QA and Documentation Executive
5 days ago
**Company Description**
At Vroutes HR, we focus on creating coaction capabilities and empowering employers with the most precious asset-people. With a combination of innovative technology and personal touch, we have enabled marketing and advertising firms to achieve their vision. Founded in the year 2017 Vroutes HR have been striving hard to help agencies across India structure their human resources and achieve their short and long-term goals. We are lean and agile in adapting to the dynamic changes in modernized methods of HR functioning. From Staffing and Recruitment, Performance management, Training and Development, Employee Engagement, Compliance management, Payroll management, Grievances Handling, HR Strategy services and HR Audits we are a one stop solution for complete HR Solutions.
**Key Responsibilities**:
**FAT Coordination & Performance Testing**
- Oversee **Factory Acceptance Tests (FAT)** and ensure that systems meet quality and performance standards.
- Conduct **Performance Testing** and validation checks before dispatch.
**Documentation & Regulatory Compliance**
- Develop, review, and maintain **QA documentation, DQ documents, and process check records**.
- Ensure compliance with **GMP, ISO, and regulatory guidelines**.
- Manage **IQA (Internal Quality Audits)** and drive improvements based on audit findings.
**Customer & Cross-Functional Coordination**
- Act as the primary **point of contact for customer coordination** regarding quality-related queries.
- Work closely with the **procurement, finance, and production teams** to align quality processes.
**Quality Control & Risk Management**
- Conduct **Inward Quality Checks** on raw materials and finished products.
- Implement **risk management strategies** to prevent quality deviations.
- Ensure strict adherence to **quality management systems (QMS)**.
**Product & Process Knowledge**
- Maintain a deep understanding of **lyophilization systems, product functionality, and manufacturing processes**.
- Train teams on **quality standards, risk management, and regulatory requirements**.
**Team Management & Communication**
- Lead and mentor team members on **QA best practices**.
- Foster effective communication across departments for seamless execution of quality procedures.
**Key Requirements**:
✔ **Bachelor’s/Master’s degree** in **Pharmaceuticals, Biotechnology, Microbiology, Chemistry, or related fields**.
✔ **2+ years of experience** in Quality Assurance, preferably in **lyophilization, pharmaceutical, or biotech industries**.
✔ Strong knowledge of **FAT, DQ documentation, GMP, ISO, and risk management**.
✔ Experience in **process checks, internal audits, and customer coordination**.
✔ Proficiency in **MS Office, QMS software, and ERP systems**.
✔ Excellent communication, problem-solving, and team management skills.
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