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0.0 - 4.0 years
2 - 4 Lacs
ahmedabad
Work from Office
Job Title: Junior Auditor - Quality Assurance (QA) Department Job Summary: The Junior Auditor in the QA Department assists in performing internal quality audits to ensure compliance with company policies, industry standards (e.g., ISO, GMP, FDA), and regulatory requirements. This role involves document review, data analysis, audit preparation, reporting, and follow-up on corrective and preventive actions (CAPAs). Key Responsibilities: Audit Support & Execution: Assist in planning and conducting internal audits for various departments to verify compliance with quality standards. Participate in process and system audits under the guidance of senior auditors or QA managers. Support the audit lifecycle including scheduling, data gathering, fieldwork, reporting, and follow-up. Documentation & Reporting: Review quality documents, standard operating procedures (SOPs), and records for completeness and compliance. Document audit findings clearly and concisely. Assist in preparing audit reports and tracking corrective actions to closure. Regulatory Compliance: Help ensure compliance with applicable regulations such as ISO 9001, GMP, GLP, FDA, or other relevant standards. Stay updated on regulatory changes and support the QA team in implementing necessary updates. Data Analysis & Review: Collect and analyze QA data, including trends in non-conformities, CAPA effectiveness, and risk assessments. Assist in monitoring key quality metrics. Support Continuous Improvement: Provide input on quality improvements based on audit findings. Assist QA team in implementing process enhancements and best practices. Qualifications: Education: Bachelors degree in Quality Management, Life Sciences, Engineering, Pharmacy, or a related field. Experience: 02 years of experience in quality assurance, quality control, or internal auditing (internships or co-op positions acceptable). Exposure to quality standards (ISO, GMP, etc.) is a plus. Skills: Strong attention to detail and organizational skills. Ability to work independently and as part of a team. Basic understanding of QA principles and auditing methodologies. Good written and verbal communication skills. Proficient in Microsoft Office (Word, Excel, PowerPoint). Preferred Qualifications: Knowledge of document control systems. Familiarity with risk-based auditing. Coursework or certifications in quality management or auditing (e.g., ISO 9001, GMP). Experience using audit management software or tools.
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
rajasthan
On-site
As a Qualified Person (QP) at PCI, you will play a crucial role in certifying investigational medicinal products in compliance with the requirements of the Investigational Medicinal Product Dossier (IMPD) and Product Specification File (PSF). Your responsibilities include ensuring the compliance of all batches to EU Directives, Annex 16, and Detailed Commission Guidelines related to Investigational Medicinal Products (IMPs). You will provide direct support and guidance to the Quality management team to ensure that Quality operations meet the necessary site safety, quality, and cGMP requirements. Additionally, you will participate in cross-functional teams to offer consultative support on quality-related issues and maintain programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs). Your role will involve reviewing batch documentation to ensure compliance with relevant product specification files and regulatory standards, as well as certifying completed batches efficiently. You will monitor the application of quality standards, facilitate investigations, provide CAPA recommendations, and support change control impact assessments. Furthermore, you will be responsible for collaborating with contract manufacturers, resolving compliance issues in supply chains, and completing third-party contractor and supplier quality agreements. You will also provide audit support for Health Authority Inspections, internal audits, and supplier audits, ensuring timely resolution of any observations. In addition to your operational responsibilities, you will contribute to quality projects and continuous improvement initiatives. This includes providing support to QA reports, offering quality direction for projects, updating technical agreements, and implementing new product introductions. You will maintain an up-to-date knowledge of pharmaceutical legislation and industry practices and actively promote best practices in quality methods. To be successful in this role, you should hold a Bachelor's degree in science, engineering, technology, or a related discipline, along with at least 3-5 years of experience in a quality management role in the Pharma industry. Qualified Person status or eligibility for QP status is required, and clinical experience is desirable. Strong organizational, time management, interpersonal communication, and decision-making skills are essential, along with the ability to work effectively under pressure and on your initiative. If you are looking to make an impact in the pharmaceutical industry by ensuring the quality and compliance of investigational medicinal products, join us at PCI and be part of building the bridge between life-changing therapies and patients. Let's talk about the future together.,
Posted 4 weeks ago
8.0 - 12.0 years
0 Lacs
pune, maharashtra
On-site
The position of QA & Testing Portfolio Manager, VP in Pune, India within the Risk & Control department of Corporate Bank (CB) Operations involves leading and implementing a quality assurance (QA) program for high-risk manual processes. The role requires conducting reviews of manual processes, identifying exceptions, and areas for remediation, as well as reporting results to senior management. Additionally, the Portfolio Manager will collaborate with coverage areas to enhance controls, revise policies/procedures, and address training needs. Key responsibilities of the role include leading QA reviews of complex high-risk manual processes across various Corporate Bank Operations units, utilizing quantitative and qualitative methods to measure quality outcomes, providing consolidated management information to key stakeholders, reporting summaries of QA reviews, monitoring exceptions and self-identified issues, maintaining documentation, developing standard templates, assessing process controls, identifying process improvement opportunities, managing a team of reviewers, and reviewing remediation of audit issues. The ideal candidate for this role should possess significant experience in QA principles, conducting effective QA reviews, maintaining objectivity, building effective relationships with operational teams, demonstrating analytical and problem-solving skills, communicating effectively with senior management, collaborating with individuals at all levels, making informed decisions, operating in a global business environment, and proficiency in MS Office programs. The successful candidate will benefit from a range of employee perks, including a best-in-class leave policy, gender-neutral parental leaves, childcare assistance benefit, sponsorship for industry certifications, employee assistance program, hospitalization and life insurance, health screening, training and development opportunities, coaching from experts, and a culture of continuous learning. Deutsche Bank fosters a positive, fair, and inclusive work environment where employees are encouraged to excel together every day. For further information about Deutsche Bank Group and its teams, please visit the company website at https://www.db.com/company/company.htm. The organization values responsible actions, commercial thinking, initiative, and collaborative work to achieve success and celebrates the accomplishments of its employees.,
Posted 1 month ago
8.0 - 12.0 years
0 Lacs
pune, maharashtra
On-site
The QA & Testing Portfolio Manager, VP position at Deutsche Bank in Pune, India is a crucial role within the Risk & Control function of Corporate Bank Operations. As a senior Quality Assurance Lead Reviewer, you will be responsible for overseeing and implementing a quality assurance (QA) program for high-risk manual processes across Corporate Bank Operations. Your key responsibilities include leading QA reviews of complex manual processes, measuring quality outcomes, providing management information to stakeholders, reporting on QA reviews, identifying exceptions and self-identified issues, developing standard templates and procedures, evaluating process controls, supporting process improvement opportunities, managing a team of reviewers, and reviewing remediation of audit issues. To excel in this role, you should possess a solid understanding of QA principles, experience in conducting effective QA reviews, objectivity in assessing processes, strong analytical and interpersonal skills, effective communication abilities, collaboration skills, problem-solving capabilities, familiarity with operational and IT environments, proficiency in MS Office programs, and adaptability to a fast-paced environment. The role also requires experience in a global business environment and the ability to share knowledge and expertise with team members. Deutsche Bank offers a range of benefits to support your well-being, including a comprehensive leave policy, parental leave, childcare assistance, sponsorships for certifications and education, employee assistance programs, insurance coverage, health screenings, training and development opportunities, coaching from experts, and a culture of continuous learning. The organization promotes a positive and inclusive work environment where employees are empowered to excel together every day. For further information about Deutsche Bank and its teams, please visit the company website at https://www.db.com/company/company.htm. The organization values responsibility, commercial thinking, initiative, and collaboration, aiming to achieve success together as the Deutsche Bank Group. Applications are welcome from all individuals who contribute to a positive, fair, and inclusive workplace culture.,
Posted 1 month ago
0.0 - 4.0 years
0 Lacs
noida, uttar pradesh
On-site
The Quality Assurance (QA) II Software Tester - Fresher position at TestOrigen Software Testing Services Pvt. Ltd. in Noida is an exciting opportunity for fresher candidates to kickstart their career in quality assurance. At TestOrigen, we are dedicated to providing high-quality software testing and QA services to our clients worldwide, and we are looking for enthusiastic individuals to join our team. As a QA Tester, you will have the chance to work closely with experienced QA professionals, gaining hands-on experience in software testing. You will be responsible for assisting in the development and execution of test cases, scripts, and plans, as well as identifying and documenting software defects. Collaborating with the development team to resolve issues, you will perform functional, regression, and smoke testing to ensure software quality and compliance with established standards. To excel in this role, you should possess a basic understanding of software development and QA principles, along with familiarity with different types of testing such as manual, functional, and regression testing. Strong analytical and problem-solving skills, attention to detail, and a commitment to quality are essential attributes. While knowledge of software testing tools is a plus, excellent communication and teamwork skills are key to success in this role. At TestOrigen, we offer a dynamic learning environment with opportunities for career growth, mentorship, and training to help you thrive in the QA testing field. You will have exposure to a variety of software testing projects and methodologies, supported by a collaborative and supportive team culture. This is a full-time position with day shifts from Monday to Friday in Noida. As part of our benefits package, food will be provided, and you will have the opportunity to earn performance and yearly bonuses. If you are a B.Tech (CS, IT, ET) or MCA fresher looking to launch your career in quality assurance, we encourage you to apply and be part of our team at TestOrigen Software Testing Services Pvt. Ltd.,
Posted 1 month ago
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