Quality Assurance Executive Resume Samples

Description :

1. Reviewed and approved analytical method validation and transfer protocols, ensuring compliance with regulatory requirements and industry best practices.
2. Provided guidance and support in the execution of analytical method validation and transfer activities.
3. Reviewed and approved analytical test results, ensuring accuracy, completeness, and compliance with established specifications and procedures.
4. Performed investigations of out-of-specification (OOS) or out-of-trend (OOT) results and implemented appropriate corrective and preventive actions (CAPAs).
5. Ensured compliance with data integrity principles and Good Laboratory Practices (GLP) in analytical testing and documentation.
6. Participated in the qualification and calibration of laboratory equipment, ensuring proper functioning and adherence to quality standards.
7. Collaborated with cross-functional teams, including R&D, manufacturing, and quality control, to support analytical method development, optimization, and troubleshooting.

Experience

0-2 Years

Level

Entry Level

Education

BSc SE

Description :

1. Supported regulatory inspections and audits by providing necessary documentation and assisting in addressing any quality-related findings or observations. 
2. Assisted in the development and improvement of Standard Operating Procedures (SOPs) and quality control documentation related to analytical quality assurance.
3. Ensured that all products are manufactured and packaged by cGMP and other regulatory standards.
4. Worked closely with production teams to monitor and verify the quality of products throughout the manufacturing process.
5. Monitored the personnel competence according to their involvement within the Quality System. 
6. Maintained and improved the Quality System's effectiveness as far as compliance with the requirements of ISO 13485 Standard and other regulatory requirements are concerned.
7. Identified quality problems and promoted the appropriate corrections, and corrective and preventive actions to solve or prevent them.

Experience

0-2 Years

Level

Fresher

Education

BSc IT

Description :

1. Planned validation activities, implementation, generation of records, and archival.
2. Calibrated, verified, and adjusted Measuring Devices and Standards, or managed their external calibration and/or preparation.
3. Scheduled regular team briefings to impart generalized developmental parameters.
4. Participated in investigations of deviations and nonconformances and provided support for root cause analysis and CAPAs.
5. Ensured quality was maintained from warehouse to production, and packing.
6. Analyzed the performance of the in-house team of counselors and was responsible for channeling the relevant findings through effective feedback coordinated with the Assistant Manager.
7. Monitored, analyzed, and oversaw the process of counseling for all the counselors by quality check parameters

Experience

2-5 Years

Level

Junior

Education

BSc CS

Description :

1. Worked closely with production teams to identify and resolve quality issues in real-time.
2. Maintained accurate and complete documentation of all quality-related activities.
3. Participated in internal and external audits and inspections, and provided support for the preparation of responses to findings and observations.
4. Provided guidance and training to production personnel on quality-related topics.
5. Participated in the development and review of quality-related procedures and policies.
6. Able to control master documents and control the specification of manufacturing Formula, Filling, Labelling, and Assembly. 
7. Effectively assessed and closed (CA/PA), issue advisory notices, and carry out the process.

Experience

2-5 Years

Level

Junior

Education

BSc IT

Description :

1. Developed and implemented quality assurance policies and procedures.
2. Conducted regular audits and inspections to ensure compliance with regulatory standards and company policies.
3. Analyzed data and metrics to identify areas for improvement in product/service quality.
4. Collaborated with cross-functional teams to address quality issues and implement corrective actions.
5. Trained employees in quality standards and procedures.
6. Monitored and evaluated the effectiveness of quality assurance processes.
7. Ensured day-to-day QA Controls were in place and made QA empowered for the entire plant.

Experience

5-7 Years

Level

Senior

Education

BSc SE

Description :

1. Assisted with the management of ISO systems, coordinating and conducting internal system audits, conducting management reviews, and assuring the continual improvement of the system.
2. Coordinated system certification extensions and new standards certifications when required and carried out the necessary documentation.
3. Organized and carried out a regular inspection of the production process, reviewing, and verifying products and process conformities against the quality specifications.
4. Managed the internal food testing laboratory, issuing reports required, and calibrating laboratory equipment.
5. Assisted the Quality Assurance Manager in initiating new projects for quality improvements, such as sustainable development and cleaner production.
6. Analyzed data to find out the root cause of any customer complaints and internal non-conformities and proposed corrective action.
7. Conducted regular checks to see if the feedback given is implemented or not and analyze its effectiveness.

Experience

7-10 Years

Level

Senior

Education

BSc SE

Description :

1. Ensured implementation of verification activities of the HACCP plan. Control of monitoring and measuring equipment.
2. Ensured that documents in the QMS and FSMS systems and contract packing were updated and up to date.
3. Planned internal audits periodically, followed up with audit reports, checked for variances, and entered results into the system, to ensure the documentation in quality systems is current and accurate.
4. Evaluated manufacturing conditions and report on visits to senior management along with recommendations.
5. Ensured GMPs are followed in all areas of the manufacturing process to eliminate any kind of food-related risks.
6. Assisted in creating awareness of required hygiene levels of production personnel, and conducted spot audits to verify these conditions.
7.  Investigated and reviewed non-conforming events including customer complaints and internal non-conforming events and decided on CAPA and followed through for implementation.

Experience

10+ Years

Level

Management

Education

BSc SE

Description :

1. Prepared, reviewed, and implemented Standard Operating Procedures of Quality Assurance.
2. Ensured day-to-day QA Controls were in place and make QA empowered for the entire plant.
3. Ensured that processes needed for the quality management system were established, implemented, and maintained.
4. Ensured that a document control procedure was adopted to approve, review, and update all changes to documents within the scope of the Quality Management System.
5. Ensured that the performance of the Quality Management System is reviewed at planned intervals to ensure its continuing suitability, adequacy, and effectiveness.
6. Maintained the document as per current Good Manufacturing Practices.
7. Provided documents for regulatory affairs and handling of regulatory queries.
8. Investigated and reviewed non-conforming events including customer complaints and internal non-conforming events and decided on CAPA and follow through for implementation.

Experience

5-7 Years

Level

Executive

Education

BSc SE

Description :

1. Developed, implemented, and maintained comprehensive quality assurance programs to ensure compliance with regulatory standards, and conducted regular audits of production facilities, processes, and products.
2. Identified areas for improvement and ensured adherence to quality standards.
3. Maintained accurate records of quality control tests, audits, and other relevant documentation.
4. Ensured compliance with all applicable regulatory requirements, certifications, and licenses.
5. Identified opportunities for process optimization, efficiency enhancements, and cost reduction through continuous improvement initiatives. Implement best practices and innovative solutions to drive quality improvements.
6. Developed and implemented inspection activities, the detection and resolution of problems. 
7. Tracked and developed quality performance and initiated quality improvement plans. 

Experience

0-2 Years

Level

Freelancer

Education

BSc SE

Description :

1. Oversaw the implementation, maintenance, and improvement of ISO 9001 (Quality Management System), EMS (Environmental Management System), and EHS (Environmental Health and Safety) standards.
2. Coordinated with various departments to ensure compliance with ISO standards.
3. Prepared for and managed external audits by customers and certification bodies.
4. Developed and maintained documentation related to ISO 9001, EMS, and EHS standards.
5. Facilitated internal audits and managed corrective and preventive actions (CAPA).
6. Trained employees on quality management principles and ISO standards.
7. Ensured that PPAP (Production Part Approval Process) documentation is completed accurately and on time.

Experience

2-5 Years

Level

Executive

Education

BSc SE