We are looking for QC e-Stone Information Technology

3.0 - 7.0 years

0 Lacs

vadodara, gujarat

On-site

As an experienced professional with over 3 years of experience in Computer System Validation (CSV) and IT quality assurance within regulated industries such as pharmaceuticals, biotechnology, or medical devices, you will be responsible for developing, executing, and documenting CSV protocols and reports for both new and existing computer systems and software applications. Conducting risk assessments and gap analyses will be a key part of your role to identify potential quality issues and implement necessary corrective actions. Your responsibilities will also include developing and maintaining quality documentation, such as Standard Operating Procedures (SOPs), validation plans, test cases, and reports. You will actively participate in the selection, implementation, and qualification of new IT systems and software, while providing training and guidance to users on CSV and IT quality best practices. Collaboration with cross-functional teams, including IT, engineering, and manufacturing, will be essential to ensure compliance with regulatory requirements. Staying informed about industry best practices and regulatory changes related to CSV and IT quality will be crucial in this role. Additionally, you will be involved in performing internal audits and supporting external audits related to CSV and IT quality. To be successful in this position, you should hold a Bachelor's degree in a related field and possess a deep understanding of GxP regulations, such as 21 CFR Part 11 and Annex 11, along with industry best practices for CSV. Experience with software development lifecycle (SDLC) methodologies and quality management systems (QMS) is required. Excellent written and verbal communication skills are essential, as you will be expected to effectively communicate technical information to both technical and non-technical audiences. Strong analytical and problem-solving skills are also important for this role. The ability to work independently as well as part of a team is necessary to excel in this position. If you meet these qualifications and are interested in this opportunity, please share your updated resume with ruchita.parsekar@e-stonetech.com.,

Posted 1 week ago

Apply

QC e-Stone Information Technology

3.0 - 7.0 years

0 Lacs

vadodara, gujarat

On-site

As an experienced professional with over 3 years of experience in Computer Systems Validation (CSV) and IT quality assurance within regulated industries such as pharmaceuticals, biotechnology, and medical devices, you will be responsible for the following key tasks: - Developing, executing, and documenting CSV protocols and reports for both new and existing computer systems and software applications. - Conducting risk assessments and gap analyses to identify potential quality issues and implementing corrective actions as necessary. - Developing and maintaining quality documentation including Standard Operating Procedures (SOPs), validation plans, test cases, and reports. - Participating in the selection, implementation, and qualification of new IT systems and software. - Providing training and guidance to users on CSV and IT quality best practices. - Collaborating with cross-functional teams (e.g., IT, engineering, manufacturing) to ensure compliance with regulatory requirements. - Staying updated on industry best practices and regulatory changes related to CSV and IT quality. - Performing internal audits and supporting external audits related to CSV and IT quality. To be successful in this role, you should possess the following qualifications: - A Bachelor's degree in a related field. - 3-4 years of experience in CSV and IT quality assurance within regulated industries. - Strong understanding of GxP regulations such as 21 CFR Part 11, Annex 11, and industry best practices for CSV. - Experience with Software Development Lifecycle (SDLC) methodologies and Quality Management Systems (QMS). - Excellent written and verbal communication skills, with the ability to effectively communicate technical information to both technical and non-technical audiences. - Strong analytical and problem-solving skills. - Ability to work both independently and as part of a team. If you meet the qualifications and are looking for a challenging opportunity to further develop your skills in CSV and IT quality assurance, we encourage you to share your updated resume with us at ruchita.parsekar@e-stonetech.com.,

Posted 1 week ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.