161 Deviation Jobs - Page 5

Receive and Log Complaints : Record and evaluate complaint submissions from customers regarding manufacturing defects or issues. Ensure all complaints are logged accurately in the complaint management system. Investigate Complaints : Conduct thorough investigations to determine the root cause of the complaint. Coordinate with internal departments (Quality Assurance, Regulatory Affairs, Production) to gather necessary information. Communicate with Stakeholders : Communicate with customers to understand their concerns and provide updates on the investigation. Liaise with healthcare providers, if applicable, to acquire relevant complaint information. Regulatory Compliance : Ensure timely processing of complaints in accordance with regulatory requirements. Generate and submit reports to appropriate authorities and government agencies as required. Corrective Actions : Recommend and implement corrective and preventive actions (CAPA) to address and prevent recurrence of issues. Monitor the effectiveness of implemented actions. Documentation and Reporting : Maintain detailed records of all complaint investigations and resolutions. Prepare trend reports and metrics to capture and analyze complaint data. Audit Preparation : Participate in activities to prepare for audits and inspections. Ensure all documentation is compliant with GMP (Good Manufacturing Practices) standards.

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Manager QC (Micro) Job Requisitions No : 13788 Job Description Purpose of Job Responsible for handling QMS, Review and Planning for QC Micro department, Skill Required Handling of Change Control, Deviation Investigation, OOS Closure, Microbial Data Deviation Investigation, Incident Management Roles and Responsibilites Responsible for review, investigation and documentation, Review of DRS, Documents and data related raw material, packing material and consumable material, reagent & volumetric and water analysis, To execute and support in investigation of LIR, OOS, OOT, OOL, NCR and Deviation To execute and support in change control Execution of gap analysis of QC system and effective implementation of cGMP and regulatory requirements Preparation, review and revision of documents as and when required To verify calibration/ verification/ qualification/ cleaning/ monitoring activities of various QC instruments/ equipments as per schedule To impart training on different tests to new employees and student trainees Responsible for general work place cleanliness, proper equipment management and adherence to all approved SOPs and GMP procedures To Review Microbiological test records like CCIT, study/validation documents, BI etc Method Validation protocol/Study preparation and execution of BET, Bioburden, Sterility, CCI, Sub Visible Particles Test Trend Preparation Handling of Incident Handling of Software like SAP, LIMS, NIV DAS etc Media Fill observation Qualification Required Sc Relevant Skills / Industry Experience Handling of Change Control, Deviation Investigation, OOS Closure, Microbial Data Deviation Investigation, Incident Management Relevant professional / Educational background Sc Any Other Requirements (If Any) Compensation / Reward Location: Biotech, Ahmedabad, GJ, IN, 382213 Travel: 0% 25% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Officer Parenteral Job Requisitions No : 13861 Job Description Purpose of Job To supervise all activities in oncology parenteral department, Visual inspection area, external vial washing and freeze dryer technical area activities, Skill Required To supervise all activities in oncology parenteral department, Visual inspection area, external vial washing and freeze dryer technical area activities, Roles and Responsibilites To ensure cGMP compliance in the department, To ensure area, equipment and line clearance and cleaning of equipment before startup of the operation, To ensure that after completion of operation line closure activity should be performed in accordance with SOPs, To ensure that deviation, change control, CAPA is generated as and when required, To maintain the area cleanliness and arrangement before and after completion of activities, To provide technical support relating to equipment utilized in the area by repairing, maintaining and modifying production equipment utilizing technical expertise, technical manuals, precision tools and test equipment, To provide the versatility training and development of the team members, To prepare the SOPs related to area and contribute to revision of SOPs, To prepare MPCR and to ensure the production operations are followed as per the MPCR, Responsible for completion of all documentation in a timely manner and to ensure that all the Equipment log, records of housekeeping,formats and MPCRs are online, Execution of qualification activities as per qualification protocol, To ensure that production is going as per predefined schedule, To co ordinate with engineering department for normal functioning of the machine in the departments Also adhere to the preventive maintenance and calibration schedules, Any other job assigned by the superiors, In absence of said employee his/her job responsibility shall be taken care by another employee working along / under /above him/her and shall be mention in job responsibility, To ensure the compliance of EHS norms in Parenteral area, To follow ?Good Documentation Practices and Data Integrityrequirements during any GxP Operation and recording at site, To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed, To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP Data (Records, Reports) Specific To Job Description, To ensure that, In case of any event of potential data breach, it shall be handled through SOP on ?Handling of Potential Data Integrity Observation, To supervise all activities in oncology parenteral department, Visual inspection area, external vial washing and freeze dryer technical area activities, Qualification Required Pharmacy with reputed co Relevant Skills / Industry Experience Should have 4 5 years of experience in sterile mfg, Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: SEZ, Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

Role & responsibilities Lead the vendor qualification process, including the evaluation and approval of new and existing vendors. Review and approve vendor documentation to ensure compliance with internal standards and regulatory requirements. Manage QMS notifications, ensuring timely resolution of issues related to change control, deviations, and CAPA. Oversee the preparation, review, and approval of SOPs to ensure alignment with current practices and regulatory standards. Conduct comprehensive risk assessments and risk analysis to identify potential quality issues and implement mitigation strategies. Independently plan, conduct, and report on vendor audits, coordinating with internal and external stakeholders to schedule and execute audits. Preferred candidate profile Bachelors or Masters degree in Pharmacy from a reputed institution. Should have 10 -15 years in corporate quality assurance roles within the pharmaceutical, biotechnology, or related industries. Should be proficient in quality management software such as Trackwise, Caliber, SAP, TMS, DMS, and QAMS. Should have experience in vendor qualification management, vendor documentation and managing vendor audits.

Job Role: Overall responsibility of quality assurance & food safety for Snacks category (includes Potato Chips, Extruded & Fried Snacks, Traditional namkeens, Sweets and similar products) manufactured at third-party locations and/or RCPL sites, successful implementation of RCPL quality systems, setting up monitoring & testing protocol for various quality parameters, third-party mfg. locations audits, training and driving quality culture. Key Responsibilities: 1. Compliance with RCPL Quality Standards: • Develop & communicate RCPL Quality Standards & Technical-manuals for SNACKS category • Implement & maintain RCPL quality standards & processes at 3P locations • Ensure incoming RM/PM or ingredients in compliance with RRL specifications & correct test methods are used by site team • Ensure process specifications are met and in compliance with RCPL specs • Ensure FG specifications are met and in compliance with RCPL specs (e.g. pack weights as per W&M rules, batch coding, seal integrity, sensory of products etc.). Verify production for the late-night shifts before dispatched to market • Timely communication of any deviations of specs for RM, PM., Processes, FG to TCM, Site team and RCPL category leads. Follow through for immediate closures and updates • Ensure FG & water are tested from an accredited lab as required by regulators • Ensure HACCP SOPs are successfully implemented and followed for 3P sites • Ensure basic GMPs/HK practices are followed by site team and follow up for corrections for observed gaps with site team • Ensure daily/monthly/quarterly GMP/HK/Pest control etc. checks or audits are conducted by site team and support them for conducting inspections. Follow through with site team for gaps closures • Ensure or provide necessary food safety/GMP/process/lab training etc. to the site team on periodic basis and/or follow through with site team for any required external training needs • Conduct periodic audits of 3P sites against RCPL quality standards and/or HACCP or FSSC 22000 procedures. Key Competencies required: 1. Functional Competencies: a. SME on Snacks processing- Potato Chips, Namkeen & Sweets (experience preferred) b. Technical excellence c. HACCP & risk assessment for Snacks category d. Audits (suppliers and mfg. locations) e. Snacks projects (preferred) f. Specification management g. Process management h. Complaints handling i. Driving Snacks productivity (preferred) j. Knowledge on Regulatory compliance 2. Behavioral Competencies: a. Action oriented b. Drive for results c. People/team management d. Networking & effective stakeholders management e. Problem solving f. Coaching & training the teams

Job Description 1. Preparation of SOPs of QA, review of other departments' SOPs, 2. To perform batch release of API material and review of related documents. 3. To prepare and review Quality Risk Assessment, Site Master File, Hold Time Study Protocol/Reports, and other study protocols/reports, Specifications, Stability Protocol, and Stability Report Data. 4. Review of Validation Master Plan. 5. To review the analytical method transfer protocol/report and method validation documents of the API. 6. To ensure and handle the investigation of out-of-specification Results, OOT, Deviations, Product failures, and Market Complaints. 7. To review Quality system documents such as Deviation, Change control, CAPA, OOS, OOT, re-processing, Re-work, market complaints, and market returns. 8. To review Qualification Protocols/Reports of product, equipment, and facility. 9. To Review of the Annual Product Quality Review. 10. To review of Master Document, such as BPR, Test and Calibration Data Sheet, Test Procedures, and Microbiological Test Procedures. 11. To collect, review, and submit documents to the RA Department for dossier preparation /Regulatory Submission. Work Experience 5 to 8 Years Education Post Graduation in Chemistry Competencies

Position Assistant Manager-QA Function QA Location Bharuch;;;;;;; Reports to Head QA Summary of Job (Purpose/ objective of the job Department organogram to be enclosed) To check the Quality Assurance of the products and ensure compliance with the SOP's. Key Responsibilities (Performance Indicators) Quality professional of progressive experience with strong knowledge of Speciality Ingredient, Bulk Chemicals, Food additive/ Food supplement and API Manufacturing, Quality Management System (QMS), Qualification, Validation and other Manufacturing functions.; Documentation and Handling i.e.: Integrated Management System (IMS) (ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018), WHO-GMP, FSMS (ISO 22000), FAMI-QS, Energy Management System (EnMS), Halal, Kosher and Responsible Care and regulatory (FDCA, USFDA, MHRA).; Expertise in change control, deviation, market complaint, non-conformance investigation, vendor audit, self-inspection, gap assessment, customer audit, training, vendor management, vendor questionnaire, validation, equipment and utility system qualification. Issuance and retrieval of Batch Manufacturing Records. Control and Issuance of formats. Ensure that retention of various documents, reports and records are as per documented procedures. Issue copy of Master Batch Production Instructions to production for batch manufacture and review critical control parameters before release of the batch. No. of Reportees NA Qualification and Experience M.Sc Organic Chemistry with 3-6 yrs Key; Competencies ( Technical, Functional and Behavioral) Integrated Management System (IMS) (ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018), WHO-GMP, FSMS (ISO 22000), FAMI-QS, Energy Management System (EnMS), Halal, Kosher and Responsible Care and regulatory (FDCA, USFDA, MHRA). Knowledge of validation process. Practical experience in documentation as per various audits. Approval VP - Mfg Unit HR

"Key responsibilities: Perform analysis, report raw data, ensure data tracing, submit reports, address reviewer comments, follow GLP, report incidents/deviations, review data accuracy, provide training, and handle events as per SOP."

1. Quality Management Systems: Implementing, monitoring, and maintaining Quality Management Systems to ensure compliance with CGMP/regulatory guidelines. 2. Documentation: Reviewing and approving technical and quality documents. Required Candidate profile Should be minimum Post Graduation in Science having the work experience of about 6-7 years of experienced in FMCG company or in pharma industry.

Developing and Implementing QA Systems and Procedures: Responsible for establishing and maintaining quality assurance systems, policies, and procedures. This includes creating SOPs (Standard Operating Procedures), work instructions. Required Candidate profile Strong knowledge of cGMP and relevant regulatory requirements: This includes understanding manufacturing processes, quality control procedures, and validation requirements.

Job Description Labware 7. LIMS implementation, Master data creation, Validation. Caluculation configurations. CSV documentations, Test Script review, Instrument integrations. LIMS trouble shooting and resolutions. QAMS activities, CCP, CAPA, Deviation investigation. Work Experience 4-7 years of experience in QC and LIMS Implementation Education Post Graduation in Analytical Chemistry or Analytical Chemistry Graduation in Pharmacy or Pharmacy Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.

Job Description Officer/Executive- Packaging & Development 1. Design, preparation, review and approval of documents - OPMLs, BPRs, Specifications for Packaging materials, In-house Labels and Pallet Matrix. Checking of Artworks and Shade Cards for labels, Primary & Secondary packing materials. 2. Execution and coordination for SAP related activities like loading of master recipes and Bill of Materials (BOMs) for Finished Goods (FGs). 3. Conducting different Trials for Packing Materials, 4. Monitoring and technical support for execution of Packing equipment qualification/ Trial / Scale up / exhibit / commercial process validation batches on packing lines and handling of investigations, if any during the execution. 5. Handling of Deviations, Change Control, CAPA and Document Record Management. 6. To support site regulatory affairs in timely filings of exhibit products and to assist plant in regulatory inspection of customers and regulatory agencies. 7. Preparation of packaging material specifications base document. 8. Transportation study protocol/report preparation and execution of transportation study. Work Experience 2 to 5 years Education Graduation in Packaging Technology or Pharmacy Competencies Customer Centricity Developing Talent Collaboration Strategic Agility Process Excellence Stakeholder Management Innovation & Creativity Result Orientation

JOB DESCRIPTION (JD) Designation: Executive/Senior Executive Location: Gurugram Department Name: R&D Quality-CMC QA List of Responsibilities / Job Functions: Review of R&D documents such as stability data, Analytical reports, Method Qualification reports, Method verification reports, Method validation protocols & reports, Working Standard / Impurity Standard profile, analytical data of pilot bio batches and Method transfers protocol & report. Review of Lab event/Deviations/Change control/CAPA and associated investigation reports prior to Technology Transfer. Support and participate in f ailure investigations and resolution of root causes for issues related to systems and products developed within Sun Pharmaceutical Industries Limited R&D sites. Visiting the AD Labs / Areas for verification of GDP & GMP compliance. Audit of Analytical Development department. Ensure the periodic activities as per the quality procedures are performed in a timely manner. Work in partnership with the site cross functions and corporate functions for Audit readiness. Lead the assessment, tracking of remediation and monitoring of identified actions as part of various corporate initiatives. Perform other duties as assigned by Functional Head time to time. Review and approve the periodic activities as per the quality procedures. Support operations team during corporate audit/ external audits Lead the assessment, tracking of remediation and monitoring of identified actions as part of various corporate initiatives. Review of Product development data and specification.

Chemveda is hiring for Quality Assurance Executive Position Experience - 2-6 years Qualification - M.Sc Chemistry /M.Pharma Designation - Executive Job Responsibilities :- 1. Involves in daily QA activities for SOP compliance. 2. Equipment and Software qualifications Review of USR & SRS, Review of IQ, OQ, PQ document inhouse softwares and maintenance of Equipment and software related back up coordination with other departments. 3. Preparation of refresh and QMS Training presentation and circulating training links to all employees based on training schedules and follow ups. 4. Review of Risk assessments related to change control, CAPA, Deviation, OOS, OOT. 5. Review of Analyst Qualifications and review of Analytical LNBs. 6. Review of Vendor Questionnaires and Review of Vendor qualification documents and checking external facility and vendor audits with respect to raw materials and finished products. 7. Review of new GMP projects with regard to regulatory and client compliance aspects, Scrutiny of GMP facilities and Review of GMP Certifications & all requirements applicable to the projects. 8. Review of SOPs, Specifications, Method of Analysis and Analytical test data sheet. 9. Review of Method transfer protocols and reports, Validation protocols and reports, Forced degradation data and Review of quality impacting incidents, OOS and Data corrections. 10. Lab rounds and Compliance verification and Qualification of GMP Contract Manufacturing Facilities (CMO). a. Circulation of Non-compliances b. Circulation of Non-Compliance reports to CMO 11. Circulating agenda for Internal Audits and Management review meetings, Reporting & Circulation of Non-Compliances and Suggestion of appropriate CAPAs. 12. Functional Objectives: Follow-up & review of the objectives action plan and Data collection & compilation. 13. Review of weekly and monthly reports and collecting data. 14. Monitoring of QMS activities as per ISO & Client requirements. 15. Document issuance, retrieval and archival, document control. 16. During the audits, to coordinate with the with the auditors to show and explain the documentation of quality systems & procedures. 17. Preparation quality system procedures and quality manual. 18. To prepare audit compliance reports or responses and to ensuring the successful closure of audit cycle.

Role & responsibilities Key deliverables Supervise compliance of cGMP and any other applicable regulatory requirement, including EH&S requirements. Complete self-training and monitor training of team members on the relevant SOPs. Report any quality concern or suggestion for improvement to managers. Execute and supervise all tasks and activities as per the applicable SOPs. To lead and guide site investigation teams to investigate the reported OOS, repeat OOT, deviations and market complaints by working closely with site CFT and operating personnel, to arrive at appropriate RCA and CAPA. To personally lead major/critical/repeat investigations and ensure proper closures. To review and share weekly / monthly report of investigation with focus on key findings, repeats, open issues, CAPA effectiveness, learnings etc. , to the management. To analyze historical data of investigations periodically, to derive trends emerging on any findings or any quality concerns or improvements and notify the management. To review and improve quality of investigations of other investigation members in terms of technical report writing skills as per format. To conduct training programs on technical/ GMP related topics and ensure trainings of subordinates / team members. To participate and support in Investigation management formats, matrices design and implementation. To provide support to site during regulatory inspection or audits / Inspections conducted by local regulatory bodies / vendors / third parties, for related investigation. To support the Quality Management Systems document closure - Deviations, OOS, OOT, LIR and market complaints, change control and CAPA, ensure upkeep of documents related to investigations and ensure compliance in QAMS as per requirement. To perform any additional activity related to investigation as and when required. Key customers Preferred candidate profile Education: B. Pharm / M/Pharm Competencies Education Work Experience 10 to 15 Years Perks and benefits As per standard norms

Chemveda is hiring for Quality Assurance Executive Position Experience - 2-6 years Qualification - M.Sc Chemistry /M.Pharma Designation - Executive Job Responsibilities :- 1. Involves in daily QA activities for SOP compliance. 2. Equipment and Software qualifications Review of USR & SRS, Review of IQ, OQ, PQ document inhouse softwares and maintenance of Equipment and software related back up coordination with other departments. 3. Preparation of refresh and QMS Training presentation and circulating training links to all employees based on training schedules and follow ups. 4. Review of Risk assessments related to change control, CAPA, Deviation, OOS, OOT. 5. Review of Analyst Qualifications and review of Analytical LNBs. 6. Review of Vendor Questionnaires and Review of Vendor qualification documents and checking external facility and vendor audits with respect to raw materials and finished products. 7. Review of new GMP projects with regard to regulatory and client compliance aspects, Scrutiny of GMP facilities and Review of GMP Certifications & all requirements applicable to the projects. 8. Review of SOPs, Specifications, Method of Analysis and Analytical test data sheet. 9. Review of Method transfer protocols and reports, Validation protocols and reports, Forced degradation data and Review of quality impacting incidents, OOS and Data corrections. 10. Lab rounds and Compliance verification and Qualification of GMP Contract Manufacturing Facilities (CMO). a. Circulation of Non-compliances b. Circulation of Non-Compliance reports to CMO 11. Circulating agenda for Internal Audits and Management review meetings, Reporting & Circulation of Non-Compliances and Suggestion of appropriate CAPAs. 12. Functional Objectives: Follow-up & review of the objectives action plan and Data collection & compilation. 13. Review of weekly and monthly reports and collecting data. 14. Monitoring of QMS activities as per ISO & Client requirements. 15. Document issuance, retrieval and archival, document control. 16. During the audits, to coordinate with the with the auditors to show and explain the documentation of quality systems & procedures. 17. Preparation quality system procedures and quality manual. 18. To prepare audit compliance reports or responses and to ensuring the successful closure of audit cycle.

Sr. Executive AM- Hot Refining: CMR GreenTechnologies Limited CMR Group is India's largest producer ofAluminium and zinc die-casting alloys. With 13 state-of-the-art manufacturingplants across the country, CMR has become the preferred supplier for many ofIndias largest automotive industry leaders. Since its inception in 2006, CMRhas consistently outpaced competition by focusing on delivering superior valueto its stakeholders. This value is driven by a strong commitment to technicaladvancements, quality enhancement, sustainability, and people-centric practices.We believe in an " Employee First " philosophy, ensuring that our people are at the core of our success. Our dedication tofostering an enriching work environment is reflected in our recognition asthe 'Most Preferred Place for Women to Work' and as one ofthe Top 25 Mid-Sized Indias Best Workplaces in Manufacturing for 2025 by GreatPlace to Work. As CMRcontinues to chart its growth trajectory, we remain committed to innovation andexcellence. We are always looking for enthusiastic and dynamic individuals tojoin our team and contribute to our continued success. Position : FLO- Hot Refining Location: Tirupati , Vallam , Orissa Job Band : A Designation : Sr.Executive/AM. No.of Posts : 2 Reporting to : Area Head - Hot Refining Qualification: Essential Candidateshould have full time degree or Diploma in Mechanical / Electrical / Metallurgyor a related field form any reputed institution. Desirable Degree/Diploma/Certification Course in Operation / General Management. Experience: Essential 3 to 5 years ofexperience in a hot refining or similar role within the refining ormanufacturing industry. Desired Strongunderstanding of refining processes and technology. Experiencewith process optimization and quality control in a refining environment. Excellentproblem-solving skills and the ability to troubleshoot complex technicalissues. Knowledgeof industry standards for refinery operations. Job Profile: Responsiblefor ensuring minimal deviation from " Process Monitoring Sheet " Overseehot refining operations of operators such as - Charging schedule, Fluxquantity, Alloying composition and addition of virgin alloy material etc.across Furnaces. Ensuresshift cost control, production, melt loss, dross production, recovery andquality targets Responsiblefor Quality report sign of basis spectrometry and visual checks, as well as ERPbooking Respondsto issue escalations during shift Coordinateswith maintenance to ensure availability of machine/equipments and smoothoperations during the shift Controlcorrection Ingotquality control and also control weight variation of ingots. Controlplant pollution Followall process parameter during process. CoreCompetencies: Qualitystandards Effectivecommunication Knowledgesharing and learning. ResultOriented. PreferredSkill :- Experiencewith implementing new technologies in a refinery setting. Knowledgeof environmental regulations and sustainability practices in refining. General Age-27- 30 years. CTC 3LPA to 6.5 LPA approx. Candidateshould not be frequent job changer. NoticePeriod- Joining period Max 30 Days. We can buy notice period, if required Location: Vallam: G 108/2, SIPCOT Industrial Park, Vallam Vadagal, Kanchipuram District, Vallam, Tamil Nadu 631604 Tirupati: Survey No. 429-434, APIIC Industrial Park, Chinthalapalem Village, Yerpedu Mandal, Tirupati District, Andhra Pradesh 517619 Orissa: Plant Survey No. - 2020-2027, 1991-1993, Village Derba, Tehsil Rengali, Dt. Sambalpur, Odisha 768212

Bachelor's degree with over 10 years of experience in designing and developing solutions in Trackwise. Experience working in a GMP environment, 7+ years in an IT Systems Role. Expert knowledge of GMP Quality Management to include CAPA/Deviation, Lab Exception, Product Complaint, Audit, and Supplier Management. SDLC/GAMP, Business Analysis, and Enterprise Systems Management. General knowledge of GxP Quality Processes and Systems (GMP, GLP, GCP, GVP, GDP) Demonstrated experience leading teams in the implementation of Trackwise and QMS solutions, ensuring alignment with business objectives and compliance requirements. Comprehensive understanding of Quality Management processes, regulatory compliance, and industry standards. Certification in Trackwise or Equivalent Experience is required. Strong leadership skills with the ability to manage and mentor a team of analysts and developers. In-depth knowledge of Quality Management business processes within a regulated environment, including CAPA/Deviation, Lab Exception, Audit, Product Complaints, and Supplier Management Extensive knowledge of Trackwise and other QMS modules, with additional familiarity with ERP, SCM, and PLM systems. Exceptional oral and written communication skills, with the ability to conduct effective presentations, facilitate workshops, and negotiate with stakeholders. Excellent organizational and prioritization skills, capable of managing multiple projects and tasks in a dynamic environment. Proven ability to handle multiple responsibilities, including system configuration, coding, system testing, end-to-end testing, and production support. Experience in all phases of the project life cycle from analysis and design to implementation and testing, with a focus on business process improvement and optimization. Strong analytical and problem-solving skills, with the ability to translate business requirements into technical solutions. Strong team player with excellent collaboration skills, fostering a positive team environment. Strong Knowledge of SDLC, GAMP, and Computer Systems Validation in a GxP Environment

Raw Material Inspection. Like Boards, Kraft, Liner, Adhesive, Coating, Film, Etc (Sampling, Testing, Reporting & Recording) In-Process Checking (Printing & Post printing) COA (Certificate of Analysis) making. Lab Instruments Calibration Required Candidate profile Customer Specification Analysis & Comparison Against Actual. Job Traceability (Forward & Backward) Creating Job file like Artwork, KLD, shade card, approved Dummy and Inspected incoming raw materials. Perks and benefits Accommodation, PF, ESI, Bonus

To involve from start and investigate level 2 & 3 incidents, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To Involve in valid OOS and other cases as relevant, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To review level 1B incidents and give feedback for improvement. To periodically trend level 1A incidents and highlight/escalate key observations. To review any other referred reports associated with incidents/events in association with sites. To possess high level of integrity to have unbiased, independent and objective closure of incidents and maintain high level of confidentiality and have the tenacity to get to the root cause. To use Rubrics template for investigation report writing. To provide appropriate support to site in preparing for or during regulatory inspection for investigations. Qualification B Pharmacy 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/#!/

Role & responsibilities Min 5 years experience into API Pharma background Should handle the Change controls, Deviations, CAPAs of utility & HVAC systems SOP preparations, SOP revisions of utility/HVACs Should be able to handle customer & regulatory audits Having good knowledge in HVAC operations/Breakdown Should have knowledge in HVAC validations Kindly share profiles with job title on gaurangikudavkar@lupin.com

JD: 1) To be prepared document related to audit as per audit agenda. 2) Filled vendor questionnaires & prepared related documents. 3) Keeping record of key Customer. 4) To be prepared process validation protocol and report as per seniors guidance. 5) To be prepare cleaning validation protocol and report as per seniors guidance. 7) To be prepared master, controlled, uncontrolled, reference, obsolete & distribute documents as per SOPs and formats requirement. 8) To help the senior for preparation of CAPA according to audit report. 9) Issuance of Change control, OOS, deviation & other QMS formats whenever required from respective department and retained record in logbook. 10) To be prepared BPCR as per procedure. 11) To be issue BPCR to all blocks as per prerequisite. 14) To be handle change control, market complaint, deviations, CAPA. 15) To be issue documents, protocols, log book and format to all department as per prerequisite. 16) Retrieval of documents. 17) To be controlled all master documents. 18) To be prepared schedule & conduct Internal audit. 19) To be prepared APQR of all products. 20) Preparation of documents for Certification & product registrations work i.e. FDA, Halal, Kosher, Reach. etc. Review specification, test procedure and SOP's for their deficiencies according to audit points 1) To be prepared document related to audit as per audit agenda. 2) Filled vendor questionnaires & prepared related documents. 3) Keeping record of key Customer. 4) To be prepared process validation protocol and report as per senior’s guidance. 5) To be prepare cleaning validation protocol and report as per senior’s guidance. 6) To be conduct training and evaluation done as per Schedule. 7) To be prepared master, controlled, uncontrolled, reference, obsolete & distribute documents as per SOPs and formats requirement. 8) To help the senior for preparation of CAPA according to audit report. 9) Issuance of Change control, OOS, deviation & other QMS formats whenever required from respective department and retained record in logbook. 10) To be prepared BPCR as per procedure. 11) To be issue BPCR to all blocks as per prerequisite. 13) To be prepared data for monthly report as per QMS and submit to senior. 14) To be handle change control, market complaint, deviations, CAPA. 15) To be issue documents, protocols, log book and format to all department as per prerequisite. 16) Retrieval of documents. 18) To be prepared schedule & conduct Internal audit. 19) To be prepared APQR of all products.

Retrival& Issuance of documentation GDP CGMP Control Documents Dispatch verification Batch Manufacturing

Job Title: Executive / Sr. Executive / Assistant Manager / Deputy Manager Production QMS (OSD) Work Location: Naidupeta, Tirupati District, Andhra Pradesh Experience Required: 3 15 years (must be from an OSD plant) Qualification • B.Pharm / M.Pharm Key Responsibilities • Own and update Production SOPs, BMR/BPRs, logbooks, and work instructions in line with cGMP and regulatory guidelines (US FDA, MHRA, EU, WHO, etc.) • Coordinate and investigate deviations, OOS/OOT, incidents, and execute effective CAPA & change-control activities • Perform risk assessments (FMEA/RA) for new processes, equipment, and layout changes • Conduct shop-floor audits, line clearance, and data-integrity checks; ensure readiness for all internal/external audits • Review and approve batch documentation; ensure timely batch release support in coordination with QA/QC How to Apply Email your updated CV to Ganesh.janne@aurobindo.com OR share via WhatsApp: 8096888868 (Subject/Message: Application – Production QMS (OSD) – ”) Join Aurobindo Pharma and be a key driver of world-class quality systems in our OSD operations!