161 Deviation Jobs - Page 2

As a QA Executive, you will be responsible for various quality assurance tasks including Change Control, Deviation, Out of Specification, Market Complaint, Corrective and Preventive Action (CAPA), and Annual Product Quality Review. Additionally, you will be involved in Audit Compliance Report Preparation, Label compliance, Legal Metrology (Packaged Commodities), FSSAIs Labelling and Display Regulations, and implementation of GMP/GHP requirements in the food industry. You will be required to manage Calibration activities both internally and externally, Equipment Qualification & Documentation control, Process Validation Protocol & Report Preparation, and Cleaning Validation Protocol & Report Preparation. Monitoring and compliance of Self-Inspection and Quality Audits, Technology Transfer activities, HACCP preparation and monitoring, QMS activities, Food safety-related activities, and training execution will also be part of your responsibilities. Furthermore, you will oversee the checking of Building and Facility, Equipment, HVAC System, and Process Validation. Managing GMP and Quality Documents, including CQPs & SOP's, Protocol and Reports, Formats, Logs and Log Books, and Batch Record will also be part of your duties. In this role, you will also monitor and review Reprocess and Recovery in manufacturing areas, ensure GMP Compliance in the plant on a daily basis, and coordinate with various stakeholders to maintain quality standards. This is a full-time position with benefits such as health insurance. The work schedule is during the day shift. The ideal candidate should have at least 2 years of experience in QA/QC, Quality assurance, Quality management, CGMP, Food safety, Food industry, and HACCP. Please note that the work location for this position is in person.,

You are invited to a Walk-In Interview at Zydus Corporate Park in Ahmedabad on Saturday, 28th June 2025, from 10:00 AM to 03:30 PM. Zydus is a global healthcare provider focused on innovation and committed to enhancing healthcare therapies to create healthier communities worldwide. ### SAP S/4 HANA Opportunities: 1. **SAP FICO Consultant:** - **Experience:** Minimum 5 years in SAP FI, FM, PS, CO, and S/4HANA. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Responsible for designing and implementing SAP FI/FM solutions, integrating with MM, SD, and PPQM modules, and driving process improvements. 2. **SAP ABAP Developer:** - **Experience:** Minimum 5 years in OOABAP, SmartForms, IDocs, and SAP HANA. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Design, develop, and optimize ABAP programs supporting SAP applications. 3. **SAP MM/WM Consultant:** - **Experience:** 5 - 8 years with S/4HANA, knowledge of warehouse management is advantageous. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Drive SAP MM implementations and integrations with SD, PP, QM, WM, and FI modules. 4. **SAP BW Consultant:** - **Experience:** 5 years. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Expertise in SAP BW and BO, strong development and maintenance skills, knowledge about SAP Process, and excellent communication skills. ### Microsoft Technology Opportunities: 1. **Full Stack Developer (Dotnet + Angular):** - **Experience:** 5-7 years with Azure DevOps, AKS, and Microsoft SQL Server. - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Design and develop scalable solutions using .NET Core, Angular, and MS SQL. 2. **Dotnet Developer / ASP.NET Developer:** - **Experience:** 5-8 years with .NET Framework, IIS, WCF, and MS SQL Server. - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Design and develop robust solutions using ASP.NET WebForms, MVC, and Core technologies. 3. **Sharepoint Developer:** - **Experience:** 6-12 years with Office 365, remote event receivers, and SharePoint migrations (2010-2016). - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Design and develop solutions using SharePoint Online, SPFx, React, PowerApps, and Power Automate. ### Infrastructure & Compliance: 1. **IT CSV (Computer System Validation):** - **Experience:** 3-5 years. - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Role involves 24x7 user access management, maintaining Privilege and User Access Matrices, handling IT QMS activities, supporting software assessments, network maintenance, conducting risk-based failure tests, and representing IT processes during audits and regulatory inspections. This walk-in interview is for experienced professionals. Freshers are encouraged to apply online for future opportunities. Priority will be given to candidates who can join immediately and are willing to relocate to the job location. For more information about Zydus, visit [Zydus Website](https://www.zyduslife.com/zyduslife/).,

Roles and Responsibilities Prepare BOQs, estimate quantities, and monitor progress against plans. Coordinate with site teams to ensure timely completion of civil works. Conduct rate analysis, prepare bills for subcontractors and contractors, and manage vendor payments. Review drawings, check technical specifications, and verify compliance with project requirements. Oversee industrial construction projects from planning to execution.

Overall handling of Quality Procedures & Quality Management System (QMS). Handling & Issuance of NCs, CAPA and Change Control. ISO Audits, PDI, BMR, Audit Documentation, Customer Audits Required Candidate profile BE/ Btech/ Diploma- Mechanical Engineering, Min. 1 year exp as Quality Executive/ Engineer in Medical Devices or Automotive Industry. Prior exp of handling Quality Procedures & QMS, CAPA, Audits.

Performing audits of all Dr. Reddy’s Laboratories manufacturing, packing, testing, development centers and distribution warehouses as per the audit schedule. Primarily performing internal audits of CTO, FTO and R&D Sites. Performing GAP assessment of the new/revised regulatory guidance documents, USFDA warning letters / form 483s to evaluate the current approved documents for compliance / improvements or requirement of new procedures and harmonizing and implementing the best practices across sites. Review of audit responses and tracking the CAPA generated out of internal audits, regulatory audits, customer audits, cross-applicable CAPAs through OCMS, Warning letters & 483 forms gap assessment of all sites for timely and effective implementation. Performing on site verification or review of the documented evidence for compliance of previous audit observations. Preparation and review of harmonized Standard Operating Procedures and Guidance documents which shall be implemented at Global, FTOs, CTOs business units and related supporting functions. Assessing the impact on the procedures during implementation of changes in IT applications. Overview harmonization of CSV/IT compliance practices across Dr Reddy’s sites. Ensuring timely assessment and implementation of pharmacopeia and regulatory guidance updates w.r.t. CSV/IT compliance procedures across Dr Reddy’s sites. Ensuring review and implementation of simplification procedure for different CSV/IT compliance procedures across Dr Reddy’s sites to reduce redundancy. Tracking and revision of SOPs identified during SuCCEED drive and Re-Imagine QMS. Conducting training sessions for the approved documents before implementation of the procedure. Preparation of questionnaire for SOP in order to evaluate the effectiveness of training imparted. Initiation and review of quality notifications raised for revision, preparation of documents as per identified requirements. Timely communication to stakeholders about revision/implementation of SOPs. Providing data for monthly report. Providing support to sites during regulatory audits for review of systems / documents. Any work assigned by the Lead and Head of the Department Qualification M.Sc (Chemistry) with 15+ years of Pharma experience in IT/CSV quality Additional Information 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. he 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. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s 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. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com

As a Shift Operation Engineer, your responsibilities will include handling the shift operation and completing related documentation as required by SOP. You will be responsible for achieving targeted production, ensuring smooth, efficient, uninterrupted, and trouble-free operation and maintenance of the water plant, HVAC, and other utility equipment as per SOPs. Implementing best practices to comply with quality, safety, and regulatory requirements will be crucial in this role. Your tasks will also involve preparing, ensuring, and monitoring compliance of SOPs and related documentation of the engineering department. Initiating Change controls and Deviations, CAPA in the electronic system as per the need is essential. Monitoring operation, filter cleaning, filter replacement, and preventive maintenance activity of the HVAC system as per SOP, as well as checking and reviewing utility, water system, and HVAC Log books are part of your duties. It will be important to keep awareness of operational standards such as ISO 9001, ISO 14001, ISO 45001, and 13485, as well as following the regulations of various agencies like USFDA, EU, TGA, MHRA, ANVISA, WHO, Schedule M, etc. You will participate in qualification & requalification of machine/equipment and provide functional support for qualification, validation, and calibration activity. Active participation in DMS, OE, and EHS activities, as well as engagement in the process, will be required. Executing preventive maintenance plans of the respective area and ensuring good documentation and record-keeping are key tasks. Ensuring compliance of service floor activity and smooth operation and maintenance of utilities to provide uninterrupted services are also part of your responsibilities. Allocating jobs to workmen, supervising work for quality, and timely completion, as well as identifying repeated breakdowns and planning corrective actions to avoid recurrence with the engineering manager, will be important. Providing guidance and support to executives and workmen and imparting induction activity to all new joiners are also expected duties. Overall, your role will involve ensuring the proper working of HVAC systems & air conditioning units to maintain operational efficiency.,

Role & responsibilities Leads and optimizes QA function that supports organizations QMS in compliance with respective international regulatory requirements. • Hosting and support in external/client audits and regulatory inspections hosted by Auriga. • Audits and inspection handling. • Conduct internal system and process audits within Auriga systems. • Conduct external audits including the audit of vendors, clients and/or clients business partners and service providers. • Lead and manage a team of clinical audit professionals, providing guidance, training, and mentorship. • Support the operations team for adequate root cause identification, conducting gap analysis and implementation of corrective action plan. • Participate in risk assessments and preparation of risk-based audit plan for auditing internal processes, vendors and customers. • Supporting the CAPA management in audit and Inspection related CAPAs. • Support the document life cycle management, deviation handling process and change control process. • Prepare audit reports to communicate outcomes of quality review activities. • Preparation and or/review of company standard operating procedures (SOPs) and such other quality documents. • Interpret and implement quality assurance standards within the organization. • Liaise with quality representatives, internal customers and external customers across Auriga global access offices as required to achieve quality objectives. • Ensure development and maintenance of a PV Quality System for Standard Operating Procedures, auditing, review CAPAs, Change control and deviations. • Evaluate client audit and regulatory inspection findings and prepare and distributes reports to observation staff, management and customers.

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.

About: Sahajanand Medical Division Medical division is approved by state and central licensing authorities and it delivers efficient performance to meet specific requirements. The SLTL brand stents embody that bold spirit, offering a unique blend of our leading-edge technologies and time-tested engineering With Technical Collaboration & Patent Design, the company started indigenous manufacturing of Coronary products, in 2009. The company has a dedicated in-house R&D department approved by DSIR (Department of Scientific and Industrial Research). We believe that every product we make should stand for something. Something more than expected. And thats why we dont manufacture products for stereotypes. We build them for you. Kindly go through our websites mentioned below for further details. Website: www.sltlmedical.com Roles & Responsibility: Handling QA - QMS activities Change Control Deviation Non-conformity documents Line clearance activities Document Issuance Work as an Internal Auditor Skill/Knowledge Required: Graduate / Post Graduate in Science, Pharma, Biomedical 0 to 3 Years work experience in Quality Assurance role. Preferred from Medical Device industry / Pharma Industry Preferred Local Candidate. Interested one can share resume on placement@sltl.com / Whatsapp - 7490055612

Greetings from HCL! Currently Hiring for "Compliance" JD: Stakeholder Management Excellent Oral and Written communication. Extensive experience in directly working with customers Periodic Review Hands on experience in conducting Application Periodic Reviews Manage Periodic review processes including scheduling, conducting and reporting of Periodic reviews Documenting process gaps and working with stakeholders to rectify them Experience in analyzing risks and working with stakeholders for mitigations Deviation Performs Deviation Creator role and maintains the Deviation lifecycle and creates identified Deviations as a Deviation record in QMS system Collaborates with multiple stakeholders in recording, managing deviation Supports as required in Route Cause Analysis (RCA) process using QMS specified method to manage Deviation Ensures Deviations are linked to CAPA and Effectiveness Check Ability to communicate and manage multiple stakeholders across different spectrum CAPA Adept in using CAPA management module using TrackWise or any eQMS system Creates requests for Due Date Extension or “Cancellation” requests for CAPA as per the stakeholder request Tracks all CAPA, Deviations to closure without any timeline deviations Provides trend analysis of CAPA to identify patterns and to measure effectiveness check Proactively escalates necessary communications to ensure CAPA is timely managed Proactively communicates and excels in stakeholder management Supplier Assessments Extensive knowledge and experience in conducting supplier assessments Experience - 5-14 years Location - Bangalore / Chennai / Noida / Pune / Hyderabad Notice period - Immediate to 30 days Only CTC - Can be discussed Interested candidate please share below details along with update resume Candidate Name- contact Number- Email ID- Total Experience- Relevant Experience- Current company- Preferred location- Notice Period- Current CTC- Expected CTC- Interested candidate please drop mail to "kushmathattanda.baby@hcltech.com" Regards, Kushma kushmathattanda.baby@hcltech.com

Role & responsibilities To review that all relevant quality management systems of Hosur manufacturing site are implemented and well maintained. To review, monitor and improve Quality performance of Hosur manufacturing site. To promote quality attitude, awareness, and mindset of the site by all proper means including training to the cross functional team members. Implement, audit, and develop quality management system, in line with Global quality policy/ manual and procedures relevant to area. Ensure the required process controls are in place wherever they are necessary. To review that testing and inspection of all raw materials, packaging materials and finished goods are carried out as per documented testing procedures and specifications. To review that the release of all raw materials, packaging materials, bulk as per approved SOP before they are used for further production activities. To review the release process of all finished goods as per approved SOP and global requirements including GFS before they are released for distribution. To review all RM and PM used in manufacturing process are from approved suppliers and with the required quality before it reaches Hosur manufacturing site including COA verifications against the documented specifications. To review all the internal lab/ External labs are conducting the testing processes as per the documented procedures and specifications. Ensure appropriate investigation are carried out throughout the manufacturing site in case of any quality related issue and ensure the corrective and preventive actions are implemented to mitigate the identified root causes for the quality issue. Ensure the preparation of training calendar and adherence to the same. To support and conduct self-inspection quality audits across all the QMS areas and continuously improve the QMS implemented at site. To ensure that all audit points/recommendations highlighted in the audit reports are followed up and closed effectively as per the agreed timelines. Review the performance of suppliers on a regular basis. To support all key initiative at the site as key member of the site. To support the site in conducting management review meetings as per the schedule. To accept and execute other responsibilities assigned by the management time to time.

Handling of Document issuance, BMR / BPR issuance, Change control, deviation, Control (Retain) Sample management, SOP issuance/ Document archival and retrieval, Issuance Management of Doc Cell., Internal audit activities,

Role & responsibilities (Production): Assist in manufacturing operations of parenteral dosage forms (sterile injections) as per SOPs and GMP guidelines. Monitor and record process parameters during manufacturing and filling operations. Ensure compliance to cGMP, documentation and data integrity norms. Support continuous improvement initiatives in production efficiency and compliance. Role & responsibilities (Engineering): Assist in preventive maintenance and breakdown handling of production equipment Support engineering team in equipment qualification and calibration activities. Monitor Utility systems Maintain proper documentation as per GMP norms. Follow safety protocols and support new initiatives Preferred candidate profile Basic knowledge of sterile/aseptic manufacturing / pharma production equipment Interest in plant maintenance Willingness to work in shifts & controlled environment Good documentation and communication skills Attention to detail and compliance mindset Good observations and analytical skiils

Role & responsibilities Incharge for QMS activities, Preferred candidate profile Should have good knoledge about QMS, Validation, calibration , qualification, re-qualification, change control. CAPA, OOS, OOT & Investigation. Mainly for all Process equipments and Utility ( HVAC System, Purified System, Refrigerator System, Air Compressor System & Boiler ) Exposure with Regulatory Aduits.

Responsibilities: * Implement Change Control procedures during deviations/CAPAs. * Conduct BPR reviews, BMR analysis, GMP compliance checks. * Ensure product quality through process validation and CAPA implementation.

Responsible for the Investigation of customer complaints received from telecollections via RTS. Job Responsibility Investigation of assigned customer complaints Root cause analysis of complaints and suggest corrective actions Primary contact for all customer experience reporting and complaint handling activities This individual is responsible for independently receiving, documenting, investigating, and coordinating responses on all complaints. Ensures timely investigation of and response to all complaints. This involves initiating and participating in investigations and corrective action arising from complaints. Maintains current and complete complaint files. Performs analyses of complaints and implant reports for trends and identification of potential corrective or preventive actions

Candidate should be able to achieve the organizational goal in maintaining the Quality Management system of API industry. He should be able to execute various function QMS like CAPA, Deviation, CC, Risk assessment ETC Candidate Profile: Should have minimum Two years experience. He should be able to work with the team and be willing to take initiative & challenge for completing the task timely

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business team focusses on B2B model for EU, Canada and emerging markets. Kindly refer www.jubilantpharmova.com for more information about organization

-Check documents like packing sheets, Temp Records, Logger readings -Exp with CAPA documentation -Monitor & maintain the temperature systems -Provide training & prepare training records -Branch visit & perform self inspection activity for branches Required Candidate profile -Male/Female willing to travel (PAN INDIA) -Exp in food/pharma industry preferred -Exp in CAPA documentation is a MUST -Excellent verbal and written communication skills Perks and benefits PF, ESI, Mediclaim, Bonus, PL

The Deputy Manager - Quality Management System (QMS) is responsible for overseeing and ensuring the effective implementation, maintenance, and improvement of the Quality Management System within the PCC Digwal. The role involves meticulous management of documentation, adherence to regulatory requirements, and proactive involvement in quality-related processes. Key Responsibilities: Key Responsibilities: 1. Manage the ENSUR system for issuance and retrieval of SOPs, specifications, ATRA, worksheets, stability protocols, BMRs, BPRs, BFRs, etc., as per requirements. 2. Ensure adherence to document control procedures, including archival, retention, and destruction of documents as defined in the procedure. 3. Manage master and obsolete copies of SOPs, specifications, ATRs, worksheets, stability protocols, BMRs, BFRs, BPRs, etc. 4. Track SOPs, procedures, specifications, etc., for revision according to their validity period. 5. Responsible for archival management, including archival and retrieval of documents as required. 6. Perform login and review of quality management system documents such as change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc. 7. Track all quality management system documents till closure, including change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc. 8. Generate monthly tracking reports for quality management systems as per defined procedures. 9. Handle product quality complaints (Adverse Events) and medical inquiry reconciliation tracker for the Digwal site, coordinating with Pharmacovigilance team for adverse events as applicable. 10. Review and approve investigation reports, risk assessment reports, and ensure the implementation and effectiveness assessment of CAPAs. 11. Review quality system documents such as protocols, reports, procedures, APOR, trend analysis reports, continual process verification reports, etc., as required. 12. Share documents with the Regulatory Affairs department for filing updates based on change control implementation. 13. Prepare and review customer and external audit compliance reports. 14. Review and approve analytical reports such as batch analysis, standards, stability studies, etc. 15. Perform GMP verification and compliance review. 16. Ensure compliance with Safety, Health, and Environment (SHE) guidelines, rules, and regulations, including the usage of Personal Protective Equipment (PPE) where applicable. Qualifications: Bachelors degree in pharmacy, Chemistry, or related field. Master's degree preferred. 8-12 years of relevant experience in pharmaceutical Quality Assurance/QMS roles( API / API & Formulations ) Strong understanding of regulatory requirements and quality standards in the pharmaceutical industry. Excellent organizational, communication, and problem-solving skills. Ability to work effectively in a team and independently, with attention to detail and accuracy Skills: Proficiency in handling documentation and data management systems, particularly Harmony. Strong organizational skills with attention to detail and the ability to manage multiple priorities.

The primary responsibility of this role is to conduct market research to gain insights into the requirements for new product development. You will be tasked with identifying the needs of the company and utilizing market research to define the objectives and needs of new products. Utilizing CAD software, such as AutoCAD, SolidWorks & CATIA, you will be responsible for conceptualizing new product ideas and designing prototypes. The role also involves creating 2D and 3D drawing specifications based on the specific requirements. A good understanding of Sheet Metal material manufacturing processes like CNG, Bending, Welding, Cutting & Assembly is essential for this position. You will also need to have a grasp of design-related processes post-production, such as Deviation, ECR, ECN, etc. Fabricating prototypes for testing and troubleshooting potential issues during the design process are key aspects of the role. Additionally, you will be required to test products throughout the design process, sample different materials and manufacturing processes to determine the best options that align with the new product brief. Fine-tuning designs until they are production-ready and delivering product specifications to the manufacturing team are crucial responsibilities. Furthermore, analyzing existing products for areas of improvement, developing quality control criteria, and safety guidelines, as well as ensuring team compliance with these standards, are vital components of this role. You will also need to prepare engineering calculations, drawings, and specifications, participate in design reviews, and coordinate engineering schedules with project team members. Traveling to factories and vendors to take measurements and observe productivity processes, reviewing and approving documentation for quality and safety, and conducting cost analysis and negotiations with suppliers are also part of the job requirements. Qualifications: - BE/ BTech. /Diploma in AutoCAD, SolidWorks Mechanical Engineering - Proficiency with ERP/SAP - Experience with CAD software (AutoCAD, SolidWorks & CATIA) for 2D and 3D drawings - Experience in Manufacturing Setup - Residence near or in Greater Noida City - Proficiency in MS Office This is a full-time, permanent position with a day shift schedule and in-person work location.,

Roles and Responsibilities Maintain accurate records of all quality-related activities and reports. Conduct quality audits, internal audits, BMR review, capa, change control, GMP compliance, deviation management. Ensure adherence to cGMP guidelines during production runs. Identify areas for improvement through continuous monitoring of processes and implement corrective actions. Collaborate with cross-functional teams to resolve quality issues and improve overall productivity. Document issuance (i.e., Batch Manufacturing Record , Lab Note Book, Log books, analytical work sheets, SOP formats etc.,) Review of executed documents (e.g., Batch Manufacturing Record, analytical work sheets Equipments usage log books, area cleaning records, calibration records, preventive maintenance records, Lab Note Book,) Retrieval and archival of quality management system related documents. Preparation of annual schedules (GMP training schedule and On Job Trainings, Preventive Maintenance, Equipment calibration, Internal Audit and Management Review Meeting) and conducting according to these schedules. Initiate the change control, deviation related to quality functions. Preparation of Certificate of analysis Coordinating with External Testing Laboratories. Reviewing the completed analytical reports, Calibration reports for its compliance. Reviewing the Instrument/Equipment master Calibration schedules for its compliance. Assistance for the new analytical method development and validation as per the guidelines.

Role & responsibilities Job Description: 1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOP’s related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, and PQ for the equipment’s. 8. Writing of relevant Batch documents and log books. 9. Execution of production plan for formulation and filling. 10. Achieving planned FP targets with strict adherence to cGMP. 11. Execution of planned activities of Aseptic Processing Areas like media fills simulation trials, Formulation and filling activities. 12. Execution of preventive maintenance plan for equipment’s in coordination with Engineering and QA departments. 13. Performing day to day activities as per requirements. 14. Reporting all the activities, deviations and issues to Reporting officer. Preferred candidate profile ITI/ DIPLOMA/ B. TECH/ Pharmacy With Relevant experience

Long Description 1 Exposure of execution of planning of Inprocess, Finished product, stability and cleaning validation samples of MDI / DPI formulation. 2 Exposure of compliance to all cGMP, GxP or any other regulatory requirements, including EHS requirements. 3 Maintenance of GLP in the Laboratory. 4 Having knowledge of Analytical Instruments like HPLC, GC, GCMS, LCMS, UV, IR, KF, ACI, NGI, DUSA, Spray Pattern etc. 5 Exposure of Laboratory investigation like OOS, OOT, Incidence, Deviation, CAPA, Change control etc. 6 Exposure of Stability sample management & Regulatory Audits. 7 Exposure of Analytical method transfer, Analytical method validation / Verification activity. 8 Exposure of Calibration of Analytical Instruments & Equipment’s 9 Compliance to observation noted during internal and external audits. Competencies Strategic Agility Process Excellence Collaboration Innovation & Creativity Result Orientation Stakeholder Management Customer Centricity Developing Talent Education Graduation in Pharmacy Work Experience 10 to 15 years.

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