143 Pq Jobs

Day-to-day design and documentation activities (i.e. Validation Documents, DQ, IQ, OQ, Operating Instruction Manual etc. AutoCAD 2D Drawing (GA Drawing, Layouts, Part Drawing) Measuring Instruments & Basic Knowledge of Standard Mechanical Components.

Quality Assurance Compliance Specialist Location: Pune-Hybrid working-Twice a week in the office Status: Permanent, Full Time Package: Competitive Salary (fixed), 5 Day Working Week, Flexible Working (with one-off allowance), Development & Opportunity (Personal & Technical), Group Medical Policy, Group OPD Cover, Personal Accident Cover, Term Life Cover, 26 Days Leave + 9 Public Holidays + Buy & Sell Scheme, Referral Scheme. Why are we hiring a Quality Assurance Compliance Specialist? Were on the hunt for a Quality Assurance Compliance Specialist as part of our company’s growth. The Quality Assurance Compliance Specialist provides day-to-day support for Quality Assurance and Information Security Management teams and other activities as required within the Governance, Risk Management and Compliance group (GRC), to help ensure our quality and information security objectives are met at all sites and to allow the business to reliably manage governance, identify and manage risks and provide independent oversight to ensure the business remains compliant accordingly. Who’s Instem? Well, we’re a global provider of bespoke industry-leading software solutions and services, which facilitate the pre-clinical, and clinical phases of the drug discovery process. We have over fifteen products in our portfolio, used by over 700 pharmaceutical clients (including all the top 20!) Instem is a unique, solutions-based organisation. Our 5-year growth plan is progressive, and we need you to help us reach that next level! What’s the culture/environment like? For a global business of over 300 staff, we very much have a family feel. You’ll be part of a friendly, communal, solution based, flexible environment, where you’ll feel empowered, valued and accountable. We’ll invest in you as a person and encourage you to take part in companywide workshops for wellbeing, mental health, critical conversations, and strengths. What are you responsible for? Planning and executing Internal Process Audits Execute Software Release Audits Supplier Assessment/Qualification/Performance Reviews (quality aspects) Review, authoring and modifying and preparing for publication management system documents Logging/tracking corrective action updates Adherence to the Company’s Quality and Information Security Management Systems to ensure that all work is handled Securely, Professionally and Diligently To be successful in this role, you will need: Certified lead auditor for ISO 9001 Skilled at building good working relations with auditees and their managers Sound planning and coordination skills Broad knowledge of Instems products and services Broad technical understanding of software development lifecycle Knowledge of Quality Management and Information Security Management and its application to tasks associated with this role Conversant with GxP such as 21 CFR Part 58 and ERES such as 21 CFR Part 11 Daily, millions of lives are improved by the Instem technologies and services that have been deployed by our clients. This is a fantastic opportunity for you to help save and prolong people’s lives, by doing what you do best! An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Instem stores and processes data using an Applicant Tracking System (ATS). For more information regarding our privacy policy use the following link: https://www.instem.com/privacy/ #LI-PD #LI-Hybrid

Work Flexibility: Hybrid What you will do: Support the implementation of process improvements to Corporate/Site/Division Supplier Initiated Change Request procedures and process. Served as owner, execute, and maintain the electronic systems related to SICRs, and support data alignment (SICR Database & OnePLM SICR Library) Challenge suppliers SICRs forms for completeness and accuracy. Discuss corrections to the form to guarantee a smooth assignment and execution of the change. Own & Execute Supplier Initiated change request (SICR) submitted by Global Suppliers Review Submitted SICRs and challenge suppliers for missing information & required deliverables for approving the change Organize SCRB with Key Stakeholders and get Buy in for Type of change. Review and Approve deliverables submitted by suppliers and coordinate with supplier for any corrections. Execute ECR/ECNs and Promotion requests in OnePLM for Change Approval at Stryker end. Support communication tools to internal and external customers (suppliers/site/division) Monitor and Maintain SICR KPIs. Support Global SICR Initiatives What you will need: Required qualification: Honors Bachelors degree in Engineering or Science fields or equivalency. 3+ years of experience in manufacturing environment or equivalent. Basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards Good communication skills. Willing to travel in support of business needs to different geographical locations. Good knowledge of continuous improvement methodologies Hands on experience of PPAP ,MSA, SPC documentation creation, review and Approval from suppliers. Good Hands on experience of Validation activity IQ,OQ & PQ Good Know how of Manufacturing processes like welding, Molding, Machining etc. Good Hands on experience of PFMEA & Control Plan Preferred qualification: Must enjoy working in a team environment Must demonstrate good collaboration and communication skills. Highly motivated and able to build relationships internally and externally. Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time. The individual should enjoy working in a dynamic and results-oriented team environment focusing on quality, compliance and customer satisfaction Travel Percentage: 10%

Role & responsibilities Key Responsibilities: A.) Software Application Rollout of P2P automation (developed by vendor) including Vendor Registration, PR, RFQ, PQ, CS, NFA, ASN, SRN, Service Entry Sheet, RGP, NRGP, and DC generation. Manage licenses (Premium, Team Member, Device-based) and assign as per user activity. Oversee cloud updates, AMC support, and partner managed services . Maintain roles, permissions, and workflows as per Segregation of Duties (SOD) and MakerChecker concept. Ensure Sandbox UAT testing before Go-Live for automation/customizations. Perform monthly & yearly closure activities in Business Central. Ensure efficient Business Central storage utilization by implementing Change Log archival and optimization practices. B.) Hardware, Network & Windows Troubleshooting Install, maintain, and troubleshoot of desktops, laptops, printers, biometrics, and other hardware (AMC/Non-AMC). Manage Cisco LAN switches, UTM appliances, Wi-Fi devices, and conduct RCA for network failures. Handle installation, upgrade, and license management of Windows OS, Microsoft 365, Dynamics 365 Business Central, Power BI, and essential business software. Maintain IT racks, server room equipment, and MATRIX intercom systems for uninterrupted communication. Oversee CCTV/NVR surveillance, manage AMC contracts, and implement AI-based security solutions. Preferred candidate profile

Capgemini Invent Capgemini Invent is the digital innovation, consulting and transformation brand of the Capgemini Group, a global business line that combines market leading expertise in strategy, technology, data science and creative design, to help CxOs envision and build whats next for their businesses. Your Role Use Design thinking and a consultative approach to conceive cutting edge technology solutions for business problems, mining core Insights as a service model Engage with project activities across the Information lifecycle. Understanding client requirements, develop data analytics strategy and solution that meets client requirements Apply knowledge and explain the benefits to organizations adopting strategies relating to NextGen/ New age Data Capabilities Be proficient in evaluating new technologies and identifying practical business cases to develop enhanced business value and increase operating efficiency Architect large scale AI/ML products/systems impacting large scale clients across industry Own end to end solutioning and delivery of data analytics/transformation programs Mentor and inspire a team of data scientists and engineers solving AI/ML problems through R&D while pushing the state-of-the-art solution Liaise with colleagues and business leaders across Domestic & Global Regions to deliver impactful analytics projects and drive innovation at scale Assist sales team in reviewing RFPs, Tender documents, and customer requirements Developing high-quality and impactful demonstrations, proof of concept pitches, solution documents, presentations, and other pre-sales assets Have in-depth business knowledge across a breath of functional areas across sectors such as CPRD/FS/MALS/Utilities/TMT Your Profile B.E. / B.Tech. + MBA (Systems / Data / Data Science/ Analytics / Finance) with a good academic background Minimum 10 years + on Job experience in data analytics with at least 7 years ofCPRD, FS, MALS, Utilities, TMT or other relevant domain experience required Specialization in data science, data engineering or advance analytics filed is strongly recommended Excellent understanding and hand-on experience of data-science and machine learning techniques & algorithms for supervised & unsupervised problems, NLP and computer vision Good, applied statistics skills, such as distributions, statistical inference & testing, etc. Excellent understanding and hand-on experience on building Deep-learning models for text & image analytics (such as ANNs, CNNs, LSTM, Transfer Learning, Encoder and decoder, etc). Proficient in coding in common data science language & tools such as R, Python, Go, SAS, Matlab etc. At least 7 years experience deploying digital and data science solutions on large scale project is required At least 7 years experience leading / managing a data Science team is required Exposure or knowledge in cloud (AWS/GCP/Azure) and big data technologies such as Hadoop, Hive, What you will love about working here We recognize the significance of flexible work arrangements to provide support. Be it remote work, or flexible work hours, you will get an environment to maintain healthy work life balance. At the heart of our mission is your career growth. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities. Equip yourself with valuable certifications in the latest technologies such as Generative AI. About Capgemini Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of 22.5 billion.

Preparation of documents such as IQ, OQ, DQ Job Description- (Incumbent needs to do/ Needs to know/ Outcome anticipated) Preparation of Project documents such as IQ, OQ, DQ as per requirement Incumbent needs to know - Basics of documents such as IQ, OQ, DQ - Excel, Word Experience Handling documentation activities for Minimum 6 months, preferably for WT projects in pharma.

Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and fixtures for development and manufacturing Subject matter expert in the material properties of thermoplastic polymers and balloon forming processes to ensure optimized design inputs and outputs Support development of equipment, process, and measurement strategy as related to Balloons Plans, organizes, and manages related projects and staff as appropriate Train, mentor, and provide direction to Operators and Technicians. Support sustainable operations as a subject matter expert Design and integrate related test methods Understand customers applications and design products to meet application demands Lead the development of balloon forming equipment, process, and measurement strategy Directly review and validate the measurement results of development balloon runs Collaborate across operations and engineering teams to build consensus, summarize data to drive progress, to draws conclusions, and to create recommendations Qualifications Bachelor s Degree in Chemical, Mechanical, Material Science, or other related fields. A minimum of 5 years of industry experience in a manufacturing environment Extrusion/Injection molding/related experience preferred Innovative idea-generator who enjoys leading teams and mentoring others Problem-solving mindset backed up by solid statistical analysis skills Self-starter, self-motivator with the ability to work effectively in a team environment 1+ years of experience of indirectly providing direction to support technicians is preferred IQ/OQ/PQ experience a plus Six Sigma, lean certification a plus SAP experience a plus Competencies Location

Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and fixtures for development and manufacturing Subject matter expert in the material properties of thermoplastic polymers and balloon forming processes to ensure optimized design inputs and outputs Support development of equipment, process, and measurement strategy as related to Balloons Plans, organizes, and manages related projects and staff as appropriate Train, mentor, and provide direction to Operators and Technicians. Support sustainable operations as a subject matter expert Design and integrate related test methods Understand customers applications and design products to meet application demands Lead the development of balloon forming equipment, process, and measurement strategy Directly review and validate the measurement results of development balloon runs Collaborate across operations and engineering teams to build consensus, summarize data to drive progress, to draws conclusions, and to create recommendations Qualifications Bachelor s Degree in Chemical, Mechanical, Material Science, or other related fields. A minimum of 5 years of industry experience in a manufacturing environment Extrusion/Injection molding/related experience preferred Innovative idea-generator who enjoys leading teams and mentoring others Problem-solving mindset backed up by solid statistical analysis skills Self-starter, self-motivator with the ability to work effectively in a team environment 1+ years of experience of indirectly providing direction to support technicians is preferred IQ/OQ/PQ experience a plus Six Sigma, lean certification a plus SAP experience a plus Competencies Location

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

Job Description Business: Piramal Critical Care Department: Information Technology Location: Kurla Travel: Low Job Overview To perform and document Computer System Validation of GxP Systems as per defined processes at Central Partner Functions and across Piramal Critical Care sites. Key Stakeholders: Internal Business Site / Central Partner functions IT Team (e.g. SAP / Infra / Quality IT / Allied / SAP etc) Key Stakeholders: External IT Vendors, IT Contractors/Consultants, Piramal CSV Partner Reporting Structure Reports to: AGM IT - CSV Education Qualification & Experience Graduate in Science/Pharmacy/Engineering Post Graduation MPharm/Science/MBA (Desirable) Candidate with 10-14 years of experience in Pharma/Life science domain working on CSV, Part 11/Annex 11, Data Integrity Work experience in Pharma or IT Sector will be desirable Roles & Responsibilities Must have thorough understanding, practical approaches for Computer system validation (CSV) & Computer Software Assurance of enterprise level applications. Accountable to ensure compliance of CSV documentation during various phases (project, operational & retirement) of software lifecycle (SLC).Well aware with GAMP5, CFR Part 11/EU Annex 11 and Data integrity requirements. To create end to end CSV deliverables for IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. To create QMS documents e.g. Change control/Deviation/Incidents-Discrepancy/User access forms. To perform Root cause analysis and define CAPA based on QMS documents review. To support Quality Automations Initiatives across the Central Partner functions/PCC/PPL sites. To liaise with Site IT , Business SPOCs for CSV activities and IT Compliance initiatives. To guide and train IT & CSV teams (Central Partner Functions & Site) for CSV, and CSV Regulatory Compliance activities. To work along with Business, IT, QeC & Project Manager to ensure project timelines are met. Experience on validation of any of the enterprise level applications. e.g. Track wise, Ensur/Documentum, Paperless Validation Tools, LIMS, LMS, SAP, RIMS Applications, Artwork management Systems, Serialization, Veeva etc. Author, review and approval of SOPs, Guidelines/Policies as applicable. Competencies Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV, CSA,GAMP 5 Guidelines (Must) Good knowledge of Data Integrity requirements for Pharma (Must) Experience in working with various geographical Location Stakeholders such as US, European, APAC. (Must) Experience of working with Global Pharma Cross functional Sites QC, QA, Manufacturing, IT, SAP etc. (Plus) Experience of validation on automation/digitization projects (Plus) Good Verbal and Written communication skills (Must) Aware of industry best practices and knowledge about Pharma 4.0 (Plus) Functional knowledge of CSV Regulatory guidelines, Quality Control and Manufacturing processes (Plus) Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders. PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators. Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space. Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment. Show more Show less

About the role The SRM will ensure that business stakeholders manage suppliers in line with risk appetite, optimising post-contract value, and developing a transparently sustainable supply base. The role holder will collaborate closely with senior stakeholders from across FIL to establish broad internal stakeholder relationships, drive value from, and manage risk across the supplier portfolio. These stakeholders include but are not limited to: senior executives across FIL; Supplier Relationship Managers (SRMs) across FIL; Supplier Risk Oversight (Procurement 2LoD function); Senior Procurement Category leaders; and risk partners across FIL. The SRM will be use experience of supplier risk and relationship management to create clear supplier strategies (commercial, contractual and risk) for a defined element of the supplier portfolio, and will ensure the requirements contractual obligations, Procurement policy, and business unit objectives are met and evidenced in regular routines. About you Previous experience as a Supplier Relationship Manager is essential, with at least 3 years SRM FS experience desired. Experience of working within an Enterprise Risk Management framework model, with knowledge of the 3LoD model. It is essential the role holder demonstrate behaviours aligned to FILs Values and Behaviours. It is desirable for the role holder to have sound knowledge of key global regulations pertaining to Outsourcing and controls. Commercial awareness and ability to partner with Procurement to negotiate fees and contracts. Enthusiastic, self-driven and with a high level of self-motivation to overcome obstacles and a strong desire to make things happen. Strong personal presence, excellent interpersonal and communication skills, ability to establish a successful rapport, communicate and influence at all levels. Excellent organisational skills, presentation of reports and attention to detail. Strong decision-making skills. Ability to be flexible and responsive to a constantly changing environment.

About The Role Project Role : Business Process Architect Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Must have skills : Computer System Validation (CSV) Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will engage in the analysis and design of innovative business processes. Your typical day will involve collaborating with various stakeholders to create comprehensive documentation that directs the implementation of new processes and technologies. You will work closely with the business to define product requirements and use cases, ensuring that they align with both process and functional needs. Additionally, you will participate in user and task analysis, effectively representing the business's needs to facilitate successful outcomes. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Expected to provide solutions to problems that apply across multiple teams.- Facilitate workshops and meetings to gather requirements and feedback from stakeholders.- Develop and maintain process documentation to ensure clarity and consistency across projects. Professional & Technical Skills: - Must To Have Skills: Proficiency in Computer System Validation (CSV).- Strong analytical skills to assess business processes and identify areas for improvement.- Experience in process mapping and documentation techniques.- Ability to communicate effectively with diverse teams and stakeholders.- Familiarity with project management methodologies to ensure timely delivery of projects. Additional Information:- The candidate should have minimum 12 years of experience in Computer System Validation (CSV).- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

About The Role Project Role : Business Process Architect Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Must have skills : Computer System Validation (CSV) Good to have skills : NAMinimum 15 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will engage in the analysis and design of innovative business processes. Your typical day will involve collaborating with various stakeholders to create comprehensive documentation that directs the implementation of new processes and technologies. You will work closely with the business to define product requirements and use cases, ensuring that they align with both process and functional needs. Additionally, you will participate in user and task analysis, effectively representing the business's needs to facilitate successful outcomes. Roles & Responsibilities:- Expected to be a Subject Matter Expert with deep knowledge and experience.- Should have influencing and advisory skills.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Expected to provide solutions to problems that apply across multiple teams.- Facilitate workshops and meetings to gather requirements and feedback from stakeholders.- Develop and maintain process documentation to ensure clarity and consistency across projects. Professional & Technical Skills: - Must To Have Skills: Proficiency in Computer System Validation (CSV).- Strong analytical skills to assess business processes and identify areas for improvement.- Experience in process mapping and modeling techniques.- Ability to communicate complex concepts clearly to diverse audiences.- Familiarity with regulatory requirements related to computer system validation. Additional Information:- The candidate should have minimum 15 years of experience in Computer System Validation (CSV).- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

About The Role We are seeking a skilled and experienced MES Engineer with hands-on expertise inKrber Werum PAS-Xto support manufacturing operations in a regulated pharmaceutical or life sciences environment. The ideal candidate will have a strong technical foundation, validation knowledge, and excellent communication skills to effectively bridge the gap between technical teams and business stakeholders. Key Responsibilities:- MBR Design & Development: Design and create complex Master Batch Records (MBRs) for Weighing & Dispensing, Manufacturing, and Packaging processes. Analyze site-specific requirements and translate them into functional MBRs. Validate MBRs for deployment across manufacturing sites. System Configuration & Administration: Configure and customize Werum PAS-X modules including GMBRs, PVL, PMBRs, Equipment Management, Material Flow, Weigh & Dispense, EBR, and Master Data. Design and developState Diagramsand determine updates forMaster DataandEquipment Management. Integration & Interface Management: Work on SAP-MES interfaces, Level 2 (L2) integrations, and report development. Ensure seamless data flow and system interoperability. Compliance & Validation: Ensure compliance with GxP, GAMP, and 21 CFR Part 11 standards. Participate in validation activities includingIQ/OQ/PQand documentation. Project & Stakeholder Management: Act as an Offshore Lead and manage service delivery for PAS-X. Liaise with clients and stakeholders to gather requirements and provide technical solutions. Provide support forWerum PAS-X installation, upgrade, development, and configuration. Primary Skills (Must-Have): Strong hands-on experience withWerum PAS-X(Specification, Execution, Compliance & Performance Modules). Expertise inMBR creation,State Diagram design, andMaster Data configuration. Experience inPAS-X System Administrationandcustomization. Knowledge ofISA-95/S88 standardsand their application in MES design. Familiarity withSAP-MES integrationandL2 automation systems. Understanding ofpharmaceutical manufacturing processesand regulatory requirements. Secondary Skills (Good-to-Have): Programming knowledge inSQL,C#, andJava. Experience withuser management,system profile creation, andreporting tools. Exposure toITIL frameworksandIT service management. Experience inproject management,client communication, andteam leadership. IT Skills: SQL Queries C# (C-Sharp) Java Experience in: User management System profile creation System configuration and troubleshooting

Deloitte is looking for Deputy Manager | CSV | | SAP to join our dynamic team and embark on a rewarding career journey Assist the Manager in the day-to-day operations of the business, including setting goals, developing strategies, and overseeing the work of team members Take on leadership responsibilities as needed, including managing team members and making decisions in the absence of the Manager Identify and address problems or challenges within the business, and develop and implement solutions Collaborate with other departments and teams to ensure smooth and efficient operations Maintain accurate records and documentation Contribute to the development and implementation of business plans and goals

Role & responsibilities .Department - Production (Fill-Finish) Jr. Operator / Operator / Sr. Operator Job Description: Depyrogenation, HPHV Steam Sterilizer, Production related activities, Lyophilizer, Vial filling & Sealing machine operations & Formulation activities Experience: 1 - 6 years Qualification: ITI/Diploma/B. Sc/Equivalent Job Description: Officer / Executive /Jr Executive Production plan, filling activities, cGMP, SOP, Preventive maintenance, Lyophilizer, Aseptic Media fills, HPHV, Handling Filter integrities, DQ, IQ, PQ, OQ. Experience: 1 - 6 years Qualification B. Pharmacy / M. Pharmacy What should you carry 1. Updated resume 2. Latest increment letter with last three months pay slips Preferred candidate profile

Job Characteristics: Leads software development projects through the phase gate process. Leads requirements gathering efforts of the software team to ensure that customer and divisional needs are met. Manages interactions between team & stakeholders to ensure seamless project integration. Writes code to address challenging aspects of the project. Writes the standard documentation used to translate project needs into software design specifications. Assists in creating overall architecture for various software systems. Corrects challenging defects found through QA software testing and systems testing. Supports field test personnel after development with issues not addressed by software engineers in lower levels. Often coaches and advises other engineers. May oversees external contractors and consultants. Assists in defining the process by which software is designed and developed. Activities ensure that software development projects progress properly, and result in quality software that meets customer and divisional expectations. Education/Work Experience: Typically requires a degree and 8+ years experience; or no degree and 12+ years combined education and equivalent work experience (typically 1 year experience = 1 year education). Independence Level/Reports to: Recognized master in professional discipline typically obtained through advanced education and work experience. Responsibilities typically include: establishing operational plans for job area. Developing and implementing new products, processes, standards or operational plans that will have impact on the achievement of functional results. Requires communication with leadership. Normally Reports to Sr. Leader or Director.

Ensure accurate and timely processing of invoices and monitor incoming payments. Manage and oversee the daily operations of the AR department including invoice processing, payment processing, and account reconciliation. Knowledge of TDS & GST. Secure revenue by verifying and posting receipts and resolving any discrepancies. Maintain accurate records and control reports for all AR transactions. Use accounting software and MS Excel to process business transactions and compile reports. Collaborate with other departments to ensure billing accuracy. Address and respond to customer inquiries regarding invoices and payments. Ensure compliance with accounting principles and company procedures. Participate in financial audits and implement audit recommendations. Contribute to team efforts by accomplishing related results as needed. Drive operational excellence and continuous improvement in the AR process. Handle refund processes efficiently and effectively. Demonstrate a global mindset and entrepreneurial spirit in all tasks and projects. Foster a culture of people excellence within the team. The candidate should have a strong financial and commercial acumen, with a deep understanding of accounting principles and proficiency in accounting software. The candidate should also have excellent problem-solving skills, be a team player, and have a strong focus on customer service.

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

Skill Required Roles and Responsibilites 1. Media fill and qualification summary preparation knowledge. 2. To maintain track of qualification and validation activities. 3. To prepare and review the protocols and reports. Execution of various qualification / validation activities. 4. To review correctness of the technical documents received from the supplier (DQ/OQ/IQ/PQ,FAT). 5. Co-ordinate with production and other user department for qualification/validation activities 6. Timely compile and review of qualification validation reports. 7. To review the equipment documents like calibration reports and ensure correctness of documents. 8. To perform FAT. 9. To co-ordinate with outside agencies for execution of qualification activity whenever required. 10. Identification of deviation through review and observation. 11. To prepare annual Re-qualification/validation schedule, update VMP and Qualification related SOPs as and when required. Qualification Required B. Pharm/ M. Pharm/ MSC. Relevant skills / Industry experience 2 to 3 years experience in USFDA, MHRA, TGA approved plant

As a Process Incharge - Injectable, you will be responsible for overseeing formulation manufacturing projects with an experience requirement of 12-15+ years, including 5-6 years specifically in formulation manufacturing projects. Your key responsibilities will include reviewing equipment design qualification documents such as PI&D, FS, DQ, SDS, HDS, IQ, OQ, and drawings for approval when necessary. You will be tasked with verifying process equipment instruments in alignment with PI&D and electrical drawings, ensuring commissioning of instruments as needed, and conducting Factory Acceptance Tests (FAT) for process equipment where necessary. Additionally, you will provide support for installation and commissioning activities and assist in the qualification of equipment through IQ, OQ, and PQ processes. Furthermore, you will collaborate with the team to identify all process equipment and utilities equipment field instruments, create calibration schedules, and manage the instrumentation team for calibration activities. You will also be responsible for approving third-party calibration vendors, reviewing calibration certificates, and coordinating with vendors for spares indents and Quality Management System (QMS) elements like change control and deviations. Your role will also involve attending to equipment maintenance tasks such as preventive maintenance and breakdowns, as well as preparing Standard Operating Procedures (SOPs) and obtaining necessary approvals. If you are interested in this challenging opportunity, please share your CV with us at nitin.shringi@knovea.com.,

The Document Controller position at SEPAM in Chennai is a full-time on-site role that involves managing project documentation, records, and communication tasks related to document management. The ideal candidate should possess hands-on experience in GMP, Equipment Qualification, DQ/IQ/OQ/PQ, as well as experience in FMCG projects. Key responsibilities include document management, project documentation, and records management. The successful candidate will need to demonstrate strong communication skills, attention to detail, and organizational skills. Proficiency in document control software is essential for this role. Additionally, the ability to work effectively in a team environment is crucial. Candidates should hold a Bachelor's degree in a relevant field to be considered for this position.,

You will be responsible for leading the execution of the SICR strategy at our organization by building and nurturing a highly capable and scalable team. Your role will involve challenging divisional processes to drive high-yield, cross-divisional outcomes. In addition, you will drive thorough SICR scrubbing to capture all relevant details, challenge suppliers, and maximize service, quality, and cost benefits. Coaching and developing subject matter champions to actively shape process improvements and ensure compliance with Stryker procedures will also be a key aspect of your responsibilities. Regularly reviewing SICR aging reports, collaborating with sourcing to cancel or deny cases with obsolete or delayed deliverables, and supporting reduced execution times through innovative problem-solving will be crucial for ensuring execution efficiency. You will also identify and implement division-wide process improvements by leveraging best practices to eliminate inefficiencies and track SICR KPIs and timelines to address bottlenecks and drive productivity gains. Building trust with global leadership, effectively collaborating with internal customers and cross-functional partners, and positioning the team as SICR subject matter experts will be essential in your role. Furthermore, preventing backorders and revenue risk through effective SICR management and revenue protection/backorder impact calculations will contribute to protecting business operations. **Basic Qualifications:** - Bachelor's degree in engineering, Science discipline or equivalent. Business Management or MBA is an advantage. - Minimum of 10 years" experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive, or regulated manufacturing environment. - Experience in creating and managing a talented, engaged, and performing team is advantageous. - Ability to implement organizational and functional strategy, initiate and implement change with a demonstrated track record, and hands-on experience of Validation activities like IQ, OQ & PQ. - Good knowledge of Manufacturing processes such as welding, Molding, Machining, and quality tools like SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools. **Preferred Qualifications:** - Strong collaboration and communication skills. - Highly motivated with the ability to build relationships internally and externally. - Proficient in multitasking and working in a dynamic, results-oriented team environment focusing on quality, compliance, and customer satisfaction. Join us at Stryker, a global leader in medical technologies dedicated to making healthcare better for patients worldwide. Our innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine aim to improve patient and healthcare outcomes, impacting over 150 million patients annually.,

You will be responsible for documentation and execution of qualification activities. This includes preparation, review, and execution of URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ (Requirement Qualification) documents. Your responsibilities include the review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems. You will be responsible for new project-related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test). You will review and compile raw data, relevant certificates, analysis test reports, and preparation and review of the final summary report. Additionally, you will be responsible for preparation and review of protocols and reports for media fill validation and cleaning validation. Your role involves the initiation of relevant CRN (Change Request Number) for new or existing activity, timely closure of assigned action plans as per CRN, and CRN review and approval. You will also be responsible for corrective and Preventive Action (CAPA) implementation and handling incident investigations and CAPA related to qualification. As part of your role, you will prepare and review VMP (Validation Master Plan), conduct training for employees and external vendors as a qualified trainer, and prepare and review qualification SOPs (Standard Operating Procedure). You will conduct investigations as a site investigation team member and update the Qualification status label. You will be responsible for the periodic qualification schedule preparation, updating, and execution, as well as the qualification of new or transferred equipment. Additionally, you will provide necessary assistance and support to various regulatory, internal, and external inspections.,

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