Job Title: Quality Systems Specialist

Reports to: Vice President - Operations

- JOB Purpose

The Quality Systems Specialist oversees implementing quality management procedures, ensuring efficiency and smooth workflow. Main responsibilities include gathering and analyzing data to identify the strengths and weaknesses of current operations, developing new strategies to optimize quality procedures, creating new quality assurance methods, maintaining quality records, coordinating the quality operations, and implementing solutions, configure and validate Veeva Quality vault, while enforcing the company's policies and regulations.

2. DUTIES AND RESPONSIBILITIES

- Oversee electronic Quality Management System (Veeva QMS);act as the point-of-contact for QMS technical support; function as key subject matter expert for such quality systems.
- Manage Veeva account requests, creation, and modifications.
- Manage the Veeva QMS state of compliance including change management and validation.
- Perform configuration and validation activities of Veeva Quality Docs
- Drive deviation/CAPA process from initiation, impact analysis, root cause analysis, investigation, CAPA planning, effectiveness track, to closure.
- Perform quality record review, quality trending, generate quality metrics, developtools, and establish KPI for the quality systems.
- Assist with preparation and facilitation of Management Review meetings.
- Assist in the performance of companywide internal & external auditing in accordance with GxP as well as regulatory inspections.
- Evaluate gaps of qualitysystem process and authorquality system documents.
- Review change control requests.



Prepare documents for QA department related activities.
- Facilitate Change Control Review Board meetings, including impact assessments, and ensure on time approval and closure of change controls.
- Coordinate training regarding regulatory requirements, quality agreements, and corporate processes using the electronic Learning Management System (Veeva Vault Training). Participate in knowledge and experience sharing in relation to compliance with company procedures, policies, and objectives.
- Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance.
- Implement process improvements or new processes. Formulate continuous improvement tools for QA compliance operations.
- Provide administrative back up for the Document Control Specialist for the electronic Quality Document Management system (Veeva Vault Quality Docs).
- Assist the Document Control Specialist during times of peak workload.
- Perform other duties, as assigned.

3. QUALIFICATIONS

- Bachelor's degree in a science or technical related field with 8+ years of work experience in QA and/or related experience in pharmaceutical or medical device industry with progressively increasing responsibility.




- Good understanding and working experience in quality management systems with experience in Veeva Vault QMS or a similar QMS with validated software.
- Good knowledge on the configuration and validation activities of Veeva vaults

(Quality Docs)

- Knowledge of US, EU regulations & guidelines, GMP manufacturing & production processes as related to API production (i.e., ICH Q7, Q9 and Q10). Working knowledge of 21CFR 210 & 211 and 21 CFR 11. GCP is a great plus.
- Hands on experience in deviation and CAPA management from initiation to closure including root cause analysis, investigations, CAPA planning, and effectiveness check.
- Quality trending, metrics generation, and KPI experience.
- Auditing experience with certification preferred.
- Inspection and readiness preparation experience. Interaction with regulatory bodies/authorities is a plus.
- Strong soft skills including structural & follow-up skills, oral and written communication skills, high degree of accuracy and attention to detail, ability to follow written and verbal instructions, great teamwork skills, and valuable time management skills.
- Can-do attitude with ability to work with limited supervision for routine tasks.
- Sound decision-making, strong problem-solving capability both technically and operationally.
- Advanced office software skills including excel, word, and Power Point. Visio and project a plus.

4. WORKING CONDITIONS

This position operates in an office setting, in person.

Job may additionally require incumbent to be available outsideof these hours to handlepriority business needs.

5. PHYSICAL REQUIREMENTS

This is a largely sedentary role.

6. DIRECT REPORTS

N/A

📌 Quality Systems Specialist (India)
🏢 Ocugen India
📍 India