98 Equipment Qualification Jobs

The responsibilities for this role include reviewing raw and finished product specifications, ensuring good laboratory practices in the Quality Control department, reviewing audit trial records, analyzing analytical records, reviewing instrument calibration and equipment qualification documents related to QC, validating analytical methods, verifying samples, handling reserve sample room, ensuring analyst qualification, reviewing working standards, managing deviations, change control, OOT, OOS, laboratory incidents, investigations, and annual trends, coordinating CAPA implementation verification and closure, reviewing instrument and equipment preventive maintenance, monitoring and recording temperature and humidity in the laboratory area, and managing document control. The ideal candidate should possess skills in audit trial, OOT, deviation handling, OOS, backup and restoration data management, sample handling, instrument maintenance, quality assurance, instrument calibration, laboratory practice, laboratory incidents management, change control, method edit forms, working standards review, analytical records analysis, quality control, document management, equipment qualification, stability protocols, analyst qualification, analytical method validation, CAPA implementation, and temperature monitoring.,

Seeking a CSV Consultant to work on a variety of validation projects including manufacturing systems, lab systems, risk assessments, etc. Some of the work may be done remotely, some at client sites and others at one of our offices. Immediate start date Job Responsibilities: Responsible for the Computer System Validation processes of the company Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11) Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule Lead system qualification efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply Minimum Requirements: Minimum degree requirement - Bachelor's degree with at least 10+ years of experience Must be willing to travel regionally and/or nationally throughout India Candidates must have excellent verbal communication and technical writing skills Experience in generation and execution of protocols and procedures related to different areas of qualification and validation Expertise in ISPE GAMP5, ICH Q8, ICH Q9, ICH Q10, 21 CFR Part 11, Computerized System Validation, Equipment Qualification, and Validation Change Control Working knowledge of protocol development for validation of complex computer systems (e.g., multiple GAMP classes of systems); ability to develop Installation, Operational, and Performance Qualification documents Experience in execution of system validation lifecycle deliverables Experience in project execution within at least one area of systems validation (e.g., laboratory equipment, facilities utilities, manufacturing equipment) Proficient in Microsoft Word, Excel, Power Point, and Project Ability to plan and manage own work All candidates must be legally eligible to work in India

To prepare and review Validation Master Plan QMP, VMP, PVMP, Handling and storage of all quality document like BMR, investigation. CAPA and all other quality management, CAPA Monitoring of PPQ, requalification activities, OSD

As a Sr. Executive / Assistant Manager Quality Assurance (QA) at SAVA Healthcare Limited, Surendranagar Plant, your primary responsibility is to ensure the implementation and maintenance of cGMP practices, quality systems, and compliance with regulatory requirements. You will oversee QA activities including documentation, validations, audits, and shop floor compliance to uphold product quality and regulatory adherence. Your key responsibilities will include ensuring compliance with cGMP, SOPs, and regulatory requirements on the manufacturing floor, reviewing and approving batch manufacturing records (BMRs) and batch packing records (BPRs), handling deviations, change controls, CAPA, and quality risk management activities, conducting self-inspections, and supporting external/internal audits. You will review and approve SOPs, protocols, and reports related to validation, qualification, and quality systems, monitor and support validation activities, oversee document control, ensure timely closure of audit observations and CAPA implementation, and coordinate with various departments to ensure overall GMP compliance. Additionally, you will participate in training programs and provide QA training to cross-functional teams. SAVA Healthcare Limited (SHL) is a diversified pharmaceutical company committed to delivering quality-driven pharmaceutical solutions globally. Established in 2003, SHL has a strong presence in International Business, Animal Healthcare, Herbal Products, and Contract Research & Manufacturing Services (CRAMS). The ideal candidate for this role should have a B.Pharm / M.Pharm / M.Sc. degree with 4 to 7 years of experience in QA in a regulated pharmaceutical formulation plant. You should possess a strong understanding of GMP guidelines, quality systems, validation practices, and regulatory audits. If you are passionate about maintaining high-quality standards, ensuring regulatory compliance, and contributing to the success of a leading pharmaceutical company, we encourage you to apply for this exciting opportunity at SAVA Healthcare Limited, Surendranagar Plant, Gujarat.,

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

As a Production Plant Operator/Technical Assistant at Zydus Lifesciences Ltd's SEZ 1 OSD Manufacturing Unit in Ahmedabad, you will be responsible for operating and maintaining equipment used in granulation, compression, coating, and capsule filling processes. For the Production Staff position, we are seeking individuals with a B.Pharm/M.Pharm qualification and 4-10 years of experience in market complaints handling and documentation. As a member of the Packing Staff, your role will involve managing packing operations with a focus on quality assurance. Candidates with a B.Pharm/M.Pharm qualification and 4-10 years of experience are encouraged to apply. Quality Assurance IPQA professionals with a background in B.Pharm/M.Pharm/M.Sc and 2-8 years of experience are needed to ensure compliance with IPQA, equipment qualification, and QA QMS standards. In the Engineering department, we are looking for Plant Operators/Technical Assistants with ITI/Diploma/BSc qualifications and 4-10 years of experience in process maintenance, utility operations, and electrical systems. If you meet the qualifications and have the required skills, we invite you to attend the walk-in interview at The Fern Kesarval Hotel on Verna Plateau, Kesarval Cortalim, Goa, Pincode 403710, on 03rd August 2025, from 09:00 am to 03:00 pm.,

: Review of R&D developmental data of ARD and PD like Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, Study Reports, for accuracy, data integrity and compliance to systems, procedures and regulatory requirements. Review of Technology Transfer documents like Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications and MOAs. Conducting routine laboratory rounds for ensuring compliance to Good Laboratory Practices. Handling of Change Controls, Deviations, Incidents and Laboratory Assessment Reports. Preparation, review of SOPs and conducting the SOP Training. Conducting training of R&D personnel on Good Laboratory Practices. Management of development stability samples i.e. protocol review, sample charging, stability calendar updation and sample withdrawal. Receipt, issuance and management of RLDs and Exhibit batch samples. Issuance of R&D documents like LNBs, Forms, Logbooks for routine use. Maintaining Document Archival room of R&D. Issuance of archived documents against request.Receipt of document for archival through document inward register. Receiving, storage, issuance and management of Working Standards, Reference Standards, Impurity standards and Chromatographic columns. Review and approval of Instrument/Equipment Qualification and calibration records. Skills Required: Quality Management systems | Expert Good Laboratory Practices | Advanced Analytical Method Development & Validation review | Advanced Product Development Report Review | Intermediate Internal Quality Audits | Intermediate Documentation Control | Expert Review of Specification and MoAs | Expert Stability Studies | Expert Change Control, Deviation, Incident and Laboratory Assessment Reports | Expert Training | Beginner USFDA, ICH, EMA Guidelines, USP General Chapters | Advanced

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

The Company Syngene International Ltd. is an integrated research, development, and manufacturing solutions company serving various sectors including pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemicals. With a team of over 4500 scientists, Syngene offers expertise in delivering high-quality science, robust data management, IP security, and efficient manufacturing processes. The company's facilities span over 1.9 million square feet, catering to leading biotech companies and multinational corporations such as GSK and Merck KGaA. Key Responsibilities Safety is a top priority at Syngene, and all employees are expected to prioritize safety in both personal and professional capacities. Compliance with safety guidelines, procedures, and SOPs is mandatory to ensure a safe work environment. Common Responsibilities - Adhere to Environment, Occupational Health, Safety, and Sustainability (EHSS) practices for a safe work environment. - Complete assigned trainings in a timely manner and comply with training procedures. - Participate in mandatory trainings related to data integrity, health, and safety. - Maintain compliance with Good Manufacturing Practices and Good Documentation Practices. - Follow Standard Operating Procedures and Operational Control Procedures. - Support training programs on procedures, protocols, and on-the-job activities. - Report nonconformities and deviations to supervisors or line managers promptly. - Participate in deviations, investigations, CAPA, and change controls as needed. Safety And DI Responsibilities - Follow organizational policies on EHSS, POSH, Data Integrity, and IT security. - Wear applicable Personal Protective Equipment (PPE) and adhere to EHS requirements. - Understand and follow safety protocols to prevent incidents. - Identify near-misses and potential incidents, and report them to supervisors. Specific Responsibilities - Adhere to aseptic behavior in Biologics operations. - Perform upstream activities including Assembly preparation, Media Preparation, Vial thaw, Feed preparation, and Bioreactor Operations. - Monitor and control specific Operations of the upstream processes. - Maintain Quality records and traceability of products. - Perform in-process product sampling and storage. - Review and prepare operation-related documents. - Take responsibility for the assigned USP area and equipment/instrument ownership. - Coordinate with QA for line clearance and maintain process areas for inspections. - Prepare procedures, protocols, risk assessments, and Batch Manufacturing Records (BMRs). - Execute protocols related to upstream activities and equipment/instrument qualification. - Review consumable stock and maintenance records. - Ensure timely closure of work orders and report nonconformities. - Participate in downstream activities under the supervision of downstream supervisors. Syngene International Ltd. is an Equal Opportunity Employer. Visit https://syngeneintl.com/ to learn more about the company and its operations.,

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products to serve underserved patients. With a focus on providing unique, accessible, and high-quality medications, Azurity continuously expands its commercial product portfolio and late-stage pipeline by leveraging integrated capabilities and a vast partner network. The company's patient-centric offerings span various markets including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, positively impacting millions of patients. As an inclusive workplace and Equal Opportunity Employer, Azurity attributes its success to a team of talented individuals committed to enhancing patient lives through a combination of cutting-edge science and unwavering dedication to quality. The company values highly motivated individuals with integrity, dedication, and creativity to thrive within its organization. The Technical Operations department at Azurity is responsible for overseeing technical process strategy, managing contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), and delivering product objectives in line with company policies and client requirements. This role involves leading teams, collaborating cross-functionally, and achieving project milestones to support process scale-ups, validation, technical transfers, post-approval changes, and investigations for commercial products. **Principal Responsibilities:** - Manage the planning and execution of manufacturing activities, including qualification and validation for both development and commercial products. - Coordinate with contract facilities to review, approve, and execute controlled documentation related to late-stage development, qualification, validation, and manufacturing activities. - Direct tasks associated with late-stage product/process development, product transfers, equipment qualifications, and validation to ensure alignment with company objectives. - Support or lead product launch and commercialization efforts. - Establish and maintain policies, SOPs, and documentation to support validation practices per regulatory requirements and industry guidance. - Assist in Management Review and Compliance activities, preparing metrics and summaries for senior management communication. - Support Due Diligence activities related to product development, technical transfer, manufacturing, and commercial launch. - Collaborate with cross-functional team members from Supply Chain, Product Development, Quality Assurance, and Regulatory Affairs. **Qualifications And Education Requirements:** - Bachelor's degree in Life Sciences (Master's degree preferred) or related field. - Minimum 15 years of experience in biopharmaceutical/pharmaceutical GMP environment or related industry. - Expertise in cGMPs, ICH, and Validation related requirements. - Proficiency in technical transfer of multiple dosage forms, various validation disciplines, and regulatory agency inspections. - Ability to work strategically, tactically, and hands-on. - Proficient in Microsoft Word, Excel, and Powerpoint. By applying for this role, you confirm your capability to fulfill the job responsibilities outlined in the job description without any restrictions. If you have any concerns or disabilities that may impact your ability to perform the job, please inform HR in advance.,

Job Description Candidate should have sound knowledge about upstream process development (Cell culture and Fermentation). Hands on experience of shake flask studies including sample analysis and documentation. Experience in handling and operation of cell culture and microbial related experiments in bioreactor including sample analysis and documentation. Aseptic handling of seed inoculum and its maintenance Independently handle media and feed preparation for conducting studies. Should be able to trouble shoot in case of any deviation from process/parameter. Good documentation practice. Should be able to perform cell culture (IPQC) analysis. Preparation of SOP, Support for Equipment qualification, Calibration pertaining to Upstream process as per laid down procedures Ensure quality compliance in Biotechnology Upstream laboratory as per Quality standards requirements

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

Job Description :- Maintenance Officer / Sr. Officer Scicore Nutra Private Limited is a state-of-the-art facility, located in Sanand Gujarat, is dedicated to producing high-quality nutrition products that are safe, effective, and meet the highest standards of quality. Our team of experts is committed to ensuring that every product we manufacture is produced with the utmost care and attention to detail. At our manufacturing unit, we use only the best raw materials and employ advanced manufacturing processes to ensure that our products are of the highest quality. We also adhere to strict quality control measures to ensure that every product meets our rigorous standards. This starts with doing a rigorous vendor qualification as well as testing of all raw materials supplied by these vendors for every batch. We do in-house stability studies to make sure our products last the full shelf life and give the best results to our customers. Our goal is to provide our customers with nutraceutical products that promote health and wellness, and we are committed to using science-backed ingredients and formulations to achieve this goal. We are also committed to continuous innovation and improvement and are always looking for new ways to enhance our products and processes. Benefits Provided: 1 free Air-Conditioned Transportation to the Factory 2 Paid Leave 3 Tea/Coffee & Canteen Facility 4 Accident Insurance 5 Provision for Bonus & Gratuity 6 Training programs for professional advancement 7 Progressive work environment conducive to personal and professional growth Job Title - Maintenance Officer / Sr. Officer Role & Responsibility Follow the cGMP and GDP Procedure. Develop maintenance procedures and ensure implementation. Carry out inspections of the facilities to identify and resolve issues. Plan and oversee all repair and installation activities. Keep generator, lighting and electrical system in working order. Diagnose problems and then repair/replace defective parts. Preparing all the documents (like SOPs, related log sheets, etc.) related to the maintenance department. Inspecting the validation and calibration activity of the clean room and other equipment as needed. Perform mechanical and electrical maintenance repair work; install/ replace fixtures, switches, motor, receptacles, and wiring. Execute PPM (Planned Preventive Maintenance) of equipment, maintains records and logs as needed. Provides guidance and directions to less experienced personnel and others assigned to his/ her position. Performs all work in accordance with all established regulatory and compliance as per safety requirements. Responsible to source, negotiate and purchase materials from local vendors. Evaluate vendor s quotation to ensure that they are in line with the technical specification required for the project. Any additional job responsibilities as assigned by HOD. Perform other various task as instructed by management. Department : Maintenance Number Of Positions : 01 Experience : 1 to 6yrs Employment Type : Full Time, Permanent Education : UG: B.Tech, BEE (Mechnical / Electrical) Compensation : As per Industry norms & experience Key Skills : PPM, Maintenance Management, SOPs, cGMP and GDP Procedures, Utility Maintenance.

1. Responsible for preparation of Validation Master Plan, validation related SOPs and schedules. 2. Responsible for preparation of facility, equipment, area qualification protocols and reports. 3. Responsible for execution of facility, equipment and area qualification activities. 4. Responsible for compilation and review of validation raw data and test certificates. 5. Responsible for preparation and review of Computerized system validation (CSV) documents and execution of CSV for equipments. 6. Responsible for preparation of User Requirement Specification, Design Qualification, FAT protocols, SAT protocols, Installation qualification, Operational qualification and Performance qualification, Revalidation protocols and reports. 7. Responsible for execution of IQ, OQ, PQ, Revalidation of Equipments. 8. Responsible for In-process assurance of Engineering department activities like utilities monitoring, verification of log books, PMP records, review of Schedules and calibration records. 9. Responsible for co-ordination with user department and validation service providers for execution of qualification activities. 10. Responsible for handling and review of risk assessments, deviation, change control and incidents related to qualification activities and user department activities. 11. Responsible for preparation of Utilities Annual summary reports.

Therapy expertise: Antidiabetics, preferably modern non-insulin antidiabeticdrugs like DPP4i, GLP1-RAs, SGLT2i etc. Key Responsibilities: 1. Brand Execution Market Adaptation Assist in implementing brand positioning and messaging for the Cardiac therapy portfolio, aligning with global guidelines. Conduct market research to understand therapy trends and competitive landscape. Adapt global marketing strategies for local markets while ensuring compliance and accuracy. 2. Promotional Campaign Development Support the creation of marketing collaterals such as brochures, flyers, digital assets, and promotional materials. Coordinate with creative teams to develop high-quality campaigns. Assist in executing HCP and patient communication strategies to drive awareness and adoption. 3. Business Region Support Training Work closely with regional marketing sales teams to support local execution of marketing plans. Assist in developing product training decks in collaboration with the medical team. Gather market insights and customer feedback to refine marketing approaches. 5. Cross-Functional Coordination Collaborate with Creative, Medical, and Regulatory teams to ensure seamless execution of marketing initiatives. Support new product launches and assist in lifecycle management activities. Align with regional and country-level teams to execute international marketing efforts effectively. 6. New Launch Responsibilities Support execution of launch campaigns, assist in sales team enablement,coordinate HCP engagement, adapt marketing materials gather marketfeedback for evolving Antidiabetic Therapies.

We are looking for a skilled Kneat CSV Professional with 6-12 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in Recruitment / Staffing and excellent skills in Kneat CSV. Roles and Responsibility Manage and implement Kneat CSV solutions for clients. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain technical documentation for Kneat CSV projects. Provide training and support to clients on Kneat CSV tools and features. Troubleshoot and resolve issues related to Kneat CSV implementation. Analyze and optimize client data processing workflows using Kneat CSV. Job Requirements Strong knowledge of Kneat CSV principles and practices. Experience working with large datasets and complex data processing systems. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Strong problem-solving and analytical skills. Familiarity with industry-standard data integration tools and technologies.

Roles and Responsibilities Conduct HVAC qualification activities, including cleaning, testing, and validation of equipment. Perform area validation and cleanroom validation to ensure compliance with regulatory requirements. Ensure proper documentation of all validation protocols, reports, and results. Collaborate with cross-functional teams to identify and resolve issues related to HVAC systems. Maintain accurate records of maintenance schedules, repairs, and inspections. Desired Candidate Profile 1-5 years of experience in HVAC qualification or a related field (e.g., mechanical engineering). Diploma or B.Tech/B.E. degree in Mechanical Engineering or equivalent. Strong understanding of commitining processes for cleanrooms and controlled environments. Proficiency in performing area validations, cleanroom validations, equipment qualifications. HVAC/Cleanroom Validation with hands-on in Velocity, Filter Integrity, NUPC, Recovery, Air Flow, and Temp-RH Mapping tests. Prior experience in executing area qualification (velocity, recovery, airflow) is mandatory.

Role & responsibilities Responsible for defining QA strategy, approach and execution in the field of document control, IPQA, qualification/validation, GLP, training activities etc. and responsible for leading and directing QA team To approve SMF, VMP, quality manual and validation protocol. To conduct internal audit / self-inspection to ensure compliance to GMP and another regulatory requirement. To arrange management review meeting and escalate the outcome of quarterly report to management. To handle the Market Complaints and to participate in Product Recall. To approve quality system documents likes Change controls proposals, Deviations, Incident reports, CAPA reports, OOS and OOT, NCR, Market Complaints, product recalls and Returned goods. Responsible for review and approval of new as well as revised related Specification, Standard Test Procedure and Analytical Work Record. Responsible to design validation/ qualification strategies Responsible for validation /qualification of processing equipments, cleaning equipments and testing equipments on time. Responsible for day-to-day validation planning and execution activity. Responsible to approve specifications, standard test procedures and analytical work records. 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. Responsible for regulatory & customer audits preparation, execution and its compliance. To approve and authorize technical agreements from customer and outside party. 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. To ensure the implementation of quality risk management procedures. Responsible to finalize training topics as per requirement and organize annual training plan with Training coordinator on cGMP and technical aspects. To ensure that processes needed for the Quality Management System are established, implemented and maintained. Responsible for investigation & review of non-conforming events including customer complaints and internal non-conforming events. Responsible for report, review, evaluation and tracking of change control, deviation, incident, market complaint, non-conformance report, product recall, corrective and preventive action. Responsible to ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of Quality Management System. Responsible to perform vendor audits and internal audits. To check audit trial and back-up verification documents. Participation in study raised through Quality Management System.

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.,

Job Title: GLP-Quality Assurance Personnel Location: Bangalore, KA, IN, 560099 Syngene International Limited, Bengaluru is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is a top priority, with a focus on ensuring safety guidelines, procedures, and SOPs are followed diligently. As a GLP-Quality Assurance Personnel at Syngene, you will play a crucial role in aligning laboratory practices with Good Laboratory Practice (GLP) guidelines to maintain the integrity and reliability of non-clinical safety and clinical studies. You will also work in a regulatory environment to ensure compliance with national and international standards set by organizations such as OECD, FDA, ICH, and ISO. Key Responsibilities: - Ensure compliance with OECD principles of GLP, ICH, and WHO-GCLP - Handle inspections and audits - Manage QMS activities including change controls, deviations, and CAPA - Review SOPs, study plans, and documentation related to QAU - Conduct inspections of studies, facilities, and processes in analytical and bioanalytical domains - Audit raw and electronic study data and reports - Review equipment and computerized system qualifications as per OECD Principles 17 and 21 CFR Part 11 Requirements: - Experience: 6-9 years - Knowledge of GLP principles as per OECD, ICH, FDA, and EPA guidelines - Proficiency in handling QMS activities - Ability to review SOPs and study plans for regulatory compliance - Understanding of data integrity policies and standards - Skilled in conducting inspections and audits - Competent in preparing and reviewing QAU documentation and SOPs Skills and Qualifications: - Master's degree in Pharmacology, Chemistry, or related field - Proficiency in handling multiple software applications and tools - Strong problem-solving skills with a scientific mindset - Ability to work collaboratively in a team environment - Excellent communication skills Syngene Values: - Excellence - Integrity - Professionalism Syngene is an equal opportunity employer dedicated to providing a safe and inclusive work environment for all employees.,

The role we are offering is for a Block Head to lead a key production block within our injectable manufacturing facility. Your responsibilities will include overseeing end-to-end manufacturing operations, managing a team of production staff, driving process optimization, ensuring regulatory audit readiness, maintaining compliance with cGMP standards, implementing changes, overseeing equipment and maintenance, coordinating cross-functionally, and managing inventory and resources. You should have a degree in Pharmacy, Engineering, or a related field, along with proven experience in sterile/injectable manufacturing. Strong leadership and team management skills are required, as well as knowledge of regulatory guidelines such as USFDA and EU standards. Hands-on experience with production equipment, QMS systems, and shop floor excellence tools is also desired. If you are ready to take on the challenge of leading a production block in a fast-paced, quality-driven environment, we are excited to hear from you.,

JD: -Knowledge of rotating & static equipment maintenance. - Knowledge of Gas fire boiler & coal fire boiler (8 Ton) - Knowledge of brine plant chilling, reciprocating Kirlosker make & Refrigerant ammonia. - Knowledge of Air compressor, Nitrogen plant, cooling tower, DM Plant, softner plant. - Equipment qualification & documentation. - Manpower Handling. - Shutdown planning & scheduling & BOQ preparation.

Detailed job description - Skill Set: Technically strong hands-on Self-driven Good client communication skills Able to work independently and good team player Flexible to work in PST hour(overlap for some hours) Past development experience for Cisco client is preferred.

Witnessing of manufacturing processes for sterile drug products including cleaning, sanitization, environmental monitoring and personnel monitoring to ensure compliance with CGMP regulations and regulatory standards Oversight of cleanroom behavior, contamination control and aseptic techniques To report any observations to site operations and quality and ensure compliance to the observations Review of media fill protocol and reports and witnessing aseptic process simulations Review of batch documentation to ensure product quality, regulatory compliance and meeting ALCOA++ requirements Review of environmental monitoring reports Review of unplanned deviations and CAPA

Witnessing of manufacturing process (mixing, granulation, blending, compression, coating, capsule filling) & packing (primary/secondary packaging) for solid oral products to ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory expectations. Oversight of line clearance, equipment and area cleanliness, material verification, and adherence to SOPs. Ensure compliance with data integrity (ALCOA++) standards in all documentation and records related to production and QA oversight. Review of batch documentation to ensure product quality and regulatory compliance. Review of unplanned deviations and CAPA. Review of environmental monitoring data Collaborate with site operations and quality functions to report and ensure resolution of non-conformances or compliance gaps.