97 Deviation Jobs

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

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

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

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!

Greetings for day. We are having opening for the role Manager - QMS & Documentation Management in Corporate Quality Department. Department : Corporate Quality Location : Mumbai - Andheri East Qualification - B. Pharm. / M. Pharm / M. Sc. Industry Preferred : Pharmaceutical. Work Experience :12 - 18 years Corporate Experience only. Job Description : Quality Management System (QMS) Oversight: Ensure robust implementation and periodic / Retrospective review of all QMS elements including Change Control, Deviation, CAPA, Risk Management, and Quality Review. Documentation Lifecycle Management: Coordinate periodic SOP revision cycles. Ensure alignment with current practices, regulations, and audit feedback. Maintain SOP revision matrix and history. Electronic QMS/LMS Integration & Control: Develop and deliver orientation programs for new joiners covering company policies, ethics, compliance, and site-specific SOPs. Skill Requirements : Competent in extracting, organizing, and interpreting data from QMS systems for management review and trend analysis. Experience in preparing Quality Metrics, Dashboard Reports, SOP compliance trends, and identifying areas for process improvement Proficient in managing the document lifecycle, Organized approach to multi-department coordination, documentation deadlines, and QMS project execution. GMP Knowledge & Facilitation Skills: Deep understanding of cGMP/GxP concepts and strong delivery of technical training sessions . Interested candidate can share their profiles on pooja.t@encubeethicals.com

Responsibilities: Review of formulation development documents like trade dress for new product, feasibility report, justification for specification, scientific study protocol and report and pharmaceutical development report. Health insurance Provident fund

Handling, storage and retrieval of all the documents pertaining to facility on operation of the functional departments. Deploying Good Documentation Practices throughout all the functions. Allotment of reference numbers, Formatting, distribution, control, revision, retrieval and storage of all master documents. Maintaining of master list of documents. Maintaining online documentation. Issuance of Formats, LNBs & Log books to all departments. Preparation of QA&RA SOPs. Monitoring of Instruments and Equipment calibrations. To involve internal quality and regulatory compliance audits across all the functions. Handling of Training Records across all the functional departments. Monitoring for compliance across all functional departments. Providing adequate support to R&D teams to execute the required documents for regulatory submissions. Review of all quality documents which includes SOPs, Formats, Equipment/Instrument qualifications/ calibrations , drug excipient compatibility studies, API characterization, API solubility studies, Stability studies, Stress studies, Other studies, Method development reports, Specifications, STPs, MFR, method validations, Method transfers, PDR etc. Reviewing of LNBs, Raw data & Log books for data integrity issues.

1. Operations Undertake co-ordination with field people from CCR for smooth operation of the plant Measure various process parameters along with Shift In-charge. Record process parameters and plant log for the respective section, inspect specific parameters on regular basis, and perform any extra duties assigned by the Shift In-Charge Monitor the quality of the products- Raw meal, Clinker and Cement- and maintain the quality within the range as defined in the QMS procedures Keep good co-ordination with the laboratory for the feedback of quality follow the non-conformity procedure in case the product is not conforming to the standards Executes, according to the safety procedures, the necessary precautions and lock-outs. Take readings of plant parameters (tour log), energy and gas, and perform basic chemical water analysis; perform periodic functional tests on plant systems Perform administrative work related to data reporting and operating procedures Check the plant regularly, reports malfunctions to the shift supervisor and makes work request Perform shift turnovers and assures the transfer of the necessary information Make suggestions for plant and operating procedure improvements Supervise the loading and unloading of chemicals to and from the trucks Responsible for the cleanliness and tidiness of the control room and other rooms used by operations Follow up the availability of operational consumables and reports deviation as needed Take initiatives to drive growth for DCBL and ensure sustained growth in line with long-term and short-term objectives of the organization Ensure initiation and sensitization of the employees towards digitization and automation of the processes Focus on utilization of advanced business analytics tools to derive key insights critical for the success of the organization 2 Environmental and Health Safety Considerations Responsible for performing the operational activities to meet standards of public safety, employee safety and environmental citizenship that meet or exceed regulatory requirements Responsible for the implementation of the work permit system and suggests improvements to the Safety Head Report dangerous hazards on plant systems, work place, working environment and general public Ensure that the plant does not violate any of the environmental rules and report problems 3. Self/ Team Development Review and monitor performance of team members and provide requisite developmental support/ inputs Complete the IDP Execution for self and team members as part of self and subordinate development Recommend training as required for teams development Develop the team and update their knowledge base to cater the organization need Strategize avenues for enhancing employee satisfaction in the function, resulting in high engagement levels of employees

Long Description 1 Exposure to perform the testing of Inprocess, Finished product, Stability and Cleaning validation samples etc. 2 Having knowledge of Analytical Instruments to perform the testing by HPLC, GC, UV, IR, KARL FISCHER etc. 3 Having Analytical testing skills to perform the MDI/DPI Products test like Assay, APSD, DDU, RS, Spray Pattern, FPM and physical testing etc. 4 Exposure of Laboratory investigation like OOS, OOT, Incidence, Deviation. 5 Exposure of Stability sample management & Regulatory Audits. 6 Exposure of Analytical method transfer, Analytical method validation / Verification activity. 7 Knowledge of GLP and Good documentation Practices. Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence Education Graduation in Pharmacy Work Experience 5 to 8 years

Laxmi Organic Industries Limited We are looking for candidates interested in Technical Associate - Electrical for Dahej. Total Experience 6-8 years with Supervisory License Job Title: Technical Associate Electrical Department: Engineering Reporting to: Sr. Manager Electrical & Instrumentation Functional Area: Electrical Location: Dahej Site IV Job Purpose : Maintaining normal & optimum operation of the plant (field and panel) Role and Responsibilities Strategic : Responsible to prepare the relevant shut down activities & Carrying out the jobs as per requirement. Operational: To check the status of the following day to day. a. Power factor reading. b. Status of all the drives parameters in the panel. Ensure that the preventative maintenance of transformer, PCC, MCC,IMCC, Turbines & all electrical drives is carried out Ensure that the readings of MSEB meter are correct. Ensure DG Set always in healthy condition by taking trials & always be available during power failure. Prepare purchase requisition as per requirement. Complete QESH & RC activity like audit, incident & documentation within time. Responsible for evolution of daily power consumption & if deviations take corrective action. Responsible for Carrying out all activities by following safety norms. Responsible for execution of the work as per preventive maintenance schedule Ensure to follow safety norms to achieve zero accidents To participate in Root Cause Analysis of Various safety and process safety incidents, Monitor and ensure implementation of CAPA ( Corrective Actions & Preventive Actions) Reporting any near miss /incident or any non compliance To Support Various Process safety and Responsible Care Initiatives Implementation of operational controls as per requirement of the operation / activity Responsible to complete any other assignment given by the senior Knowledge of HT & LT breakers, relay coordination, Required Knowledge Awareness of consequences of departures from standard procedures QESH Education Essential: Diploma in Electrical Engineering Preferred: Experience Essential:6-8 yrs with Supervisory License If you are interested for this position, kindly share your updated cv on below email id. Email Id: viddhi.kharwa@laxmi.com Telephone No: 91-22-4910444-ext.513

Long Description Annual maintenance contract preparation and preventive maintenance of QC and IPQA instrument as per approved procedure. Breakdown handling of QC and IPQA instrument as per approved procedure. Upkeep the records of preventive maintenance and breakdown in SAP. Qualification of new instruments and SOP preparation. To participate in failure investigation related to malfunctions. To impart training to the analysts for instruments maintenance and troubleshooting. Co-ordination with vendor service engineer of service /breakdown related activities. To maintain GMP in QC laboratory, Real time documentation. Computer system validation of laboratory instruments. Execution and implementation of quality system in laboratory. Taking part in internal calibration, out-side calibration and reviewing calibration data. Taking part in instrument cleaning maintain & Maintenance of all laboratories indents. QAMS, Caliber-e-log related activities SAP Bill & invoice clearance PO & PR related activity software handling EDMS ,SAP, caliber E log, QAMS, LIMS. etc. Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence Education Graduation in Mechanical Engineering Work Experience 7 to 8 Years of experience in Quality Control as Instrument Engineer

Preferred candidate profile Qualification : B Pharma/ M Pharma Experience : Min 3 years in QMS in OSD TrackWise Change control CAPA Deviation Others : Shift : General Female candidates are also eligible. Interested candidate may share resume at hr.plant@zuventus.com

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

Roles and Responsibilities (Hiring for AQA Role, IPQA Role, QMS Role - API Background is Must) Ensure compliance with GMP, BMR, BPR, SOPs, and quality systems. To Perform Analytical QA Role IPQA Activities QMS Activities Validation Activities Collaborate with cross-functional teams to ensure timely completion tasks Person Should be from the API Background

Roles and Responsibilities Conduct quality control activities such as BMR reviews, stability studies, process validation, and equipment qualification. Ensure compliance with cGMP guidelines and regulatory requirements through IPQA activities. Investigate deviations and CAPAs to maintain product quality and prevent recurrence of issues. Collaborate with cross-functional teams for change control processes and batch manufacturing record (BMR) review. Perform analytical testing using HPLC/GC/UV methods to ensure product purity. Desired Candidate Profile 2-7 years of experience in API manufacturing or bulk drug industry only male candidate. MS/M.Sc(Science) degree in Chemistry or related field; . Strong understanding of Good Manufacturing Practices (cGMP), Current Good Laboratory Practice (cGLP), and International Organization for Standardization (ISO). Proficiency in handling chemicals safely according to OSHA regulations.

What you will do Let's do this. Let's change the world. In this vital role you will be responsible for leading and charting the course for the Digital Quality Management System (DQMS) product team that builds and transforms technology capabilities that positively impacts business outcomes. Specifically, this individual will be responsible for planning, design, configuration, deployment, and support of Veeva Digital QMS solution. The ideal candidate will have a consistent track record of leadership in technology-driven environments for the Information Systems area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence. The candidate will have a strong background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational strategic initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Lead a team responsible for the ongoing management, optimization, and innovation of Amgen's Digital QMS platform Lead technical teams to design system configurations, data mappings, and integrations between Veeva platforms and other quality systems Ensuring data integrity by defining data quality standards, monitoring data quality issues, and working with data stewards to address discrepancies Supporting the validation processes defined by Amgen for the Veeva QMS, ensuring compliance with regulatory standards (e.g., FDA, GxP) throughout the implementation and ongoing usage Responsible for leading, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an escalation point and facilitating communication when service commitments are not met Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership Maintain strategic relationships and good communication with the leadership team about IS services and service roadmaps to ensure that all the collaborators feel informed and engaged Lead and manage large, diverse teams within a matrixed organization Collaborate with geographically dispersed teams, including those in the US and other international locations Lead all aspects of the software development lifecycle Develop and implement strategic plans for technology and workforce Develop a culture of collaboration, innovation, and continuous improvement Understand the decision-making process, workflows, and business and information needs of business partners and collaborators Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Ensure communication of key performance metrics and analysis of unmet needs Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services Ensure alignment of Technology service plans across organization Provide education to new partners with regards to IT service offerings What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate Degree and 2 years of experience in Business, Engineering, IT or related field OR Master's degree with 810 years of experience in Business, Engineering, IT or related field OR Bachelor's degree with 1014 years of experience in Business, Engineering, IT or related field OR Diploma with 1418 years of experience in Business, Engineering, IT or related field Solid understanding of QMS processes, including Deviation, Change Control, SQM & Audit & Inspections Expertise in Veeva QMS functionalities, including configuration, reporting, and workflow management Demonstrated experience in leading technology initiatives and teams with a track record of successful innovation Exceptional collaboration, communication and interpersonal skills to effectively manage partner relationships and build new partnerships Experience in applying technology best practice methodologies Scaled Agile (SAFe), ITIL, etc. Preferred Qualifications: Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle with technology used in a GxP environment Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities Ability to work effectively in a fast-paced, dynamic environment Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Scaled Agile Framework (SAFe) for Teams required Soft Skills: Excellent leadership and team management skills Strong transformation and change management experience Exceptional collaboration and communication skills High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented with a focus on achieving team goals Strong presentation and public speaking skills Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams

What you will do Let's do this. Let's change the world. In this vital role you will be responsible for leading and charting the course for the Digital Quality Management System (DQMS) product team that builds and transforms technology capabilities that positively impacts business outcomes. Specifically, this individual will be responsible for planning, design, configuration, deployment, and support of Veeva Digital QMS solution. The ideal candidate will have a consistent track record of leadership in technology-driven environments for the Information Systems area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence. The candidate will have a strong background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational strategic initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Lead a team responsible for the ongoing management, optimization, and innovation of Amgen's Digital QMS platform Lead technical teams to design system configurations, data mappings, and integrations between Veeva platforms and other quality systems Ensuring data integrity by defining data quality standards, monitoring data quality issues, and working with data stewards to address discrepancies Supporting the validation processes defined by Amgen for the Veeva QMS, ensuring compliance with regulatory standards (e.g., FDA, GxP) throughout the implementation and ongoing usage Responsible for leading, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an escalation point and facilitating communication when service commitments are not met Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership Maintain strategic relationships and good communication with the leadership team about IS services and service roadmaps to ensure that all the collaborators feel informed and engaged Lead and manage large, diverse teams within a matrixed organization Collaborate with geographically dispersed teams, including those in the US and other international locations Lead all aspects of the software development lifecycle Develop and implement strategic plans for technology and workforce Develop a culture of collaboration, innovation, and continuous improvement Understand the decision-making process, workflows, and business and information needs of business partners and collaborators Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Ensure communication of key performance metrics and analysis of unmet needs Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services Ensure alignment of Technology service plans across organization Provide education to new partners with regards to IT service offerings What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate Degree and 2 years of experience in Business, Engineering, IT or related field OR Master's degree with 810 years of experience in Business, Engineering, IT or related field OR Bachelor's degree with 1014 years of experience in Business, Engineering, IT or related field OR Diploma with 1418 years of experience in Business, Engineering, IT or related field Solid understanding of QMS processes, including Deviation, Change Control, SQM & Audit & Inspections Expertise in Veeva QMS functionalities, including configuration, reporting, and workflow management Demonstrated experience in leading technology initiatives and teams with a track record of successful innovation Exceptional collaboration, communication and interpersonal skills to effectively manage partner relationships and build new partnerships Experience in applying technology best practice methodologies Scaled Agile (SAFe), ITIL, etc. Preferred Qualifications: Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle with technology used in a GxP environment Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities Ability to work effectively in a fast-paced, dynamic environment Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Scaled Agile Framework (SAFe) for Teams required Soft Skills: Excellent leadership and team management skills Strong transformation and change management experience Exceptional collaboration and communication skills High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented with a focus on achieving team goals Strong presentation and public speaking skills Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams

Job description Should have sound knowledge of QMS System and Change Control, Deviation and CAPA Procedure. Review of Preventive maintenance & calibration of equipment and systems. Investigation and closure of all deviations, OOS and complaints

Establish / maintain compliance with FDA QSRs (GMP) Working with Production teams to develop validation protocols for production processes, and generating the final report covering the validation results and a recommendation for approval or disapproval for the release of the process to manufacturing. Export compliance system, Compliance of labeling, quality control and a quality system for excipients Documentation Control Process and Documentation Change Control Process Good Documentation Good Communication

1) Understand the CTQ for a process 2) Ensure complaince of process parameters and product parameters for the responsible area 3) Educate the operators and ensure adherence of GMP/quality systems in the process 4) indentify non conformances, Deviations- segeregate and quarantine the materials and reporting 5) Basic quality trouble shooting guidelines implementation to assist production to ensure Quality 6) System updation in ERP/ material clearance process completion 7) Deviation process controls 8) customer CTQ CAPA implentation points checking for effectiveness 9) maintaining of the correspoding Lab equipments and testing as per audit plan and reporting and taking actions on NC 10) Reporting of abnormality on Machine quality automations like EVS, magnetic separator etc.,

About Us Tata Consulting Engineers Limited (TCE) is the largest Indian private sector engineering and project consultancy and an emerging global leader in integrated engineering solutions. With more than 60 years of engineering excellence, TCE has a presence in over 64 countries and over 12000 completed projects, the company operates in 3 core Industry segments -Infrastructure (Water, Environment, Urban Development, Buildings, Manufacturing Facilities, Ports and Harbours, Transportation), Power (Thermal, Hydro, Nuclear, Renewable, Transmission and Distribution) and Resources - Hydrocarbons and Chemicals (Oil, Gas and Refineries, Chemicals, Petrochemicals, Fertilizers, Speciality Chemicals, Pulp and Paper, Cement, Food, Pharmaceuticals and Beverages, Tyre, Glass) as well as Mining and Metallurgy (Mining, Geology, Beneficiation, Steel, Non-ferrous). TCE serves domestic as well as international markets and is known for several first-of-its-kind projects offering Engineering Studies, Design Engineering Services, Project Management Consultancy Services, OPEX and IIOT across all three verticals. A part of Tata Group - India’s most respected group, TCE is a 100 percent subsidiary of Tata Sons Limited Design your Future with us At TCE, you will experience a supportive environment that empowers you to excel, whether you are based in our offices or at a client site. We embrace diversity, equity, and inclusion, fostering a workplace where every individual can thrive by contributing their unique skills and perspectives to deliver exceptional results for our clients. Our comprehensive compensation and benefits packages are designed to meet the diverse needs of our employees and their families, complemented by a robust global well-being program. As a leading global infrastructure firm, we are committed to your growth and success, offering access to cutting-edge technology and impactful projects that offer flexibility and significant professional opportunities. Join us and become part of a global company that values your potential and supports your career development. Purpose & Scope of Position The Project Engineer (PE) will be part of an engineering stream providing engineering services to large and small projects. The PE provides support to the Project Manager (PM) and Engineering Manager (EM) and is responsible for supervising a team of working engineer and designers. The PE provides leadership and assists in the resolution of all technical issues related to the discipline. Experience • 10+ years of experience in relevant design discipline • Experience in engineering and package coordination Qualification • Postgraduate or graduate in an engineering discipline • Registration as a professional engineer with the governing authority (preferable) Key Responsibilities 1. Assist the PM and EM with the delivery of project requirements as they relate to scope, quantities, cost and schedule 2. Prepare Engineering Work Packages (EWPs) in consultation with the Engineering Manager 3. Assist in the compilation and delivery of monthly engineering status reports 4. Participate in and contribute to design reviews 5. Represent the discipline in the project engineering coordination meetings 6. Prepare and/or review project procedures, standard specifications and design criteria 7. Review and evaluate technical work prepared by junior engineers, intermediate engineers, designers, technicians and technologists 8. Ensure relevant technical experts are involved in the design process as required and facilitate the sharing of technical expertise across projects 9. Perform conceptual and detailed engineering design 10. Prepare engineering work (calculations, reports, specifications, evaluations, recommendations etc.) where required 11. Provide and/or coordinate training for resources assigned to the project 12. Work to ensure the implementation of safety in design 13. Ensures measurement of progress on all contracts for reporting and progress claim purposes. 14. Responsible to ensure timely availability of discipline data to other disciplines, and work with fellow PEs and EM on integration of the same and resolution of any issues and challenges 15. Document value additions and best practices and ensure communication of the same to fellow project engineers of other projects and discipline leadership 16. Support technology team/ Project team for development and automation works as required. 17. Ensure compliance to all quality and document management processes within TCE and as agreed with customer. 18. Manage performance data of reportees and provide periodic feedback. 19. Provides resource loading forecast to TL. 20. Keeps records of learning’s during the project and provides inputs to PM during job closure report. 21. Prepare technical specifications/ bid evaluation/ technical recommendation where required 22. Interact with the discipline engineers of customer during entire life cycle of the project and beyond. Competencies Action Oriented Manages Complexity Technical Knowledge Quantity of Work Knowledge