5 Qa Auditor Jobs

At Jubilant FoodWorks, we believe in a world powered by simplicity, flavour, and cutting-edge technology. We are the first in the industry to incorporate AI, IoT, and breakthroughs that push the envelope to author food-tech innovations. Trusted by global brands like Dominos Pizza, Dunkin (Coffee & Donuts), and Popeyes (Fried Chicken), we curate the best blend of food and technology for our consumers. We are powered by customer insights, striving today for a better tomorrow. Anchored by ambitions and a collective of believers, we are tempered by transparency and believe in growing together. We are dynamic and tech-driven, valuing each other's ideas. A marriage of two worlds - Food & Tech. At Jubilant FoodWorks, careers are carved to achieve milestones not just for the company but also for YOU. Come be a part of the FoodTech Powerhouse and shape the future of food and technology. We are looking for a Food Technology person for the role of QA auditor (support). This position may require travel. The salary offered is as per company norms. Freshers are welcome to apply for this exciting opportunity. If you are interested, please send your application to harishkumar.dhakate@jublfood.com. Join us in creating innovative solutions at the intersection of food and technology.,

QA Auditor

Knowledge of maintaining agricultural produce To maintain standards and specifications of all raw materials and finished products To assist in all areas related to product quality including troubleshooting, visiting, production, facilities, designing, training, quality control panel To provide information that is accurate, reliable and adequate for the intended purpose Keep the management team apprised of the quality issues Responsible for inspecting and documenting all incoming fruit, vegetables, packaging materials, and ensure all product quality standards are adhered to. Perform routine quality and condition inspections on existing inventory to assist in first-in, first-out (FIFO) or worst-in, first-out (WIFO) stock rotation. Ensure all inbound carrier trailers and materials meet company quality and food safety standards. Communicate Quality Assurance issues, including defect levels and problem loads, to Sales, Production, and QA managers. Verify customer specifications, quality requirements of product orders, documentation submitted and approved vendors. Coordinate inspections Maintain instruments, records of calibrations, and supplies as needed to meet quality inspection requirements to ensure that company standards are met. Work closely with Production and Warehouse departments to ensure effective stock rotation to reduce shrinkage. Maintain daily inbound inspection and defect reports , weekly inbound raw material reports and keeps accurate documentation for food safety purposes. Responsible for daily sanitation of equipment, and inspect repack products as needed. Ensure quality of product meets quality standards and communicate any inconsistency to sales, purchasing, management, and quality control department.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Core Purpose of the Role : To perform the role as Clinical QA auditor to verify compliance to ICH-GCP, NDCT Rule and other applicable regulatory requirements with respect to BABE/ Phase I studies. Comfortable working and communicating professionally with others to reach understanding and agreement as necessary. Other Responsibilities: To perform or assist any other relevant job with relevant training as and when required by Department Head or Management. Role Accountabilities: To perform study specific in-process audits as per audit plan to ensure that study is conducted in compliance with in-house SOPs, protocol and applicable regulatory guidelines etc., To perform study specific retrospective audits of informed consent document, study files like TMF, case report forms, raw data forms, draft clinical study report and other applicable documents to ensure that study is conducted in compliance with in-house SOPs, protocol and applicable regulatory guidelines etc., To perform database audits in EDC application for applicable studies. To prepare and issue audit reports to respective operations team in consultation with Manager/ Department Head and follow-up the implementation of CAPA to ensure timely closure of audit observations. To initiate change control and follow-up for the same for timely closure in consultation with Manager/ Department Head. To review change control, deviation and other QMS elements taken by operations team and follow-up for its timely closure. To review draft documents like Protocol, ICD, CRF etc., before its finalization. To assist for system audit as co-auditor and or providing input to Compliance QA team, if required. To perform vendor audit as lead/ co-auditor as per vendor audit forecast plan, if required. To review qualification and validation documents, if required by Manager/ Department Head. To assist and or participate whenever required as per Department Head discretion during system audit, internal and external audits and inspection as part of audit/ inspection readiness. To assist in preparation or reviewing the CAPA whenever required during system audit, internal and external audits and inspection. To ensure QA records generated are archived on periodic basis. To assist Manager/ Department Head whenever required to collate quality systems data for trending the Quality metrics. To escalate immediately to Manager/ Department Head in case of any serious non-compliance to protocol and ALCOA+ principles. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role 1. Experience: 6 - 9 years 2. Demonstrated Capability: Auditing skills, Understanding of regulations & Attention to detail 3. Education: M.Sc., in Life Sciences or M. Pharm., 4. Sound technical Knowledge in ICH GCP, NDCT Rule and other applicable guidelines.

JOB DESCRIPTION Job Title: Clinical Data Management QA Auditor Job Location: Semicon Park About Syngene : Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: To perform the role as a clinical data management (CDM) - QA auditor and be responsible for QA review or audits for clinical data management activities for BA/BE studies, phase I, II, III and IV studies To verify and assure compliance with ICH-GCP (E6 R3), study protocol, study data management plan (DMP)and other applicable regulatory requirements. To perform QA review and assist in development of standard operating procedures (SOPs) for clinical data management activities for BA/BE studies, phase I, II, III and IV studies. To perform QA review of study set up requirements such as CRF review and data base annotations in EDC platforms to assure study protocol requirements are fulfilled for phase I, II, III and IV studies. To perform QA review of study specific requirements, regarding CDISC and study data standards. To collate data for quality KPI metrics and report the trends for CDM related function. When indicated by Manager, perform vendor/sub-contractor qualification/surveillance audits (onsite/remote) and provide updates on audit outcome/closeout status and follow-up as indicated. Collaborate with CDM operations in lessons learned debrief sessions to identify the need for continuous improvement and for potential changes to work practices to create robust GxP quality systems. Escalate and consult with CDM operations regarding perceived GCP related vendor performance issues and when indicated consult them to develop a corrective and preventative (if applicable) action plan. Effectively plan & collaborate co-audits with compliance QA team to conduct scheduled & unscheduled QA system audits to ensure that clinical data management activities delivered by Syngene clinical development are of the Highest standards and are in compliance with the requirements of SOPs, Study protocols, relevant regulations & guideline. Follow-up of study/client/sponsor audits: Collect and review responses to audit observations and follow-up / escalate inadequate or delayed responses (CAPA) as necessary to ensure timelines are met and responses of satisfactory quality are obtained. Collaborate with the appropriate CDM Operations team members in follow-up, to the sponsor/client audits to ensure resolution of audit findings with the appropriate CAPA in accordance with GCP and other applicable regulatory requirements and relevant best GxP practices. Maintain quality records / systems: Maintain required Syngene QA tools and ensure Syngene QA systems are regularly updated with accurate information for audits and other activities. Facilitate clinical trial sponsor audits for clinical data management as assigned in collaboration with compliance QA team. Facilitate clinical trial regulatory inspections clinical data management as assigned in collaboration with Sponsor representative. Foster a good working relationship with internal and external stake holders to promote compliance within Clinical development operating unit for function conducting clinical data management activities for BE/BA & Phase I studies /patient based clinical trials. Working knowledge and expertise of Syngene policies, procedures, and guidelines, as well as applicable national and international regulations and requirements; able to apply them as needed Proactively recognize areas for process / procedural improvements, providing input to clinical data management function and taking the initiative, as appropriate to ensure implementation. Audit performance and reporting: Plan, schedule, conduct and report a range of GCP/GxP (CSV, 21CFR part 11) compliance audits in accordance with client requirements and Syngene/Sponsor procedures, independently or with minimal supervision. Perform and deliver high quality audits /audit reports within specified timelines / budgets. Lead or participate in co-audits / observed audits with client representatives or other QA auditors as and when required Travel nationally /internationally for QA audits as required. Ensure that the audit observation and findings are formally recorded & reported & that corrective/preventive actions are documented as per the QA SOP/ tools. Perform the assigned duties in an efficient & effective manner. This includes liaison with the project manager on all QA issues & provide support to project teams on GCP compliance aspects. When required shall author QA SOPs and shall perform QA review of cross functional operation s SOPs when required or assigned. Conduct training of Syngene staff regarding GCP, QA SOPs, the tool of QA & coordinate for proper implementation of respective SOPs. Provide support & resources for regulatory inspections & sponsor audits. Support GCP- Quality Head in planning/readiness and handling the trial site regulatory inspections/Sponsor audits as required. Quality and safety Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace always. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements always in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards always. Hold self and your teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Role Accountabilities: Accountable for the above-assigned role Leadership Capabilities: Must have advanced communication skills in English to interact with Cross functional and external stakeholders. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience: 8-10 Years Demonstrated Capability: as per the above role Education: M.Sc. / Any life science Postgraduates Experience: 8 -10 years Skills and Capabilities: Advanced computer skills (MS Office, MS excel, PowerPoint) and proficient in EDC platforms, self-motivated. Education M.Sc. / Any Life sciences Postgraduates Equal Opportunity Employer .