6 Validation Activities Jobs

The Nonclinical Data Associate I is an entry-level position within the global data management solutions group, where you will be learning the tasks necessary for drafting and finalizing nonclinical datasets under supervision. In this role, you will have the opportunity to: - Learn appropriate methods of direct client contact - Prepare form letters and communication text - Shadow experienced data associates and participate in client site visits and conference calls - Utilize various software tools for efficient and accurate completion of job duties, including word processing, spreadsheet, dataset/table generation, collaboration/sharing, and database applications. Your primary responsibility will involve dataset preparation, which includes: - Obtaining and reviewing study documents such as protocols and reports to gather information for dataset preparation - Generating and quality checking dataset files to ensure compliance with regulatory requirements - Addressing client inquiries related to study datasets - Potentially compiling metadata for databases supporting nonclinical safety assessment - Learning software testing and validation activities, including executing test scripts and maintaining documentation in accordance with regulatory standards Additionally, you may be assigned other duties such as shadowing or attending company and industry initiatives related to dataset specifications and production. Labcorp is an Equal Opportunity Employer and encourages all individuals to apply. If you require assistance due to a disability when using our online tools or need accommodations during the application process, please visit our accessibility site or contact us at Labcorp Accessibility. For more details on how we handle your personal data, please refer to our Privacy Statement.,

As the Head of Corporate Quality in the Global Supply Organization at our base location in Navi Mumbai, India, you will play a crucial role in leading the development and execution of quality assurance strategies that are in line with our company's long-term objectives. Working closely with the Chief Technology Officer and the GSO Leadership Team, you will be responsible for ensuring the implementation of robust quality management systems, regulatory compliance, and driving continuous improvement in operational performance. Your responsibilities will include establishing best-in-class quality goals, analyzing quality metrics trends, implementing problem-solving strategies and system enhancements to achieve the desired levels of quality. You will lead and oversee the quality teams across all manufacturing facilities, focusing on continuous improvement initiatives. Team building will be a key aspect of your role, where you will be involved in establishing, inspiring, training, mentoring, and managing a team of QA professionals to adapt to new processes and tools effectively. Collaboration with business units to set quality targets for new and existing products, managing quality projects resulting from site consolidations or acquisitions, and working with the Quality Management System group to streamline and harmonize quality systems will also be part of your responsibilities. You will be responsible for maintaining the effectiveness of the Quality System across all Shalina manufacturing sites and Contract Manufacturing site, as well as implementing and monitoring an effective Vendor/Supplier development process. You will lead recruitment activities, ensure the professional development of direct reports and the overall company quality organization, and establish standards and metrics to support exponential growth while adhering to quality standards and regulatory guidelines. Additionally, your role will involve participating in various functional meetings, such as Supply Chain, Operational Excellence, and Sourcing, R&D. Your essential qualifications and experience include a degree in M.Pharm/B.Pharm/Master's in science, along with 15+ years of leadership experience in quality assurance, preferably in the pharmaceutical or life sciences industry. You should possess a strong understanding of ROW regulatory landscapes and international quality standards, exceptional commercial acumen, strategic business insight, and excellent consulting and communication skills to influence senior stakeholders effectively. Moreover, you should demonstrate personal credibility, strong interpersonal skills, integrity, dependability, and a results-oriented approach. Experience in working cross-culturally and cross-functionally with diverse colleagues is essential for this role. Your responsibilities will also include providing training efforts at Shalina sites as needed, advising and supporting alliance partners/service providers/central distribution center to ensure compliance with quality requirements, and offering immediate support during audits and compliance checks. In summary, as the Head of Corporate Quality, you will lead the development and execution of quality assurance strategies aligned with the company's goals, ensuring regulatory compliance, continuous improvement, and effective quality management systems across manufacturing facilities. Your role will involve team building, collaboration with business units, and maintaining compliance with global quality standards while supporting growth and customer satisfaction.,

The Quality Assurance (QA) Executive API (Bulk Drugs) role based in Savli, Gujarat requires a candidate with 2-5 years of experience and a qualification of B.Sc / M.Sc. As a QA Executive, your responsibilities will involve ensuring compliance with cGMP, ICH, and regulatory guidelines in API (bulk drug) manufacturing. You will be responsible for preparing, reviewing, and controlling SOPs, BMRs, BPRs, change controls, deviations, and CAPAs. In addition, conducting in-process checks for manufacturing and packaging activities, handling investigations for deviations, OOS/OOT results, and supporting root cause analysis are key components of this role. You will also be involved in participating in internal audits, regulatory audits (USFDA, EU, WHO, etc.), and vendor audits. Maintaining documentation for batch release, validation protocols, and quality systems, ensuring adherence to data integrity and good documentation practices (GDP), and supporting qualification and validation activities are crucial aspects of this position. Collaboration with cross-functional teams such as Production, QC, and R&D is essential for ensuring smooth operations. This is a full-time, permanent position with benefits including health insurance and Provident Fund. The work schedule is day shift with additional perks such as performance bonus and yearly bonus. The work location is in person.,

You should have 10 to 15 years of experience in Automotive system development. Your role will involve strong expertise in Hardware development life cycle activities and system Architectural activities. You should also have experience in Hardware engineering and a good understanding of Hardware safety, security, and ASPICE activities. You will be responsible for System development and validation activities, as well as quality processes and metrics. It is essential to have exposure to Hardware development infrastructure, Tools, and methods. This position is open for both Permanent role and Full-Time Consultant role. Join us and contribute your skills and experience to our team.,

As a Deputy Manager at Syngene International Ltd., your main responsibility will be handling QMS documentations like CC, CAPA, and Investigations, as well as managing EDMS documents, study protocols, and qualification protocols. You will be in charge of performing activities related to Engineering & maintenance at Biologics Unit 03 while ensuring GMP compliance and error-free operations. It will be crucial for you to follow all EHS requirements at the workplace to ensure individual and plant safety. Your role will involve completing all assigned mandatory trainings related to data integrity, health, and safety measures on time, and ensuring compliance to quality systems and current good manufacturing practices. You will play a key part in developing procedures and practices that promote safety operations compliant with company and regulatory norms, as well as adhering to Standard Operating Procedures and safety requirements. In terms of educational qualification, a Bachelor of Engineering degree is required for this position. You should have 9-12 years of experience in a relevant regulated environment. Technical skills such as handling QMS documentation, EDMS documents, system implementation, audit compliance, reviewing documents, and approvals will be essential for this role. Additionally, you will be responsible for performing preventive maintenance, equipment qualification, validation activities, equipment PM, utilities maintenance, SOP preparation, attending equipment breakdowns, maintaining critical spares, and more. Your behavioral skills should include good communication skills, both verbal and written, a high level of dedication, enthusiasm, motivation, and persuasive ability in a team and cross-functional environment. You should be able to work successfully in a dynamic, ambiguous environment, meet tight deadlines, prioritize workloads, and develop new ideas and creative solutions. Syngene International Ltd. is an equal opportunity employer dedicated to providing integrated scientific services to various industries globally.,

Role & responsibilities Job Responsibilities/Descriptions 1.0 Knowledge on Guidelines (ISPE, PDA, ICH) regulation (FDA & EMA). 2.0 Participate in Equipment, Area, Utilities and Facility qualifications. 3.0 Preparation and Review of URS, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Commissioning Studies, and SOPs related to Equipment/systems. 4.0 To monitor the Performance Qualification of various equipment and systems at site. 5.0 Review of Performance Verification protocols and reports. 6.0 To be part of process validations studies like Washing Validations, Mixing Validations, CIP and SIP validations, Filling Validations, Capping Validations, Autoclave, DHS Validations and providing support for preparation and review of summary report. 7.0 Review and verification of Calibration, Preventive Maintenance and Annual Maintenance records of equipments related to GMP Area. 8.0 Handling of Qualification related change controls, Deviation and CAPA initiation and closure. 9.0 Handling and knowledge on breakdowns, Notifications, and clearance request. 10.0 Basic knowledge on 21 CFT part 11 requirements. 11.0 Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. Identify and mitigate risks related to computerized systems at the site level. 12.0 Preparation and review of the SOPs related Qualification, validation (Including CSV) and review of Engineering SOP. 13.0 To ensure the Audit trails and data integrity compliance for GxP computerized systems. 14.0 Reviewing and approving (or rejecting) validation or qualification protocols and or reports. 15.0 Providing Quality oversight on engineering activities. Knowledge on Preventive maintenance and Calibration. Preferred candidate profile