6 Validation Documents Jobs

Day-to-day design and documentation activities (i.e. Validation Documents, DQ, IQ, OQ, Operating Instruction Manual etc. AutoCAD 2D Drawing (GA Drawing, Layouts, Part Drawing) Measuring Instruments & Basic Knowledge of Standard Mechanical Components.

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. To supervise all IPQA function activity on daily basis and update to QA Head as and when appropriate To ensure the all-time Audit readiness on the Shop floor. To ensure the data integrity is not compromised throughout the manufacturing activities of the Product. To review Master formula record and give feedback to the F&D. To ensure training of new procedures and current guidelines is provided to IPQA team members. To review monthly production plan and to ensure that required support is provided for smooth execution of the plan in co-ordination with cross functions. To suggest planning department in advance if any change is required. To review Good Documentation practice (GDP) or Good Manufacturing Practice (GMP) issues, analyze in coordination with cross-functional team members the impact on the product quality, strength, identity, and efficacy and suggest corrective actions, where necessary. To conduct daily morning meeting and review departmental activities and report to QA Head if any escalations To approve sample and/ or good destruction process and to review and report any gap to QA Head and take corrective and preventive action in co-ordination with respective functions. To respond to IPQA associated queries received from international regulatory affairs (IRA) department/business partner/regulatory agency, initiate change procedure as appropriate and report the queries and response to QA Head. To review and approve the instrument calibration failure records and ensure effective investigations done and CAPA taken in case of any abnormality observed. To review and Approve the CAPA, non-conformance, OOS, OOL investigation report, DCR, CCM and its extension. Participate in CAPA meetings and review summary report of the same within defined time monthly. To review the investigations for market complaint, out of specification, non-conformance investigation is completed in effective manner, on time and appropriately CAPA is established. To ensure that Document Change Request and Change Control documentation owned by IPQA is closed as per Standard Operating Procedure. To review/Approve, implement and update IPQA SOP's according to current regulations. To update the team about new procedures and current guidelines or changes in international regulatory requirements. To identify, monitor the non-conformity or abnormalities in process or in documents or in systems and ensure that those are captured and resolved according to Quality Management System. To ensure the continuous Audit trail and user access right verification review as per defined schedule. To allocate and monitor work assigned to the team. To prepare budget for purchase of all the requirements related to IPQA activities. To Review and Approval of the BMRs, SOPs, MFR, qualification protocols, miscellaneous protocols, qualification summary reports, CPV reports, APQR reports, CSV protocols and reports, risk assessments, facility drawings, layouts and related documents in TCU. To review and Approve Executed validation documents/ Trends summary reports and any other documents To review and approve miscellaneous study plans/protocols and cross-functional documents including rationale, risk assessments, engineering drawings, layouts. To halt the production in consultation with QA Head, Operations Head or Plant Manager- Manufacturing, if the GMP (Good Manufacturing Practices) requirements are not followed, and the quality is likely to be compromised. To communicate about any failure or abnormal notification (associated with product manufacturing and packaging activities) to QA Head for their attention. To ensure the implementation of audit commitments and its effectiveness. To review and approve the Breakdown Maintenance report of Maximo. To ensure the GQP Assessment and its implementation. To ensure the visual inspection qualification procedure followed as per applicable SOP. To ensure verification of the change parts before commencements of Batch for its cleaning and Physical appearance. To ensure the timely closure of CFS documents. To work as a designee of QA head and responsible for the allocated lines report to the QA Head. Any Other responsibility Assigned by QA head. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

As a Chemist at HEPL, a Group company of a 35-year-old FMCG Brand, you will be responsible for conducting various analytical tests and quality control activities in industries such as FMCG, Cosmetics, Foods, and Pharmaceuticals. You should hold an M.Sc. degree in Chemistry, Food Science, or Life Sciences with 0 to 5 years of relevant experience. Your primary responsibilities will include operating, calibrating, and maintaining various laboratory equipment such as UV-Vis spectrophotometer, K.F. Titrator, Conductivity meter, Viscometer, FT-IR, Tinto meter, Analytical balance, pH meter, GC, and HPLC. You should also have hands-on experience in handling Kjeldahl digestion and Distillation Unit, as well as in the preparation and maintenance of reference standards and volumetric standard solutions. In addition, you will be involved in quality control and quality assurance activities, including testing retained samples, spiked samples, and participating in inter-laboratory comparisons and proficiency testing programs related to skincare, hair care, hair color, specialty products, foods, snacks, dairy products, beverages, and bakery products. Furthermore, you will be responsible for preparing Standard Testing Procedures (STPs), validation documents, raw material, and product specifications. Good documentation and adherence to Good Laboratory Practices are essential aspects of this role. You should possess strong communication skills to effectively convey analytical results to both scientific and non-scientific stakeholders. The ideal candidate should have excellent written and oral communication skills in English and be able to join immediately. Prior experience in Research, NABL, and Laboratory settings will be preferred. The role is based in Ekkatuthangal, Chennai, and involves working full-time on day shifts from Monday to Friday. HEPL offers benefits such as health insurance and Provident Fund, along with yearly bonuses. If you meet the qualifications and requirements mentioned above and are keen on contributing to a renowned FMCG brand, we encourage you to apply for this position.,

You should have a Master's degree in Chemistry, Food Science, or Life Sciences with 0 to 5 years of experience in the FMCG/Cosmetics/Foods/Pharmaceutical industry. Your responsibilities will include operating, calibrating, performing intermediate checks, and maintaining various laboratory equipment such as UV-Vis spectrophotometer, K.F. Titrator, Conductivity meter, Viscometer, FT-IR, Tintometer, Analytical balance, pH meter, GC, and HPLC. Experience in handling Kjeldahl digestion and Distillation Unit, as well as preparing and maintaining Reference standards and volumetric standard solutions, is required. You will be involved in quality control and quality assurance activities, including testing retained samples, spiked samples, and participating in inter-laboratory comparisons and proficiency testing programs related to skincare, hair care, hair color, specialty products, foods, snacks, dairy products, beverages, and bakery products. Additionally, you will be responsible for preparing STPs, Validation documents, and Raw material/Product specifications. Proficiency in using Viscometer, Refractometer, and Tintometer is essential. Strong documentation skills and adherence to Good Laboratory Practices are necessary. You should possess excellent English written and oral communication skills to effectively communicate analytical results to both scientific and non-scientific team members. Immediate joining is required for this position located in Ekkathangal, Chennai. This job is with HEPL, a Group company of a 35-year-old FMCG Brand known for manufacturing popular products such as shampoos, hair colors, and food products like milk, milkshake, curd, and ghee. This is a full-time, permanent position with benefits including health insurance and Provident Fund. The work schedule is day shift from Monday to Friday, with a yearly bonus. To apply, you should have experience in Research, NABL, and Laboratory work for at least 1 year each. Immediate joiners who meet the educational and experience requirements are encouraged to apply for this role.,

You will be responsible for preparing validation documents, inspecting machines and parts, coordinating with production team, and assisting in the development of parts and machines. You will also be involved in organizing parts from vendors and developing new vendor relationships. Additionally, you will conduct inspections of machines at vendor locations. The ideal candidate should have a minimum of 1 year of experience in quality assurance or engineering, with a background in mechanical engineering or ITI. Knowledge in quality control and documentation is essential for this role. Performance will be appraised based on your contributions. Upon becoming a permanent employee, you will be eligible for PF benefits. We are looking for individuals who are committed to working in our organization for a long period of time.,

As a Project Engineer at Nilsan Nishotech Systems Pvt. Ltd., located in Navi Mumbai, you will be responsible for detailed project planning and scheduling. Your role will involve project coordination with various departments and clients, as well as project monitoring, controlling, and budget preparation. It will be crucial for you to execute projects within budget while ensuring cost control and project closure with thorough analysis and evaluation for continuous improvement and development. Your key responsibilities will include generating project deliverables, creating project plans, punching SOs, tracking materials, conducting FATs internally and externally, monitoring and controlling site activities, performing installation qualifications, and verifying interdepartmental documents for approval. Additionally, you will be expected to provide regular Management Information Reports (MIR). To excel in this role, you should have knowledge of Pharma processes, site construction processes, validation documents, and proficiency in tools such as MS Projects, Excel, Word, and ERP systems. The ideal candidate will have 1 to 2 years of experience as a Project Engineer handling WT projects or 3 to 5 years of experience as a Site Engineer managing WT systems, preferably within the pharma industry. Educationally, a Degree or Diploma in Engineering, preferably in Chemical or Mechanical fields, is required for this position at Nilsan Nishotech Pvt. Ltd. This growing project engineering company specializes in serving the Bio, Pharma, and Dairy industries by providing customised process piping, high purity water systems, membrane separation systems, and advanced separation/purification techniques like chromatography. Driven by a vision for high purity systems and engineering excellence, Nilsan Nishotech has established itself as a Solutions Provider with expertise spanning presales support, design, engineering, installation, commissioning, and FDA validation processes. The organization values excellence, participative management, and creating a creative work environment to nurture skills and people. To support its various functions and business expansion, the company is seeking young, dynamic, self-driven professionals with a strong creative streak. If you are interested in this exciting opportunity, please visit our company website at www.nilsan-nishotech.com and share your resume at hr@nilsan-nishotech.com.,