Contact: 8450934648
Salary: 1200000, No bar for suitable candidate, salary is depend upon the work experience, current CTC and interview process
- *Job Opening: Unit Manager – Quality Assurance (QA)**
- *Position: Unit Manager – Quality Assurance (QA)**
- *Location:** India
- *Department:** Quality Affairs
- *Reporting To:** Head – Quality Affairs India
We are looking for an experienced and detail\-oriented **Unit Manager – Quality Assurance (QA)** to ensure that product batches meet organizational quality requirements and support QA in the verification and release of products. The role will be responsible for maintaining and strengthening the organization's Quality Management System in compliance with **ISO 9001, ISO 14001, and EU GDP quality requirements**.
As a member of the Quality Affairs Department, the candidate will contribute to the continuous improvement and development of quality policies, standards, and management systems.
- *1\. Quality Control Activities**
- Ensure timely preparation of methods of analysis, analytical protocols, and method verification protocols.
- Review and approve method verification reports conducted at contract laboratories.
- Provide timely feedback on analytical queries and Out of Specification (OOS) investigations.
- Manage contracts with inspection agencies and contract laboratories.
- Actively participate in Quality Risk Management (QRM) activities with inspection agencies and laboratories.
- *2\. Support Large Programs**
- Collaborate and support QA teams to continuously improve coordination and business performance.
- Monitor and ensure KPIs for deviations and complaints remain within target trends.
- Contribute to process improvements for PPM vector control programs.
- *3\. Verification Audits**
- Conduct verification and data integrity audits to monitor the quality of batches supplied to the organization.
- Verify the correctness of product approval data supplied to the organization.
- Perform verification audits of contract laboratories.
- *4\. Quality Management \& Process Improvement**
- Contribute to the improvement of business processes.
- Support the development of policies and standards for the Quality Affairs Department.
- *5\. Monitoring \& Reporting**
- Prepare technical reports for PPM programs.
- Provide inputs for Annual QA Reports.
- Prepare client\-specific reports as required.
- *6\. Support Sales \& Commercial Operations**
- Manage QC services for large programs, including reporting activities.
- Manage external laboratory invoices for large programs.
- *7\. Training \& Development**
- Conduct interdepartmental and intradepartmental training on QA systems and organizational policies as required.
- *8\. Quality Management System (QMS)**
- Ensure the availability and maintenance of relevant documents in M\-Files.
- Conduct internal audits according to approved plans.
- *9\. Complaints \& Deviations Management**
- Ensure proper and timely handling of quality complaints related to LLINs and IRS.
- Ensure accurate and timely handling of deviations identified during inspections and product release activities.
- *Professional Knowledge**
- Demonstrates strong knowledge related to the position.
- Keeps updated with industry developments and organizational activities.
- Shares knowledge effectively within the organization.
- Understands, anticipates, and addresses customer needs.
- Maintains high service standards and customer satisfaction.
- Takes responsibility for assigned tasks and outcomes.
- Delivers work at a high standard to achieve business objectives.
- Proactively identifies and resolves issues.
- *Cooperation \& Teamwork**
- Works effectively with internal and external stakeholders.
- Builds and maintains mutually beneficial partnerships.
- Leverages information and collaboration to achieve results.
- Identifies opportunities for improvement.
- Takes proactive action to drive positive change and business excellence.
- *Qualifications \& Experience**
- Bachelor's Degree in a Science\-related field.
- Relevant experience in the Pharmaceutical Industry.
- Experience in Quality Assurance, Quality Control, Laboratory Management, or related functions preferred.
- In\-depth knowledge of testing and analytical processes.
- Strong understanding of Quality Management Systems.
- Knowledge of ISO 9001, ISO 14001, EU GDP requirements, and Data Integrity principles.
- Experience with audits, deviations, complaints management, and laboratory operations.
- Excellent English communication skills (written and verbal).
- Strong analytical, organizational, and problem\-solving abilities.
- Opportunity to work in a highly regulated pharmaceutical quality environment.
- Exposure to international quality standards and compliance systems.
- Collaborative and growth\-oriented Quality Affairs team.
- Opportunity to contribute to continuous improvement and operational excellence.
- *Apply Now and become a key contributor to maintaining the highest quality standards across our organization.**
Pay: From ₹1,200,000\.00 per year
Benefits
- Health insurance
- Internet reimbursement
- Leave encashment
- Paid sick time
- Paid time off
- Provident Fund
Work Location: In person