10 Gamp5 Jobs

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

Provide expert consulting on designing, optimizing, and implementing quality management systems, ensuring alignment with industry best practices and regulations. Required Candidate profile 3+ years eClinical software exp; 8+ years in quality assurance/compliance/management within U.S. pharma; Deep knowledge of regulatory frameworks: FDA regulations, ICH GCP, 21 CFRPart 11.

As an Engineer A&C Master Software at our company serving pharmaceutical and nutraceutical companies worldwide, you will be responsible for the control architecture design and PLC/HMI/SCADA software programming as per requirements. Your main duty will be developing the Master Application Program in PLC for products utilizing IEC61131 compliant programming language. It is essential to ensure thorough testing and a first-time-right approach before releasing the software program to the operation and manufacturing teams. You will be accountable for the design, creation, and testing of PLC Level 1 module software code to release Product code PLC Level 1 modules. Additionally, your role will involve designing, creating, and testing Servo drives and VFDs to release Product code for Servo drive & PLC level 1 modules. You will also be responsible for the design, creation, and testing of VFDs, releasing Product code & VFD setting via PLC level 1 modules. Furthermore, your responsibilities will include designing and creating product code PLC Level 2 & 3; Servo, VFD, and interfaces to release Product code PLC, Servo, VFD, and Interfaces for the machine portfolio. You will need to manage synchronized Master care for testing, releasing, and version control for PLC, VFD, Servo Drive software code. Moreover, you will be in charge of authoring, updating SOPs, Automation software company standards, and ensuring awareness by conducting training sessions. As part of your role, you will coordinate with control system (PLC & SCADA) vendors for developing technical solutions and drive knowledge sharing of GAMP5, Validation, and 21CFR Part-11 regulations & requirements. This is a full-time, permanent position with a day shift schedule and the work location is in person at Pune/Mumbai. If you meet the experience requirement of 4 to 5 years and hold a BE in Electrical/Electronics/Instrumentation, with mandatory experience in B&R PLC, we encourage you to apply for this challenging and rewarding opportunity.,

Date: 12 Aug 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Manufacturing Services Job Description Designation: Deputy Manager Level: 7 - II Job Location: Bangalore The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngenes 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. Position Summary We are seeking a highly skilled and motivated Process Automation Engineer with a strong background in biopharmaceutical process design and/or manufacturing . The ideal candidate will bring hands-on expertise in automation systems , particularly within Upstream operations and add on experience in Downstream operations (chromatography, ultrafiltration/diafiltration, nanofiltration). This role offers the opportunity to work on cutting-edge projects in process automation, recipe management, and control system design using advanced platforms and will extend to digital transformation Functional Responsibilities Design, develop, and implement automation solutions for Upstream and downstream operations Develop process control strategies in compliance with ISA S88 standards for batch process automation Create, configure, and validate recipe management systems for complex biopharma operations Design and implement PLC-based control systems using platforms such as Siemens WinCC, PCS7, or similar Configure and maintain DCS platforms, including Siemens PCS7 and/or DeltaV from Emerson Collaborate with cross-functional teams including process engineering, validation, manufacturing, and quality Troubleshoot and resolve automation-related issues during project execution or manufacturing daily operations Author and review automation documentation including design specifications, FRS,SDS, HDS, URS, FAT, SAT, and validation protocols Implementing minor and major expansion projects on site and changes targeting optimisation as part of the operational support Primary Responsibilities Project Ownership: Accountable for the successful execution of projects from initiation through completion, ensuring all deliverables meet client expectations and regulatory standards. Quality Assurance: Responsible for ensuring that all processes comply with cGMP and other regulatory requirements, thereby safeguarding product quality and patient safety. Client Satisfaction: Ensure high levels of client satisfaction through effective communication, timely updates, and proactive problem-solving. Compliance and Risk Management: Identify and mitigate risks associated with technology transfer, ensuring that all operations are compliant with internal and external guidelines. Develop and validate process maps and models in collaboration with cross-functional teams. Adapt to additional tasks and responsibilities as assigned, demonstrating flexibility and a proactive approach. Education B.Tech/M.Tech in Industrial Process Engineering, Automation Engineering, Instrumentation & Electrical Engineering, Chemical Engineering or related fields. 7-10 years of relevant industry experience in biopharmaceutical automation (process design, commissioning, or manufacturing support) In-depth knowledge of biotech manufacturing processes, with specialization in Upstream automation, not limited to process including software writing and IT & infrastructure Experience with PLC and SCADA/DCS platforms: Siemens WinCC, PCS7, DeltaV, or comparable systems Proficient in batch process control, recipe creation as per ISA/S88 is a must Strong understanding of instrumentation, P&IDs, control strategies, and process control hardware/software integration Knowledge of GAMP5, 21 CFR Part 11 compliance, and other regulatory guidelines Hands-on experience in project executions including qualification phase (IQ/OQ/PQ) and on-floor operations Excellent communication and documentation skills Preferred Attributes Experience with single-use technologies (SUT) and Stainless-Steel technologies in bioprocessing Prior involvement in facility design or greenfield/brownfield projects Experience working with digital plant systems or in digital transformation initiatives in biopharma Exposure to data historians, automation analytics, and real-time monitoring systems Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Pls visit us at https://syngeneintl.com/ to know more about us and what we do. Show more Show less

Strateena is currently seeking a Techno-Functional Consultant at Grade Level 4 with expertise in Oracle EPM to provide support, enhancements, and upgrades for their Oracle EPM Platform. The ideal candidate should possess strong communication skills to effectively engage with business stakeholders, gather requirements, document processes, and offer valuable business insights. In this role, you will be responsible for delivering end-to-end solutions that meet client's business requirements and address business challenges through the utilization of Oracle EPM applications. A robust background in finance business processes and hands-on experience with Oracle EPM Cloud is essential for providing business solutions that minimize the reliance on PaaS solutions. As a Techno-Functional Consultant, you will lead the architecture, solution design, and development for data platforms, business solutions, and proof of concept. You will also collaborate with the ERP team to achieve business objectives and oversee a team of junior developers in a hands-on capacity. Key responsibilities include working closely with end users to understand their processes and needs, translating business requirements into technical specifications for Oracle EPM implementation, customization, and upgrades, as well as providing hands-on support and maintenance for Oracle EPM applications. Additionally, you will design, develop, and implement Oracle EPM solutions and integrations, collaborate with team members to ensure project success, create technical documentation, and deliver end-user training and support. This role is integral to a centralized team focused on building and managing EPM solutions for Strateena's clients, both on cloud and on-premise. You will report to managers, follow milestones, and complete tasks assigned by more experienced analysts and managers. Requirements for this position include a BS/BA Degree in Computer Science, business, or a related field, along with 10+ years of experience as a Techno-Functional Consultant. You should have a strong background in Oracle EPM implementation, maintenance, enhancements, and support, as well as technical proficiency in Oracle EPM tools like HFM, Essbase, Planning, and DRM. Strong analytical, problem-solving, and communication skills are crucial, along with the ability to work effectively in a team environment and manage multiple tasks simultaneously. Additional preferred qualifications include experience with Tableau, strong SQL skills, documentation expertise, and familiarity with GAMP5, GMP, and ITIL service management. Experience in Oracle Fusion is a plus, and participation in multiple Oracle ERP Full Life Cycle Implementation Projects is highly desirable. If you meet these qualifications and are looking for an opportunity to apply your technical expertise and business acumen in a challenging and rewarding environment, we encourage you to apply for this role at Strateena.,

JOB OVERVIEW: To perform and author Computer System Validation activities of GxP Computerized as per defined processes at Corporate IT and across Piramal Pharma sites. KEY STAKEHOLDERS: INTERNAL Business Site / Corporate functions IT Team (e.g. SAP/ Infra / Quality IT / Allied / SAP Basis) KEY STAKEHOLDERS: EXTERNAL IT Vendors IT Contractors/Consultants REPORTING STRUCTURE: Will report to Chief Manager- IT CSV EXPERIENCE: Candidate with 3-6 years of experience in Pharma/Life science domain working knowledge in authoring on Computer System Validation Deliverables, Part 11/Annex 11, Data Integrity Work experience in Pharmaceutical Sector will be desirable SKILLS AND COMPETENCIES Experience in Authoring all CSV deliverables e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. as per V Model for IT projects Experience on validation of any of the enterprise level applications. e.g. Trackwise, Ensur/Documentum, LIMS, LMS, SAP/HANA, Chromatographic, Serialization, etc. Author, review and approval of SOPs, Guidelines/Policies as applicable. To have functional knowledge of Regulatory guidelines, Quality and Manufacturing processes. A team player with good communication skills (verbal & written) KEY ROLES & RESPONSIBILITIES To have thorough understanding, practical approaches for Computer system validation (CSV) 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 infrastructure ((Network, Servers, Cloud, Database) qualification documentation. 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 perform periodic and audit trail review of computerized systems as per defined frequency. To support the initiatives undertaken by Quality eCompliance and CSV team across the Corporate/PEL sites. Perform IT Supplier assessment and ensure compliance of audit observations. To liaise with Site ITC SPOCs for CSV activities and IT Compliance initiatives. To guide and train IT & CSV teams (Corporate & Site) for CSV, Data Integrity and Regulatory Compliance activities. Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) Ability to represent during regulatory audits and can able to perform Corporate & DI Audits of sites. To work along with CSV & Project Manager to ensure project timelines are met. Knowledge Required:- Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV, GAMP 5 (Must) Good knowledge of Data Integrity requirements for Pharma (Must) Experience of working at Pharma Site QC, QA, IT, CSV etc. (Plus) Experience of validation on automation/digitization projects (Plus) Good Verbal and Written communication skills (Must) Good Knowledge on Computer Software Assurance Aware of industry best practices and knowledge about Pharma 4.0 (Plus) Functional knowledge of 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.) (Must) QUALIFICATION: Graduate in Science/Pharmacy/Engineering Post Graduation Science/MBA (Desirable)

Position Summary This role offers a compelling opportunity to work with leading clients in the life sciences and healthcare space, supporting regulatory compliance, governance, and quality system validation initiatives. Youll be part of a dynamic team, driving innovation and ensuring adherence to global standards in regulated environments. Key Responsibilities Regulatory Compliance: Identify and manage regulatory risks to support clients in compliance, governance, and control frameworks. Project Leadership: Lead and coordinate cross-functional teams for new product development, system validations, and quality assurance activities. Process Improvement: Assist clients in developing strategies for process improvements that align with the needs of the quality organization. Validation Expertise: Author validation strategies, protocols, and summary reports. Lead end-to-end computerized system validation (CSV) activities (experience is mandatory ). Plan, manage, and execute IQ, OQ, and PQ activities in accordance with cGMP. Cross-Functional Coordination: Collaborate with R&D, Engineering, Software Development, IT, Manufacturing, and QA teams for successful project execution and training. Documentation & Review: Review and approve validation lifecycle documentation. Identify and resolve validation deviations with appropriate CAPAs. Provide quality review of change requests related to processes, IT infrastructure, equipment, and systems. Project Governance: Manage project updates, escalation closures, and strategic decisions with senior management. Training & Knowledge Transfer: Initiate workshops and training sessions to build competence across teams. About the Team Deloittes Regulatory & Operational Risk Life Sciences & Healthcare (R&OR LSHC) team provides specialized validation services addressing regulatory requirements (GxP, Part 11) and governance controls across people, processes, and technology. Our mission is to help organizations evolve through disruption with strategic resilience and compliance excellence. Required Qualifications & Experience Bachelors degree (or equivalent) 2.5–5 years of experience in the pharmaceutical or medical device industry Strong understanding of quality systems and regulatory compliance Hands-on experience with: Computer system validation (CSV) Software development lifecycle methodologies (GAMP5, Agile, Waterfall) Demonstrated project management skills on medium to large-scale projects Proficiency in identifying risks, analyzing problems, and implementing effective solutions Strong communication and presentation abilities Team-oriented mindset with a collaborative approach Preferred Qualifications Master’s degree in a relevant discipline In-depth knowledge of pharma and medical device quality systems Understanding of design controls , manufacturing processes , and risk management principles

Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (Infra) Qualification 7) Installation Qualification protocol 8) Operational Qualification 9) Performance Qualification 10) Traceability matrix 11) Validation summary report

Role & responsibilities Position Summary: We are seeking an experienced Quality Engineer (QE) with a strong understanding of Good Manufacturing Practice (GxP) regulations. The ideal candidate will play a key role in ensuring that our products meet the highest quality standards by supporting manufacturing operations and ensuring compliance with regulatory requirements. The role will require a deep understanding of GxP and the ability to drive continuous improvements in quality systems, processes, and product quality. Key Responsibilities: Lead and support GxP compliance activities, ensuring adherence to FDA, EMA, and other regulatory requirements. Develop, implement, and maintain quality engineering procedures, systems, and standards in line with GxP regulations. Provide quality support for the design, development, and manufacturing of products to ensure compliance with internal quality standards and external regulatory requirements. Lead investigations into non-conformances, deviations, and CAPAs (Corrective and Preventive Actions), ensuring timely resolution and compliance with GxP documentation requirements. Perform risk assessments and implement risk mitigation strategies related to product quality and GxP compliance. Conduct internal audits and collaborate with external auditors to ensure GxP compliance. Review and approve GxP-related documents, such as batch records, validation protocols, and change control documents. Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs, etc.) to identify and resolve quality issues and drive continuous improvement initiatives. Provide training and guidance to team members on GxP requirements and quality-related topics. Support validation activities (e.g., process validation, equipment qualification) to ensure GxP-compliant operations. Assist with regulatory submissions, ensuring that GxP documentation is complete and accurate. Qualifications: Bachelors degree in Engineering, Life Sciences, or related field. years of experience in quality engineering or quality assurance, with a focus on GxP compliance. Strong knowledge of GxP regulations (FDA, EMA, ICH, etc.) and industry standards (ISO, ICH Q10, etc.). Experience with quality systems management, CAPA, investigations, and auditing. Familiarity with software/tools for GxP documentation and quality management systems (e.g., SAP, TrackWise, Veeva). Strong problem-solving skills and the ability to lead cross-functional teams to resolve quality issues. Excellent communication skills, both written and verbal. Detail-oriented with strong organizational skills.

Bachelors degree in information technology, Computer Science, Engineering, or a related field. Minimum 3-5 years of experience in IT administration, preferably within a manufacturing or industrial environment. Strong knowledge of manufacturing IT systems such as MES, ERP, SCADA, PLCs, and industrial network protocols (e.g., OPC, Modbus, Profibus). Strong Knowledge of CSV Qualification documentation. Strong Knowledge of Regulatory guild line like 21CFR11, GAMP5, EU Annex11. Must know about CSV document work flow. Experience with database management, data analytics, and reporting tools. Familiarity with cybersecurity practices relevant to manufacturing environments (e.g., ICS/SCADA security, NIST, ISO 27001). Excellent problem-solving skills and the ability to troubleshoot complex technical issues under pressure. Demonstrated ability to communicate technical information clearly to non-technical users. Strong organizational skills and attention to detail. Ability to work collaboratively in cross-functional teams and adapt to changing priorities. Experience with Industry 4.0 technologies such as IoT, cloud computing, and machine learning in a manufacturing context. Must aware about the backup and restoration process of IT and OT Devices. Knowledge of Lean manufacturing, Six Sigma, or other process improvement methodologies. Prior experience with project management tools and methodologies. Capability to lead small to medium-sized IT projects from conception to completion.