Zydus Pharma Quality Assurance – Qualification/Validation Job. Zydus QA Job.Pharma Job. Pharma candidates are encouraged to apply for a QA at Zydus Group. Zydus Group is hiring Pharma science candidates for QA posts as per the details. Check out more on Rasayanika.com
Job Title: Quality Assurance – Qualification/Validation
Designation : Executive
Reports to : QA Head
Department : Quality Assurance
Location : Zydus Technologies
No of Posts : 1
Key Job Description:
1. Responsible for preparation of the Validation Master Plan, Computer System Validation Master Plan.
2. To prepare and review of Design Qualification, FAT, URS, Validation protocols & Reports and Qualification protocols & reports.
3. To execute and supervise the qualification and Validation activities for equipment, PLC and utility services and their continuous performance.
4. To prepare & update Cleaning Validation Master Plan/cleaning validation/verification protocols/reports/matrix.
5. Responsible for ensuring the compliance with Validation Master Plan and requalification of utility, equipment, procedures and systems as per the frequency described in Validation Master Plan.
6. To ensure compliance to Preventive Maintenance Planner for the equipment.
7. To review of calibration certificates from SAP
8. To verify instrument calibrat
ion status.9. To review raw data /audit trail / software (as applicable) at a given frequency to ensure regulatory guidance compliance.
10. Responsible for preparation of risk assessment and mitigation plan.
Qualification we seek in you for Quality Assurance Job in Zydus ! :
Qualification: B. Pharma / M. Pharma / M. Sc
Years of Experience: 4-7 years
Experience in Zydus: 12/24 months
Experience / Exposure in: Equipment / Utility Qualification and Cleaning Verification/Validation
From which Dept. people can apply: Personnel with experience in Quality Assurance.
Mail your CVs to: [email protected]
Possible Interview Questions may we asked for Quality Assurance Job in Zydus
1. Can you explain your understanding of qualification and validation in the context of Quality Assurance?
Answer: Qualification and validation are essential processes in Quality Assurance. Qualification involves verifying and documenting that equipment, systems, and processes are suitable for their intended use. Validation, on the other hand, is the process of establishing documented evidence to ensure that a system or process consistently produces results that meet predetermined acceptance criteria. Both qualification and validation play a crucial role in ensuring the reliability, accuracy, and compliance of operations within a regulated industry.
2.How do you approach the qualification of equipment and systems?
Answer: When it comes to qualifying equipment and systems, I follow a systematic approach. Firstly, I assess the specific requirements and intended use of the equipment or system. I then develop a qualification plan that includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols. During the qualification process, I execute these protocols, document the results, and ensure compliance with regulatory requirements and internal standards. Regular calibration and periodic requalification are also integral parts of maintaining equipment and system qualification.
3. Can you describe your experience with validation protocols and procedures?
Answer: I have extensive experience in developing and executing validation protocols and procedures. I am well-versed in writing validation plans, creating validation protocols, conducting risk assessments, and performing validation activities such as protocol execution, data analysis, and report writing. I am familiar with industry guidelines, regulatory requirements, and best practices related to validation. Additionally, I have experience in managing and coordinating validation projects, ensuring effective communication and collaboration with cross-functional teams.
4. How do you ensure compliance with regulatory standards and guidelines during the qualification and validation processes?
Answer: Compliance with regulatory standards and guidelines is of utmost importance in qualification and validation activities. To ensure compliance, I stay updated with relevant regulatory requirements and guidelines from authorities such as the FDA, EMA, and ICH. I incorporate these requirements into the qualification and validation protocols, ensuring that all necessary parameters are addressed. I also conduct thorough documentation and record-keeping, adhering to Good Documentation Practices (GDP). Regular internal audits and quality checks are performed to identify and address any gaps in compliance.
5. Can you provide an example of a challenging qualification or validation project you have worked on and how you managed it?
Answer: In a previous role, I was involved in the qualification and validation of a complex manufacturing line for a pharmaceutical company. The project presented challenges such as tight timelines, multiple equipment interfaces, and stringent regulatory requirements. To manage the project effectively, I employed a risk-based approach by prioritizing critical aspects and focusing on high-risk areas. I collaborated closely with cross-functional teams, ensuring clear communication and coordination. By leveraging my organizational and problem-solving skills, we successfully completed the qualification and validation activities within the specified timeline, meeting all regulatory and quality requirements.
