50 Equipment Validation Jobs

Experience in Vaccine/Injectable/Sterile manufacturing setup Review and evaluate facility, utility, process equipment & instrument design Prepare and review URS, DQ, FAT, SAT, IQ, OQ, PQ documents Conduct Computer System Validation (CSV) as per GAMP & 21 CFR Part 11 Coordinate with project teams to meet timelines and milestones Ensure compliance with GMP and regulatory standards Investigate deviations, failures, and non-conformances Identify root causes and implement CAPA Support audits and inspection readiness activities Job Location: Kadi, Gujarat ( Bus facility available for daily commute) Note: Immediate joiners will be preferred first

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

You will be responsible for equipment validation and Quality Management System (QMS) related activities. Your main duties will include the preparation, review, execution, and compilation of validation protocols for in-house Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of all equipment and systems used in Injectable production at the Indore site. Additionally, you will ensure that Periodic Performance Verification (PPV) is conducted and approved according to the PPV schedule. As part of your role, you will be required to manage a team and allocate tasks effectively. You will also oversee the QMS system, including handling change control, deviations, Corrective and Preventive Actions (CAPA) related to validation activities. In case of deviations and non-conformances identified on the shop floor, you will be responsible for conducting investigations and implementing corrective actions and CAPA within the specified timeline. Your commitment to Diversity, Equity, and Inclusion is highly valued in this role.,

As a Calibration & Quality Lead at Prism Group of Companies in Ahmedabad, Gujarat, India, you will play a crucial role in leading the quality and calibration department. Your primary responsibility will be to drive operational excellence, ensure ISO/NABL compliance, and oversee a team of calibration engineers to deliver trusted service to our diverse client base. You will be responsible for managing the end-to-end calibration process, including electrical, thermal, and dimensional aspects. Ensuring that NABL documentation, audits, and compliance are maintained up to date will be a key focus area. Additionally, you will conduct technical reviews, uncertainty calculations, and inter-lab comparisons to uphold technical excellence. Collaboration with the business team for client consultations and quotations will be essential, along with mentoring junior engineers and implementing Good Engineering Practices (GEP). You will design and execute internal quality checks and improvement initiatives to enhance our service delivery standards. Furthermore, coordinating with external assessors and regulatory bodies during assessments will be part of your responsibilities. To excel in this role, you should hold a Bachelors or Masters degree in Engineering, preferably in Instrumentation, Mechanical, or Electrical fields. A minimum of 5 years of experience in calibration labs with NABL/ISO standards is required, along with a strong understanding of ISO/IEC 17025 requirements. Expertise in uncertainty measurement, equipment validation, and method validation is essential, as well as possessing excellent team leadership, communication, and documentation skills. Preferred qualifications for this position include experience with calibration automation or digital systems, exposure to business development or client interaction, and being a certified internal auditor for ISO/NABL (preferred but not mandatory). If you are a dedicated professional with a passion for precision, integrity, and innovation in calibration and quality assurance, we invite you to join our team at Prism Group of Companies.,

Key Responsibilities: Demonstrate expertise in Body Shop Fixture Design using 3D/2D tools Validate guns and equipment for Body Shop applications Apply product and process knowledge in Body Shop Assembly Process Coordinate effectively with cross-functional teams Mentor junior engineers and provide technical guidance Collaborate as a strong team player to achieve project goals Required Skills and Experience: 3-6 years of experience in the Engineering Service Industry Proficiency in Body Shop Fixture Design (3D/2D) and Gun & Equipment Validation Hands-on experience with PLM, Team Centre, and NX software Knowledge of process planning is an added advantage Programming skills in Python or C# are a plus Strong coordination and mentoring abilities Qualifikationen Educational Qualifications: Bachelors / Masters degree in Mechanical, Automobile, or Production Engineering Preferred Qualifications (Good to Have): Exposure to process planning within automotive body shop environment Experience with programming languages such as Python or C# Familiarity with global engineering standards and PLM systems

The job involves preparing and analyzing samples from various sources in order to provide information on compounds or quantities of compounds present. This includes using analytical techniques and instrumentation such as gas chromatography (GC), high performance liquid chromatography (HPLC), and spectroscopy (ultraviolet) to investigate chemical compositions. Additionally, wet analysis will be performed. The responsibilities also include interpreting data, reviewing and evaluating experiments and analyses, and presenting scientific results to relevant teams. The role requires the development of new HPLC and GC methods, as well as collaborating with cross-functional teams. Staying up to date with the latest scientific and technical trends is essential, as well as validating methods and equipment. This is a full-time position that offers a performance bonus and yearly bonus. The work location is in person.,

Role & responsibilities Activities to be performed with the compliance of ISMS requirements by means of confidentiality, integrity, and availability. Data integrity must be followed and ensured in all the respective responsibilities. Audits: Sponsor Audits: Managing the sponsor audits as a whole, from pre requestees to close out meeting. Addressing audit observations within timeline. Follow up sponsors for certificates/clearance. Standard Audits: Ensuring the readiness for Audit. Supporting the cross functions for readiness requirements. Managing the audit from open meeting to close out meeting. Addressing the observations. Vendor Audits: Initiating the vendor qualification process based on requirements. Conducting onsite vendor audits with respect to ISO 9001:2015, ISO27001:2022 or other applicable ISO standards. Assessing the potency of vendors for iVRS service. Issuing audit observations, verification of CAPA and issuance of certificates. Verifying the surveillance audit due dates and initiating the surveillance audits within timeline. Score card updates for vendors. Internal Audit: Conducting Internal audit as per iVRS internal audit SOP, Ensuring the compliance with respect to internal SOPs, regulatory guidelines, etc Issuing the audit reports, verification of CAPA, closing the Audits. MRM: Facilitating the MRM upon completion of Internal audit under MR supervision Requesting cross functional inputs Making the MRM presentation Analytical Development: Develop documentation and system as per Quality Management System and ensure its implementation in the laboratory. Preparation of manuals and policies. To review the Manuals, Standard Operating Procedures, and other quality documents and approval of the same. Review and Approval of study protocols, Validation protocols, Qualification protocols and CSV protocols Review and approval of Validation reports, Qualification reports and CSV execution and reports. Develop, implement, and manage processes to ensure that studies / project activities meet required specifications for quality, function, and reliability prior to submission of data to the sponsor/customer. Review and approve of project / study documents related to analytical department to ensure its compliance with inhouse SOPs, study specific protocols, and applicable regulatory requirements & guidelines. Monitoring and ensure that the lab is following practices/ procedures laid down by way of regular planned and unplanned audits. Customer query- to register the query received from customer and handling the investigations Review, monitoring and data compilation of customer queries. Implementing, maintaining and improving the established analytical lab and in-process processes and methods. Verifying and approving the Laboratory incidents and investigations To oversee the activities with respect to Quality Management Systems and Learning and Development. Verification and approval of calibration documents. Verification of Audit trials in various instruments for validation, study and calibrations. Verification of biannual audit trails Attending all mandatory trainings (as applicable) without fail. Clinical Development: Conduct inspections or test checks to determine if all studies are conducted in accordance with the Principles of Good Clinical Practice Review of protocol and other study related documents Site visits whenever required. QMS: Verification of Procedures for its adequacy, To review and approve master list of SOPs. (as a backup to the designated employee) Preparation of new procedures and revision of existing procedures. Preparation, review, approval of Quality assurance procedures. Review and approval of cross function procedures. Verification, authorization/approval/Closure of Change controls, LIR and other QMS forms. Verification and approval of QMS trending. Review IQ, OQ, PQ records, Calibration certificates and Computer System Validation for Automated Software, as per 21 CFR Part 11 compliance. Ensure to follow and accomplish the Quality Objectives and ISMS objectives. Preparation / Verification of QA and ISMS objectives and actuals, Actuals, Risk assessments, Asset lists, etc Training: Ensuring the annual training schedule. Ensuring the mandatory trainings are conducted as per schedule. Ensuring the identified trainings are conducted for team members. Planning regulatory and QA trainings. Conducting BCP-DRT meetings. Ensuring the surveillance audits and ensuring the internal feedbacks.

Role & responsibilities Complete knowledge of Validation ( AHU / Autoclave / Dry Heat Sterilizer etc ) and Calibration -Capable of Compiling the Validation and calibration Activities -Good Computer Skill Preferred candidate profile CLEAN SHAVEN MALE CANDIDATE WITH MINIMUM 2-3 YEARS EXPERIENCE IN STERILE INJECTION SECTION

Job Title: CQV Engineer Location: Bangalore Experience: 3-4 years in pharma CQV 1. Commissioning Activities: Authoring of commissioning protocols (e.g., Installation Checks, Functional Testing) for equipment and Utilities such as Reactors, centrifuges, dryers, HPLC etc. Participate and coordination with engineering & OEMS for FAT/SAT. Authoring of DQ, System Impact Assessment and Risk Assessment documents in coordination with OEM. 2. Qualification and Validation: Author, review, and execute qualification protocols: Installation Qualification, Operational Qualification, and Performance Qualification for process equipment. Perform Qualification as per the regulatory requirements (e.g., FDA, WHO). 3. Documentation: Should have sound knowledge in good documentation Practices and QMS process throughout the CQV lifecycle. Coordination with engineering, manufacturing, QA/QC, and IT teams to coordinate CQV activities and ensure seamless project execution. Provide technical input during project planning and scheduling of CQV activities. Track and report progress of CQV milestones, and support. Good knowledge in project management and excellent communication as well as writing skills

Job Title: Quality Assurance Officers (4 Positions) Company: Nourish Pharmaceutical Pvt Ltd Location: Kheda, Gujarat Job Type: Full-time Nourish Pharmaceutical Pvt Ltd is a leading pharmaceutical company committed to delivering high-quality products. We're expanding our Quality Assurance team and looking for talented professionals to join us. Positions: 1. Quality Assurance Officer - Production 2. Quality Assurance Officer - QMS 3. Quality Assurance Officer - Validation & Qualification 4. Quality Assurance Document Control Officer Job Descriptions: 1. Quality Assurance Officer - Production - Key Responsibilities: - Ensure cGMP compliance in production areas - Manage and review Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and Master Formula Records (MFRs) in Pharma Cloud - Conduct in-process quality checks and documentation - Verify dispensing activities and line clearance - Collaborate with production team to ensure quality and compliance - Core Skills: - Attention to detail and analytical skills - Strong knowledge of cGMP, SOPs, and quality control procedures - Excellent communication and interpersonal skills - Experience & Qualification: - 0-3 years of experience in a similar role within the pharmaceutical industry - B.Pharm or M.Pharm degree in Pharmacy or a related field - Certification in quality assurance or a related field is an added advantage 2. Quality Assurance Officer - QMS - Key Responsibilities: - Manage deviations, CAPAs, and document handling - Ensure compliance with Quality Management System (QMS) standards - Conduct internal audits and facilitate external audits - Review and update SOPs, policies, and procedures - Collaborate with departments to ensure quality and compliance - Core Skills: - Strong analytical and problem-solving skills - Excellent communication and interpersonal skills - Ability to work independently and prioritize tasks - Experience & Qualification: - 1-3 years of experience in a similar role within the pharmaceutical industry - B.Pharm or M.Pharm degree in Pharmacy or a related field - Certification in quality assurance or a related field is an added advantage 3. Quality Assurance Officer - Validation & Qualification - Key Responsibilities: - Plan, coordinate, and execute validation and qualification activities - Ensure compliance with validation and qualification protocols - Review and approve validation reports and documentation - Collaborate with departments to ensure quality and compliance - Identify and mitigate risks associated with validation and qualification - Core Skills: - Strong knowledge of validation and qualification procedures - Excellent analytical and problem-solving skills - Ability to work independently and prioritize tasks - Experience & Qualification: - 1-5 years of experience in a similar role within the pharmaceutical industry - B.Pharm or M.Pharm degree in Pharmacy or a related field - Certification in validation and qualification or a related field is an added advantage 4. Quality Assurance Document Control Officer - Key Responsibilities: - Manage and maintain document control system - Implement and maintain change control system - Issue and maintain logbooks and records - Ensure plant and product documentation is accurate and compliant - Collaborate with QA team to ensure document accuracy and compliance - Core Skills: - Attention to detail and organizational skills - Basic knowledge of cGMP and quality control procedures - Excellent communication and interpersonal skills - Experience & Qualification: - 0-2 years of experience in a similar role within the pharmaceutical industry - B.Pharm, B.Sc or M.Pharm degree in Pharmacy or a related field - Certification in validation and qualification or a related field is an added advantage - All positions open for Fresher B.Pharm or M.Pharm degree in Pharmacy, Willingness to learn and grow in a quality assurance role How to Apply: If you're a motivated and detail-oriented individual with a passion for quality assurance, please submit your resume to info@nourishpharma.com

• Execute product/prototype testing as per SOP/WI and protocols. • Prepare specimens, samples, and test equipment setup. Record, interpret, and analyze data; prepare test reports. Required Candidate profile Operate and maintain lab equipment; perform calibration and maintenance activities. Ensure strict compliance with safety procedures, GLP, GDP, and 5S standards

Job summary We are looking for an individual to perform filling/washing and sterilization operations within GMP (Good Manufacturing Practices), regulatory, and organizational guidelines. The objective is to produce products within defined volumes and timelines, ensuring compliance with quality standards, GMP, and regulatory requirements as per schedule. Roles & Responsibilities - Perform filling, washing, sterilization operations as per the day plan, executing batch production records. - Participate in filling area line clearance activities and perform machine cleaning operations. - Handle material dispensing and issuance from the warehouse. - Issue discrepancies, work with cross-functional departments to close discrepancies, and implement appropriate corrective actions. - Compliance with GMP, safety standards, and SOPs (Standard Operating Procedure) for designated manufacturing equipment. - Maintain records in machine operation log books. - Maintain manufacturing equipment to ensure correct functionality and calibration compliance. - Actively engage in validation and qualification activities for all manufacturing area machines. - Promote safety awareness and improvements, engage in continuous improvement activities, and adhere to the company's safety rules. - Report all unsafe matters, near misses, and accidents. Qualifications Educational qualification and work experience Educational qualification: A Diploma or B.Pharm. Minimum work experience: 4 to 6 years of experience in batch formulation operations Skills & attributes Technical Skills - Proficiency in comprehending and overseeing sterile and fill finish operations in pharmaceutical manufacturing, demonstrating familiarity with the processes involved. - Practical experience and hands-on knowledge in executing sterile and fill finish operations, showcasing the ability to actively participate in and manage these critical manufacturing processes. - Practical expertise in equipment validation, process validation, and cleaning validation, demonstrating the ability to validate and ensure the reliability of manufacturing equipment and processes. Behavioural skills - Effective listening skills, ensuring a comprehensive understanding of information. - A keen eye for detail, ensuring accuracy and precision in tasks. - Awareness and sensitivity to deadlines, ensuring timely completion of tasks. - Analytical skills and the ability to troubleshoot, enabling effective problem-solving. - Strong interpersonal skills and the ability to work well in a team, fostering collaboration and positive team dynamics. About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. The World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such factories of the future is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddys we actively help to catalyze your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddys why they come to work every day and they'll say, because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions.,

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Issuance & retrieval of BPCRs/ ECRs/ formats/ log books etc. Preparation of QA SOPs and list of SOPs. Follow-up cross functional team for periodic review and review of other departmental SOPs as and when required. Distribution of controlled documents e.g. SOPs, specification etc. QC Analytical Raw data and sampling and review checklist Issued. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline

At Cepheid, we are dedicated to enhancing healthcare by providing rapid and precise diagnostic testing solutions. Our relentless mission inspires us every day as we strive to develop innovative and scalable technologies to address the most challenging health issues worldwide. Join our team and be part of the journey to revolutionize molecular diagnostics from concept to delivery, ultimately improving patient outcomes in various healthcare settings. Working with us offers you the opportunity to make a significant global impact in an environment that nurtures professional growth and advancement. As a Process Engineer, your primary responsibility is to develop and implement strategies to enhance continuous process performance in terms of Safety, Quality, Delivery, and Cost within a manufacturing process or production line. You will drive continuous improvement initiatives, oversee equipment and process performance, conduct validations, and troubleshoot issues to optimize throughput capacity by mitigating constraints. Collaboration with global teams is essential in this role, as you will serve as the technical liaison to engineering and manufacturing teams in the US, Sweden, and India during the equipment/process lifecycle. Key Responsibilities: - Lead the planning and execution of installation and validation processes for new or existing equipment and products in compliance with company standards, IVD regulations, and GMP standards. - Prepare and maintain documentation in adherence to QMS requirements, including validation plans, SOPs, protocols, and reports. - Utilize continuous improvement tools to enhance production efficiency, reduce maintenance downtime, minimize inventory levels, and implement cost-saving initiatives. - Analyze test data to establish process or material specifications. - Conduct training sessions for Manufacturing personnel and peers on equipment processes, validations, quality requirements, and upgrades. Qualifications: - Bachelor's or Master's degree in biotechnology, electrical engineering, electronics, or related fields with a minimum of 3 years of manufacturing experience, preferably in the Medical Device/IVD sectors. - Proficiency in equipment and product validation for medical device manufacturing, including knowledge of mechanical design principles and machinery operations. - Experience working in a regulated environment (ISO, GMP, Medical Device regulations). Desired Qualifications: - Previous experience in a global work environment. - Excellent communication skills (written and oral) in English. - Strong analytical, problem-solving abilities, and technical acumen. - Familiarity with Lean manufacturing and Six Sigma methodologies. Join our dynamic team today and be part of a collective effort to accelerate the real-world impact of tomorrow's scientific and technological advancements. At Danaher, we celebrate diversity and recognize the value of unique perspectives that our associates, customers, and shareholders bring to our organization and the global markets we serve. Visit www.danaher.com for more information.,

As the Quality Control Manager for injectable products, your primary responsibility is to ensure the adherence to quality control procedures in compliance with cGMP and regulatory standards such as FDA and EMA. You will oversee the testing and release of raw materials, in-process materials, and finished products, ensuring the proper documentation and traceability of quality control processes. Leading and managing the quality control team is a key aspect of your role, where you will provide mentorship, training, and motivation to ensure the team's effectiveness. Daily coordination of activities, task assignments, and setting priorities to meet production schedules are essential tasks. Regular performance evaluations and fostering continuous improvement within the team are also part of your responsibilities. You will be in charge of supervising the inspection and testing of injectable products for stability, sterility, endotoxins, potency, and other specifications. Sampling of materials and products for testing, as well as reviewing and approving laboratory test results, fall under your purview. Ensuring regulatory compliance with local and international standards, managing quality audits, and inspections by regulatory agencies, and implementing corrective and preventive actions are crucial aspects of your role. Root cause analysis of quality-related issues, initiating corrective actions, and collaborating with other departments for issue resolution are also part of your responsibilities. Overseeing the qualification and calibration of QC equipment, ensuring validation of analytical methods, and maintaining accurate documentation of test results and quality-related activities are essential tasks. Leading initiatives for continuous improvement, developing training programs for employees, and maintaining industry standards and SOPs are also key responsibilities. To qualify for this role, you should have a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related field, along with 5-8 years of experience in quality control in a pharmaceutical or injectable manufacturing environment. Strong knowledge of cGMP, FDA, EMA guidelines, laboratory testing methods, and quality management systems is required. Strong leadership, organizational, and communication skills, problem-solving abilities, and attention to detail are essential skills for this role. Proficiency in Microsoft Office and quality control software systems is also necessary. Excellent decision-making skills, interpersonal skills, and a proactive approach to quality management and compliance are personal attributes that will contribute to your success in this role.,

IQ, OQ and PQ,execution of Facility, Utility, Equipment and Computer system qualification,Client schedules,Report daily activities and work completion status to Sr. Manager, Validation ,SOPs Validation, Qualification,Calibration activities

Roles and Responsibilities Responsible to design validation/ qualification strategies. Responsible for validation /qualification of processing equipment's, cleaning equipment's and testing equipment's on time. Responsible to review & approve of validation /qualification protocols and reports. Responsible for day to day validation planning and execution activity. Planning, Execution & Participation of aseptic process simulation activity. Responsible for process validations, hold time studies, thermal studies, transport validation, filter validation etc but not limited. Responsible to design, review, approve and implementation of departmental standard operating procedures. Responsible to review, approval and authorization of all standard operating procedure of the site. Responsible to approve specifications, standard test procedures and analytical work records. Responsible to approve master batch manufacturing records and master batch packing records. Responsible to integrate all the standard operating procedures and to design a quality system to prevent and correct quality related subjects. To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports. To handle the market complaints and to participate in product recall. Responsible to perform vendor audit & approve vendor for raw materials, packing materials, contract manufacturing facilities & contract testing laboratories. Responsible to finalize annual GxP / Technical training planner as per requirement and Its Plan, execution as planner. Responsible to conduct internal audit /self-inspection to ensure compliance to cGMP and other regulatory requirements. Responsible for regulatory & customer audits preparation, execution and its compliance. Responsible to review of annual product quality review, environment monitoring trends & water systems testing trends. Responsible to co -orientate with internal as well as external department personnel to maintain the CGMP environment Responsible to update & maintain online departmental documentation. To ensure supply of products and service are having acceptable standards. To approve and authorize technical agreements from customer and outside party. To approve & authorize protocol received from outside party. Responsible to approve and authorize destruction of rejected materials/batches. Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department. Responsible to make the management aware of any deviation/non-compliance or any other quality related issues during validation/ qualification & processing. Responsible to inform top management for future requirement of departmental up-gradation necessary for the growth of organization and to meet regulatory requirement. To ensure the implementation of quality risk management procedures. To ensure that proper implementation of data integrity policies. Responsible to approve SMF, VMP, quality manual and project validation documents & release the batch after the compliance with the specifications in absence of Senior Manager QA. Desired Candidate Profile Candidate Should have experience in Injectable plant only Good Verbal & Written skill Proficient in Ms office/Excel & Word Perks and Benefits Medical Reimbursement Subsidized Accommodation for Bachelors Professional Development Paid time off Work/life Balance

Issuance & retrieval of BPCRs/ ECRs/ formats/ log books etc. Preparation of QA SOPs and list of SOPs. Follow-up cross functional team for periodic review and review of other departmental SOPs as and when required. Distribution of controlled documents e.g. SOPs, specification etc. QC Analytical Raw data and sampling and review checklist Issued. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline

You will be working as a Manager Surface Treatment in a listed Automotive Company based in Pune. Your role will involve planning and developing the paint and robotic painting process along with equipment validation for 2-wheeler and commercial vehicle parts. Your responsibilities will include: - Process planning which involves designing robotic painting processes, setting robotic painting parameters, standardizing processes for sheet metal and polymer parts, and achieving PQS-CTQ points. - Developing new color paints with the aim of minimizing coats, reducing costs, and achieving shade matching and PQS-CTQ. - Exploring AI-driven processes for efficient operations. - Ensuring defect-free and quick product introductions. - Implementing process improvements to reduce costs, enhance productivity, and shorten delivery times. - Establishing fool-proof manufacturing processes by incorporating necessary Poka-Yoke/interlocks. - Enhancing product quality by studying and resolving quality issues, improving process reliability, and improving aesthetics of visible parts. - Generating value analysis/value engineering (VAVEs) to reduce part costs and avoiding unnecessary capital investments. - Implementing green processes by standardizing painting processes through documentation and exploring resource conservation. If you are interested in this role, please share your updated CV with the required details mentioned. Your expertise in planning and developing paint & robotic painting processes along with surface treatment will be evaluated based on your total experience and academic achievements. Looking forward to your application. Best Regards, Swati Phenom Placement,

Hiring for the role of Documentation Job Title: Documentation Level Executive / Sr. Executive Experience: 3-5 Years Location: Ankleshwar Job Summary: The Documentation Engineer will be a key member of the execution team, responsible for managing and maintaining documentation related to installation, commissioning, and qualification of process and utility equipment. This role is ideal for mid-level professionals (3-5 years of experience) looking to advance their expertise in installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for equipment used in pharmaceutical, chemical, and food processing industries. Key Responsibilities: Prepare and maintain IQ, OQ, PQ documentation for micronizing mills, containment isolators, bulk handling systems, and fluid bed dryers. Ensure documentation aligns with industry GMP, FDA, and other regulatory standards for equipment validation. Support audits by maintaining structured records for qualification processes on day to day basis. Assist in the installation, commissioning, and qualification of high-containment and powder- handling equipment. Coordinate with internal teams and vendors for proper setup and troubleshooting of process equipment, Provide technical support for operation and maintenance of containment solutions. Work with senior engineers to troubleshoot automation systems, PLCs, and electrical components. Analyse equipment efficiency and contribute to continuous improvement initiatives. Maintain electrical consumption reports to optimize operational performance. Required Skills & Qualifications: Bachelor's degree in Engineering (Mechanical / Electrical / Chemical / Pharmaceutical) or relevant field. Hands-on experience with technical documentation processes and validation protocols. Strong understanding of process equipment installation and validation. Experience in project execution and vendor coordination. Familiarity with automation systems, PLCs, and process equipment troubleshooting. Proficiency in MS Office Suite, AutoCAD, and documentation software. If anyone is interested in this role kindly share resume to zalak.rohit@cielhr.com

Prepare Validation Master Plan(VMP, PVMP, CVMP, QMP).,Handling and storage of all quality document like BMR, BPR, log book, Protocol, Report and SOP throughout life cycle. prepare and review SOP. Monitoring of PPQ and cleaning validation activities.

You are invited to attend a walk-in interview at Zydus Biologics, Ahmedabad for the position of Warehouse Executive / FTE. As an Executive, you should possess an M.Sc./M. Com/ B.Sc. degree with 2-7 years of experience in GMP system. It is essential to have the ability to write QMS documents and demonstrate excellent knowledge of SAP, including proficiency in all T-Codes for tasks such as making GRN invoice, STO, and FG dispatches. You will be responsible for performing equipment validation and performance verification activities for the cell bank storage system, deep freezers, and temperature monitoring in the warehouse area. A solid understanding and experience in material management for raw material, consumable, API (DS), and drug product are required for this role. As a Fix Term Employee, candidates should have an HSC/ ITI qualification with 1-3 years of experience in handling and moving materials according to SOP. Responsibilities include material receiving, verification, documentation, dispensing/reconciliation of RMPM, and temperature and RH monitoring. The ability to perform cleaning activities is also essential for this position. If you are attending the interview, please remember to bring your latest resume, salary slips, CTC breakup, and all original academic documents. This opportunity is based in Ahmedabad, and the interview is scheduled for 12th July 2025 (Saturday) from 10:00 am to 3:00 pm at Zydus Biologics, Biotech Park, Opp. Ramdev Masala, Changodar Road, Ahmedabad-382213.,

Role & responsibilities Strategic Responsibilities: Define and govern the corporate CSV strategy across all units/sites for GxP systems, including SAP HANA. Lead enterprise-wide validation projects ensuring alignment with GAMP 5 , 21 CFR Part 11 , EU Annex 11 , and global data integrity expectations. Establish and monitor corporate SOPs, templates, and risk-based approaches for computer system validation. SAP HANA Specific Responsibilities: Lead validation of SAP S/4HANA (MM, QM, PP, and Z-reports, workflows, GRN process) across GxP operations. Prepare and maintain validation documentation including URS, Functional Specs, Test Scripts (IQ/OQ/PQ), RTM, and final reports for SAP HANA modules. Coordinate with IT, SAP consultants, and business users to ensure change management, role-based access control(RBAC), audit trail configuration, and secure workflows. Evaluate SAP-integrated systems (e.g.,LIMS, QMS, DMS) and their GxP compliance status. Cross-System & Governance Responsibilities: Ensure centralized control and compliance of all validated GxP systems across manufacturing, QC, QA, warehouse, and R&D operations. Conduct CSV risk assessments, gap analyses , and ensure mitigation plans are implemented across systems. Support system onboarding, upgrades, and infrastructure changes from a validation standpoint. Lead or support regulatory inspections and customer audits as CSV SME. Develop and lead training programs on computer system validation, data integrity, and regulatory compliance. Manage a team or act as a corporate mentor for site-level CSV resources. Preferred candidate profile: Technical Competencies: Strong knowledge of: SAP HANA MM, QM, PP, GRN workflows, custom Z-reports GAMP 5 / V-model SDLC / Agile methodologies 21 CFR Part 11 / EU Annex 11 / WHO / PIC/S data integrity guidance Soft Skills & Corporate Traits: Strong leadership and coordination skills for multi-site operations Excellent documentation, audit readiness, and training capabilities Capability to represent the organization in global audits and customer discussions Strong cross-functional communication with IT, QA, QC, Regulatory, and external vendors