Quality Assurance Specialist | Drive Compliance & Continuous Improvement | Goa
Quality Assurance Specialist
Division: Quality
Department: Quality
Employment Type: Permanent
Job Purpose
The Quality Assurance Specialist is responsible for ensuring that the unit adheres to the Quality Management System (QMS) and meets regulatory expectations. The role involves driving continuous improvements in current Good Manufacturing Practices (cGMP) to ensure compliance and enhance operational efficiency.
Key Accountabilities
1. Investigations & CAPA Implementation
- Establish a systematic approach for investigating non-conformances within the QMS.
- Determine root causes and implement Corrective and Preventive Actions (CAPA) in line with cGMP requirements.
2. QMS Documentation Management
- Design a comprehensive plan for compiling, reviewing, and timely closure of QMS documents.
- Ensure that documentation meets compliance standards with relevant quality systems.
3. QMS Document Control
- Analyze QMS documents for completeness and accuracy in alignment with cGMP requirements.
- Maintain control systems to ensure the integrity of all QMS documentation.
4. Continuous Improvement in QMS
- Identify and implement continual improvements in QMS by reviewing regulatory updates.
- Simplify Standard Operating Procedures (SOPs) and procedures to ensure adherence to cGMP standards.
5. Regulatory Compliance & Audit Management
- Plan and oversee the resolution of audit observations to ensure regulatory compliance.
- Monitor and supervise compliance activities until full closure of any issues.
6. Communication & Feedback
- Direct and supervise communication channels to provide feedback on QMS-related queries.
- Address deficiencies as per standard procedures and technical agreements.
7. Team Development & Leadership
- Develop and mentor team members to enhance their performance and contribution to team goals.
- Lead with empathy and foster a collaborative environment to achieve success.
Educational Qualifications
- B. Pharm. / M. Pharm. / M. Sc.
Relevant Work Experience
- 8-12 years for B. Pharm.
- 6-8 years for M. Pharm. / M. Sc.
Competencies & Skills
| Competency | Description |
|---|---|
| Collaborate to Succeed | Work effectively with others to achieve shared goals. |
| Innovate to Excel | Seek innovative solutions to improve processes and performance. |
| Perform with Accountability | Take responsibility for actions and results. |
| Lead with Empathy | Demonstrate understanding and consideration for others’ perspectives. |
| Act with Agility | Adapt quickly to changes and new challenges. |
| Strong Domain Knowledge | Deep understanding of quality management and cGMP. |
| People Management | Ability to mentor, guide, and develop team members. |
Job Location
- Goa
The role of a Quality Assurance Specialist is crucial in maintaining the integrity of the Quality Management System and ensuring compliance with regulatory standards. This position not only requires a strong understanding of cGMP and quality management but also effective leadership and communication skills to drive continuous improvement and foster a collaborative work environment.
For more information on Quality Management Systems, you may refer to the Wikipedia article on Quality Management.
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