identify root causes of non-product quality issues.
- Implement corrective actions across all three sites to ensure issues are effectively addressed and do not recur.

**5.** **Continuous Improvement**:

- Drive continuous improvement initiatives to optimize processes and reduce non-conformance issues.
- Collaborate with site-specific and regional teams to improve overall product quality and operational efficiency.

**6.** **Documentation and Reporting**:

- Oversee the documentation of non-product quality issues and track trends to ensure timely resolution.
- Prepare and maintain accurate and timely reports on quality control activities and issues identified across all sites.

**7**. **Customer Complaint Investigations**:

- Lead and manage all investigations related to customer complaints, ensuring thorough root cause analysis and timely resolution to improve customer satisfaction.

**8. Audit Oversight**:

- Oversee internal and external audits to ensure compliance with ISO 9001:2015, Medical Devices, GDP, and other relevant standards.
- Serve as the appointed Lead Auditor for relevant certifications, ensuring audits align with regulatory requirements.

**9. Quality Management Systems (QMS)**:

- Develop, implement, and maintain the QMS to ensure compliance with ISO regulatory standards.
- Drive the continuous improvement of the QMS by incorporating best practices, process enhancements, and risk mitigation strategies.

**10.** **Document Management**:

- Oversee the document control system to ensure all documentation is up-to-date, compliant, and easily accessible for review during audits.

**11.** **ETQ System Development and Training**:

- Lead the development and training of the ETQ system across the DC IND to ensure teams are proficient in system usage for quality management and compliance.

**12.**Quality Culture and Continuous Improvement**:

- Foster a culture of continuous improvement at the IND manufacturing site, guiding cross-functional teams to optimize quality performance.
- Spearhead quality improvement initiatives, encouraging a culture of excellence across all operations.

**13.** **Third-Party Logistics & Warehouse Audits**:

- Oversee audits of third-party logistics providers and extended warehouses, ensuring compliance with quality standards and regulatory requirements.

**14.** **Certification Management**:

- Lead and maintain certification audits to ensure compliance with ISO and industry-specific standards.
- Ensure the organization consistently meets regulatory demands.

**15.** **Essential Skills and Qualifications**:

- Extensive experience in quality assurance within regulated industries (ISO 9001:2015, Medical Devices, GDP).
- Strong knowledge of QMS, audit processes, and document control.
- Proven ability to lead and manage cross-functional teams in driving continuous improvement and compliance.
- Strong analytical skills, with experience in customer comp