231 Gxp Jobs - Page 3

Job Location: Bangalore Qualification: Diploma or Degree in Engineering Experience: 2-4 years with Pharma Background Work profile: Plant IT operations Pharma and Biotech companies Installation of OS and application-level critical updates, Service packs, and security patches on workstations. Performance monitoring of all Servers, Desktops, and Networking devices. Installation and troubleshooting of operating systems and software, ensuring efficient deployment and resolution of issues. Applying the OS patches and upgraded administrative tools, maintaining the latest system updates and utilities for optimal performance and security. Remote support to end-users for enterprise-level applications,...

Computer System Validation (CSV) Exp. :- 3-9 yrs Location :- Pune Work youll do As a part of our Technology & Transformation team, Youll: Support on IT quality systems framework design and implementation Managing the reviews and assessments for IT quality Assist in Computer System Validation (CSV) compliance of GxP processes for pharmaceutical companies or experience on quality compliance services for global consumer health care, medical devices, and pharmaceutical companies GxP Business process review Development of integrated GxP and IT compliance Standard operating procedures and guidelines GxP and IT compliance assessment Define the Validation strategy of IT Software and Systems Actively...

Dear Candidate, Greetings of the Days!! Qualification:- BE or B-Tech Computer sciences. Exp:-5 Years to 10 Years. Salary :- Depends on Candidate Skills and Competency Mapping. Location:-Ahmedabad Job Description:- 1.IT Digital Operations:-Managing Automation, Cloud Services, and Overall IT Work Flow. 2..IT-Infrastructure: Overseeing Data Centre, Physical Servers, VM servers, File server, Network devices, Firewall, Antivirus Crowd Strike, Deep Security, AD, Group policy, Data backup Agents Actifio/Netveritas/Veem Agent/ECM Agilent tool, software systems, and security frameworks for reliable IT performance. 3.Leading IT-CSV Role (Computer System Validation): Overseeing validation activities fo...

Roles and Responsibilities Manage IT infrastructure, including servers, storage, network devices, and virtualization platforms (VMware). Ensure compliance with regulatory requirements such as GXP/GMP/21 CFR Part 11 through documentation and implementation of controls. Develop and maintain CSVs (Computer System Validation) protocols for new equipment installations or upgrades. Collaborate with cross-functional teams to identify opportunities for process improvements and implement changes using tools like Anaplan. Provide technical support for IT systems, troubleshooting issues related to hardware failures or software malfunctions.

• IT Infrastructure Management: Overseeing the management of IT and OT infrastructure, including hardware, software, networks, and data centers. Ensuring the availability, reliability, and security of IT systems. Ensuring minimal downtime and optimal performance. • System Performance: Ensure the reliability and availability of IT and OT systems and applications critical to manufacturing processes as per business requirements. • Security and Compliance: Ensure IT and OT systems and processes comply with industry regulations and standards, such as FDA, EMA, and GMP. • Disaster Recovery: Develop and maintain disaster recovery and business continuity plans to minimize downtime and data loss in c...

Role & responsibilities Collect samples for analysis from custodian. Processing of sample by using various sample extraction technique (to determine the concentration of analyte). Perform analysis via LCMS. Follow GXP. Sample extraction process using LLE, SPE, PPT. Stability issue handling, derivatization, etc. approach. Receive controlled forms for various activities. Document all linked activities and forms as per SOP. To check documents done by Jr. Analyst/ Fresher. Method development skills Trouble shooting of method Excel and MS Word.

Educational Requirements Master of Pharmacy,Master Of Technology,Bachelor of Pharmacy (Honors),Bachelor Of Science,Bachelor of Engineering,Bachelor Of Technology Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to: 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS...

Handle market complaints received from across the globe. You will be responsible for reviewing the investigation reports received from Novartis sites and Contract Manufacturing Organizations. Collaboration with external Supply organization, Novartis sites, and Country pharma organizations for continuous improvement is essential for this role. As a Specialist - Product Complaints - QOP based in Hyderabad, your key responsibilities will include performing day-to-day activities of processing market complaints assigned as per the relevant SOPs, business matrix, and SLA timelines. You will assist in data collection and reporting of KPIs, support continuous improvement initiatives, manage ad-hoc p...

You will be responsible for managing core IT infrastructure, which includes servers, storage, virtualization, and telephony systems. Your main tasks will involve performing continuous monitoring and proactive/preventive maintenance to ensure smooth operation. Additionally, you will need to quickly identify and resolve hardware/software issues and performance bottlenecks. As part of your role, you will be required to implement infrastructure projects, upgrades, and new tool rollouts. You will also need to conduct regular system reviews to ensure compliance with GMP/GxP systems, contributing to audit readiness and regulatory alignment. Maintaining technical documentation, SOPs, and project rec...

The job involves following departmental Standard Operating Procedures and Work Instructions, completing required training within specified timelines, and auditing System Life Cycle (SLC) activities and documentation. You will be responsible for planning, conducting, and leading global internal facility, system, and process audits, as well as external audits of vendors and suppliers. Additionally, you will participate in client and regulatory visits as a subject matter expert in computerized systems and technology compliance. You will also be involved in authoring and reviewing controlled documents, advising internal business, IT, and QA partners on systems and technology compliance, and lead...

The job is based in Hyderabad/Bangalore/Chennai and at Gramener, you will find a welcoming work environment with diverse colleagues, a clear career path, and ample opportunities for growth and innovation. The company aims to develop a range of easily configurable data applications focused on storytelling for both public and private use. As part of your role, you will be involved in various impactful customer technical data platform projects, taking the lead on strategic initiatives that cover the design, development, and deployment of cutting-edge solutions. Collaboration with platform engineering teams will be key in implementing Data Brick services effectively within the company's infrastr...

As the Strategic and hands-on IT leader responsible for managing multi-site GxP-compliant IT operations and plant infrastructure in a regulated pharmaceutical environment, your role will be pivotal in ensuring uptime, compliance, and driving impactful technology-led business enablement. You will act as the Single Point of Contact (SPOC) for IT for site leadership, maintaining real-time audit readiness, enforcing regulatory-compliant practices, and collaborating with central SAP teams to align plant needs. With 9-14 years of experience in Pharma Plant IT Operations and audit exposure, along with a qualification in B.E. / B.Tech / BCA / BCS or an equivalent qualification, you will be expected ...

Handle market complaints received from across the globe. You will be responsible for reviewing the investigation reports received from the Novartis sites and Contract Manufacturing Organizations. You will collaborate with external Supply organization, Novartis sites, Country pharma organizations for continuous improvement. As a Specialist - Product Complaints - QOP based in Hyderabad, your key responsibilities will include performing day-to-day activities of processing market complaints assigned as per the relevant SOPs, business matrix, and SLA timelines. You will assist in data collection and reporting of KPIs, participate in continuous improvement initiatives, manage ad-hoc projects, and ...

PolyPeptide is on a transformative growth journey expanding globally, investing in new technologies, and increasing our production capacity through major site expansions and strategic projects, As part of this, we are launching a global SAP S/4HANA implementation to modernize and harmonize how we work across sites, systems, and teams This is a greenfield initiative and a truly unique opportunity to join from the very beginning and help build the ERP function that will support PolyPeptides operations for years to come, As the Head of ERP, youll take the lead in shaping and delivering this enterprise-wide ERP foundation Youll be a key player in driving digital transformation across the organiz...

I nviting applications for the role of Principal Consultant CSV Analyst In this role, CSV Analyst will prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution. Responsibilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met Evaluate proposed changes to validated computer systems and recommend level of validation activities required Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop CFR Part 11 computer systems validation plans, qualifications test p...

Seeking a CSV Consultant to work on a variety of validation projects including manufacturing systems, lab systems, risk assessments, etc. Some of the work may be done remotely, some at client sites and others at one of our offices. Immediate start date Job Responsibilities: Responsible for the Computer System Validation processes of the company Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11) Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule Lead system qualification efforts and be the primary client contact for coordinating work, repo...

Job Role: Supplier Quality Engineer Duration: 3 months contract Top 3 skills are: Experience with maintaining supplier qualification documentation within GxP systems Experience in creating and maintaining data reports for Supplier Quality function Proficient in Microsoft Excel. Requirements: Minimum 3 years of work experience, preferably in Quality within Pharmaceutical, Life Sciences, Medical Devices, or similar industry Bachelor's degree required Data administrative support for the Global Supplier Quality team including: Maintain weekly Supplier Quality data report in SharePoint Create and/or maintain Supplier Quality reports including monthly KPI bowler, quarterly PO/QSL report, etc. in S...

GxP, GLP, regulatory environments Support Analyst Role: Support Analyst / Application Administrator We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. Key Responsibilities: Act as SME for assigned applications supporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validat...

The Technical Architect will have to be execution-focused, supporting the full implementation lifecycle, from scoping to deployment in an evolving ecosystem consisting of clients and partners. You will be responsible for successfully solutioning the enterprise application E2E, designing and building the Salesforce Industry-specific Life Sciences, Health industry solutions. As a Technical Architect, you will become a deep product expert with Industry Salesforce Life Sciences Cloud (including Health Cloud) applications, and work closely with our sales and delivery teams to ensure customer success. You will lead the technical design and implementation of Salesforce solutions, ensuring complianc...

As a Solution Architect-SAP Production Planning at Percipere, you will be responsible for designing, building, and optimizing end-to-end SAP Manufacturing Processes for our customers" enterprise. You will lead large-scale transformation projects in the Manufacturing Workstream, leveraging your experience, including PP object data migration experience in S/4 HANA. Conducting systematic client workshops to drive and derive key design decisions with industry best practice recommendations will be a crucial part of your role. In this position, you will lead the engagement efforts at different stages, from problem definition to diagnosis, solution design, development, and deployment in large S/4 H...

Alkem Laboratories Limited is an Indian multinational pharmaceutical company based in Mumbai, specializing in the manufacturing and distribution of pharmaceutical generics, formulations, and nutraceuticals across India and over 50 countries globally. Renowned for its top-tier pharmaceutical brands like Clavam, Pan, Pan-D, and Taxim-O, Alkem has consistently secured a position among India's top five pharmaceutical companies. As the IT Business Partner for SCM & Logistics at Alkem, your primary role is to serve as a strategic technology advisor, ensuring that IT solutions are aligned with the company's business objectives for the Supply Chain and Logistics functions. Your responsibilities incl...

Follow applicable departmental Standard Operating Procedures and Work Instructions. Complete required training according to required timelines. Audits System Life Cycle (SLC) activities and documentation. Plan, conduct, and lead global internal facility, system, and process audits. Plan, conduct, and lead external audits of vendors and suppliers. Participates in client and regulatory visits as the subject matter expert in the field of computerized systems and technology compliance. Author and review controlled documents including but not limited to SOPs and policies. Advises internal business, IT, and QA partners on systems and technology compliance. Leads and actively contributes to process...

Execution of IQ, OQ and PQ for new equipment, facility & utility system, report preparation and maintenance of record. Execution of Periodic performance verification activities for equipments, facility, utilities and its report preparation. Review Initial qualification master document like URS, GxP assessment, DQ, FAT, SAT, IQ, OQ, PQ and PPV of EFU system and all executed report. Handling of departmental QMS activity through track wise software, discrepancy / deficiency activity compliance of observation, summary preparation for regulatory submission. Qualification and Periodic performance verification activity execution, compilation, review of reports [Filter integrity test (PAO), air velo...

This role is responsible for managing the external vendor and partner engagements, as well as product and program management and communication efforts for the Technology & Systems team of the Patient Safety and Pharmacovigilance (PS&PV) function This role ensures the successful execution of programs and operations of technology products in line with strategic and operational goals and maintains effective collaboration with external partners as well as with internal stakeholders Major accountabilities: Develop and maintain strong relationships with key strategic partners and vendors for Technology delivery for PS&PV Advise function leadership on best practices for supplier engagement and stra...

Job Summary: We are seeking a meticulous and detail-oriented Quality Checker to join our packaging artwork team. The role requires thorough experience in reviewing packaging artworks for compliance, consistency, and accuracy. The ideal candidate should be familiar with Adobe Creative Suite tools and artwork validation workflows in regulated industries like pharmaceutical or CPG/FMCG domains. Role & responsibilities Verify packaging artwork files against technical briefs, regulatory standards, and brand guidelines. Check alignment, font consistency, spelling, and layout accuracy in Illustrator and InDesign files. Compare artwork revisions using visual comparison tools or side-by-side manual m...