We Are Hiring Officer: Purchase & Logistics Company: GreenSignal Bio Pharma Pvt. Ltd. Role: Officer Purchase Location: Kodambakkam , Chennai Industry: Pharmaceuticals / Biopharmaceuticals / Vaccine Manufacturing About the Company: GreenSignal Bio Pharma Pvt. Ltd. is a leading manufacturer of vaccines and sterile pharmaceutical products. We are committed to delivering high-quality, life-saving solutions globally. Join our team and contribute to ensuring Wellness for All through innovation and operational excellence. Job Description: We are seeking a proactive and detail-oriented Officer – Purchase & Logistics with experience in pharmaceutical or sterile manufacturing environments. The ideal candidate will have strong expertise in supply chain operations, vendor coordination, and regulatory compliance relevant to vaccine manufacturing and cold chain management. Key Responsibilities: Manage vendor development , evaluation, and negotiations for materials and services Coordinate import/export operations , including documentation and customs clearance Ensure compliance with GDP (Good Distribution Practices) and cold chain protocols Conduct supplier audits , manage statutory requirements, and ensure regulatory compliance Optimize procurement costs , support budget planning, and manage inventory Use SAP (SD & MM modules) for purchase, stock, and vendor management (Mandatory) Prepare regular MIS reports and dashboards using MS Office (Excel, Word, PowerPoint) Collaborate with cross-functional teams for seamless logistics and material flow Monitor lead times and ensure timely delivery of critical materials Qualifications: Degree in any discipline; MBA in Logistics / Supply Chain Management preferred 3–8 years of relevant experience in pharmaceutical, vaccine, or sterile manufacturing Sound understanding of cold chain logistics , GDP guidelines , and global sourcing Desired Candidate Profile: Strong communication and negotiation skills Hands-on experience with SAP – SD & MM modules Familiar with pharmaceutical regulatory environments and compliance standards Ability to work under pressure and manage multiple vendors and shipments simultaneously Detail-oriented with strong analytical and reporting skills How to Apply: Email your resume to: hr@gsbpl.com Contact / WhatsApp: +91 8778926365 Visit us: www.gsbpl.com Why Join Us? At GreenSignal Bio Pharma, we offer a dynamic work culture focused on innovation, quality, and professional growth. Be part of a mission-driven company making a real difference in global health.
Were Hiring: Stores & Warehouse Executive / Assistant Location: Gummidipoondi, Tamil Nadu Company: GreenSignal Bio Pharma Pvt. Ltd. Industry: Vaccine Manufacturing | Pharmaceutical | Biotechnology GreenSignal Bio Pharma Pvt. Ltd., a leading vaccine manufacturing company, is seeking enthusiastic and detail-oriented professionals to join our Stores & Warehouse team at our Gummidipoondi facility. Key Responsibilities: Manage the receipt, storage, and dispatch of raw materials, consumables, and cold chain products Maintain batch-wise inventory records and ensure traceability Ensure compliance with GMP , GDP , and cold chain protocols Coordinate closely with QA, Production, and Procurement departments Conduct routine stock audits and maintain accurate documentation for regulatory purposes Follow strict hygiene and material handling practices suited for biological substances Qualifications & Requirements: Education: B.Pharm or Any Other Degree Experience: 02 years (Freshers welcome) Preferred: Prior experience in pharmaceutical or vaccine manufacturing stores/warehouse Technical Skills: Hands-on experience with SAP , ERP systems , and inventory management software Familiarity with cold storage handling and regulated storage conditions Good command of MS Excel for reporting and stock analysis Understanding of GMP-compliant documentation and material handling SOPs What Were Looking For: Detail-oriented and highly organized individuals Strong understanding of quality and regulatory practices Willingness to work in a fast-paced, high-compliance environment Team player with good communication skills Interested? Apply Now! Email: hr@gsbpl.com Mobile: 87789 26365 Be a part of a team that's making a difference in global health through vaccine innovation.
Job Title: Manager - Regulatory Affairs / Quality Assurance Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 10-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: Bachelors or Masters in Pharmacy M.Sc in Biotechnology, Microbiology, or a related field Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager QA / Regulatory Affairs , you will play a pivotal role in ensuring that our vaccine , injectable , and sterile pharmaceutical products meet global regulatory requirements and quality assurance (QA) standards. You will oversee regulatory strategies, regulatory audits, and the management of Quality Management Systems (QMS) to ensure our products comply with industry-specific standards. This role demands extensive experience in regulatory affairs , particularly within the vaccine and sterile manufacturing domains, including handling CDSCO , EU GMP audits, and other regulatory matters. Key Responsibilities: 1. Regulatory Strategy & Compliance: Develop and execute regulatory strategies to ensure compliance with global standards for vaccine , injectable , and sterile products . Maintain a strong understanding of global regulatory requirements, including FDA , EMA , WHO , and local regulations like CDSCO to guide product approvals and market entry. Ensure alignment of product development and manufacturing processes with Good Manufacturing Practices (GMP) , Good Laboratory Practices (GLP) , and other relevant GxP standards. 2.Audit & Inspection Management: Coordinate and manage regulatory audits (e.g., CDSCO , EU GMP ) for vaccine , injectable , and sterile products, ensuring full compliance and readiness across all departments. Lead the preparation for regulatory inspections related to CDSCO and EU GMP , working closely with relevant teams to ensure effective corrective actions and continuous compliance. Manage responses to audit findings and ensure the implementation of corrective actions in line with industry standards. 3.Quality Management System (QMS): Oversee the implementation and management of the Quality Management System (QMS) to ensure product quality and regulatory compliance. Lead the development and review of Standard Operating Procedures (SOPs) , ensuring that they align with current regulatory requirements for vaccine and sterile product manufacturing. Monitor and ensure compliance with the QMS framework across all departments to maintain consistent product quality. 4. Regulatory Submissions & Documentation: Oversee the preparation, compilation, and submission of regulatory dossiers and eCTD documents to regulatory bodies (e.g., FDA , EMA , CDSCO ). Ensure that all required documentation and records are properly maintained and comply with regulatory standards, ensuring smooth regulatory approvals for vaccine , injectable , and sterile products . 5.Risk Assessment & Mitigation: Conduct regulatory risk assessments to identify potential issues related to product development, manufacturing, and compliance. Develop and implement risk mitigation strategies to ensure uninterrupted production and compliance with regulatory standards. 6.Cross-Functional Collaboration: Collaborate with internal teams such as R&D, Production, and Quality Control to ensure regulatory compliance throughout the product lifecycle, from development to post-market surveillance. Provide regulatory guidance and training to cross-functional teams, ensuring awareness of applicable QA practices and regulatory requirements . 7.Corrective and Preventive Actions (CAPA): Lead the implementation of Corrective and Preventive Actions (CAPA) to address audit findings, non-conformities, and deviations, ensuring continuous improvement in compliance and quality practices. Key Skills and Competencies: Expert Knowledge of Regulatory Guidelines Regulatory Submissions & Documentation Expertise Audit & Inspection Management Quality Management System (QMS) Oversight Risk Management & Mitigation Strong Leadership & Project Management Corrective & Preventive Action (CAPA) Implementation Excellent Communication Skills About GreenSignal Bio Pharma Pvt Ltd GreenSignal Bio Pharma Pvt Ltd is a leading pharmaceutical company specializing in vaccine , injectable , and sterile products . Our commitment to quality, compliance, and innovation has made us a trusted partner in the healthcare industry. We are looking for experienced professionals to contribute to advancing our vaccine and biologics portfolio while adhering to the highest regulatory standards. For more information, please visit: www.gsbpl.com How to Apply: Interested candidates can apply via email at: hr@gsbpl.com For inquiries, please contact us at: +91 8778926365 Join Our Team and make a significant impact in the vaccine and sterile product industries!
Company : GreenSignal Bio Pharma Pvt. Ltd. Role : Logistics Executive Work Location : Kodambakkam, Chennai Industry : Biopharmaceuticals / Vaccine Manufacturing About the Company : GreenSignal Bio Pharma Pvt. Ltd. is at the forefront of vaccine development and manufacturing, delivering critical life-saving solutions globally. We are committed to advancing public health through innovation, operational excellence, and the highest quality standards. Job Description : We are looking for a Logistics Executive with a strong background in pharmaceutical logistics , particularly in the handling and distribution of vaccines. The ideal candidate will have expertise in managing cold chain logistics, ensuring timely delivery, and collaborating effectively with cross-functional teams to ensure the smooth flow of materials. Key Responsibilities : Oversee and manage logistics operations, including transportation, warehousing, and distribution of vaccine products. Manage export-import documentation and optimize global shipments, customs clearance, and logistics processes. Coordinate with carriers, agents, and trucking companies to arrange bookings and ensure on-time deliveries. Prepare import and export documentation for a variety of goods and shipments. Coordinate cold chain logistics, ensuring strict compliance with temperature-controlled transport and storage protocols. Liaise with internal teams and external vendors to ensure timely delivery and proper handling of materials in compliance with regulatory standards. Monitor inventory levels to ensure timely replenishment and optimal stock management across warehouses. Ensure documentation and regulatory compliance, including customs clearance and import/export requirements. Collaborate with procurement, production, and quality control teams to meet delivery schedules and minimize disruptions. Manage logistics documentation, including shipping invoices, customs paperwork, and delivery receipts. Generate and analyse logistics performance reports, identifying areas for improvement and cost optimization. Resolve any logistics-related issues or delays, taking immediate corrective actions. Qualifications : Bachelor's degree in Logistics, Supply Chain Management, or a related field; additional certifications in logistics management are a plus. 1-5 years of experience in pharmaceutical logistics or vaccine manufacturing. Strong knowledge of cold chain management and regulatory compliance (Good Distribution Practices, temperature monitoring systems). Desired Candidate Profile : Detail-oriented with excellent organizational and problem-solving skills . Strong communication and negotiation skills to work with suppliers, vendors, and cross-functional teams. Hands-on experience with logistics software and inventory management systems. Ability to manage multiple shipments, vendors, and deadlines under pressure. Proficient in using SAP or similar enterprise resource planning (ERP) systems. How to Apply : Send your resume to: hr@gsbpl.com For queries, contact us on: +91 8778926365 Visit our website: www.gsbpl.com Why Join Us? At GreenSignal Bio Pharma, we offer an empowering work environment where innovation, professional development, and quality are at the heart of what we do. Be a part of a mission-driven company that is shaping the future of global healthcare.
The QMS Lead / Head is responsible for establishing, implementing, and maintaining a robust Quality Management System in compliance with USFDA, WHO , and other global regulatory requirements. The role ensures that vaccine manufacturing operations meet applicable GMP standards, inspection expectations, and quality risk management principles Key responsibilities: Lead implementation, maintenance, and continual improvement of the site QMS in alignment with ICH Q10, WHO TRS, and USFDA 21 CFR Parts 210/211/600. Ensure continuous inspection readiness for WHO-PQ , USFDA , EMA , CDSCO , and other regulatory agency audits and Lead preparation of inspection plans, SME readiness, and gap assessments. Drive CAPA effectiveness checks and closure within defined timelines Develop, implement, and maintain the organization's QMS to ensure compliance with standards like ISO/WHO TRS Provide oversight on deviation investigation, OOS/OOT handling aligned with FDA and WHO expectations and ensure changes are adequately risk-assessed using ICH Q9 principles. Plan and execute internal GMP audits across manufacturing, QC, warehouse, and utilities. Prepare and review site quality KPIs : deviations, CAPA performance, complaints, product quality reviews, audit findings. Lead monthly/quarterly Management Review Meetings (MRM). Prepare and present regular reports on quality performance criteria. Oversee corrective and preventive actions to address issues identified during audits and drive a culture of continuous improvement by facilitating quality projects and initiatives across the organization. Ability to lead, motivate, and manage cross-functional teams, and develop staff through coaching and training. Strong skills in data analysis, identifying root causes, and developing effective solutions, often using statistical analysis or specialized software (Ample Logics/eLog/LIMS) and excellent written and verbal communication to articulate quality goals, write reports, and interact with at all levels. Familiarity with industry-specific tools (e.g., ISO standards, SAP systems, statistical software like Minitab and quality management methodologies). Required Qualifications: B. Tech / M. Tech / M.Sc. in Biotechnology, Microbiology, Biochemistry, Life Sciences, or related fields. Bachelor /Master of Pharmacy/ B. Tech Biotech/Pharmaceutical technology Experience 815 years in Pharmaceutical/Biologics/Vaccine manufacturing QA/QMS roles. Minimum 3–5 years handling WHO-PQ and USFDA inspection preparedness directly. Technical Skills: Strong knowledge of: WHO Vaccines GMP requirements USFDA 21 CFR 210/211 USFDA 21 CFR 600 series (Biologics) ICH Q7, Q8, Q9, Q10 Data Integrity (ALCOA+) Experience in QMS digital systems (Track Wise/Ample logic/eLOG,) Thorough knowledge of sterile manufacturing, aseptic operations, and vaccine-specific processe
Job Title: HVAC Operator / Engineer / Executive Company: GreenSignal Bio Pharma Pvt Ltd Industry :Pharma Vaccine Manufacturing Location: Gummidipoondi, Chennai Employment Type: Full-Time Experience Required: 3 to 8 years (Pharma HVAC experience preferred) Education: Diploma / Bachelors / Masters in Mechanical, Electrical, HVAC, or related fields Job Overview: We are seeking skilled and motivated HVAC Operators and Engineers to support our pharmaceutical vaccine manufacturing facility. This role involves operating, maintaining, and troubleshooting cleanroom HVAC systems in a GMP-compliant environment. Candidates with experience in HVAC systems within regulated pharma or cleanroom setups are highly encouraged to apply. Key Responsibilities: HVAC System Operation & Maintenance Operate and maintain AHUs, chillers, cooling towers , ventilation systems, and ducting. Perform preventive and corrective maintenance of HVAC equipment. Troubleshoot mechanical, electrical, and airflow-related HVAC issues. Cleanroom & Contamination Control Monitor and maintain temperature, humidity , and differential pressures per ISO 14644 and GMP guidelines. Maintain HEPA filters , air handling performance, and pressure balance. Ensure cleanliness and performance of air showers, laminar flow units, and clean zones. Airflow & Ventilation Systems Manage ducting, dampers, diffusers, exhaust systems, and fume extraction setups. Support cleanroom operations by ensuring optimal airflow and pressure balance . Chiller & Refrigeration Systems Support the operation and upkeep of air-cooled and water-cooled chillers , cooling towers, and compressors. Follow energy efficiency and refrigerant handling guidelines. Documentation & Compliance Maintain service logs, maintenance records, and HVAC-related GMP documentation. Participate in HVAC calibration and validation activities. Support internal and external audits and inspections . Building Management System (BMS) Operate HVAC systems via BMS for real-time performance monitoring . Log critical HVAC parameters and assist with system troubleshooting. Key Skills & Competencies: Understanding of HVAC systems in pharma/cleanroom environments HVAC Operation, AHU Monitoring, Cleanroom HVAC, BMS, EMS, GMP Compliance, Chiller Plant Operation, DP/RH/Temp Monitoring, Pharma HVAC. Familiarity with GMP, ISO 14644, ASHRAE standards Strong problem-solving and troubleshooting skills Experience in preventive maintenance and compliance documentation Ability to work in high-regulation, fast-paced environments Good communication and teamwork abilities Must have Skills: HVAC, AHU, BMS/EMS, GMP Documentation, Chiller Operations, DP/RH/Temp Monitoring Why Join GSBPL? Be part of a vaccine manufacturing leader Gain specialized experience in pharma HVAC operations Growth opportunities with a supportive team Competitive salary and benefits About the Company: GreenSignal Bio Pharma Pvt Ltd is a WHO-prequalified, leading vaccine manufacturer in India. We specialize in producing life-saving vaccines like BCG, serving global health needs with a strong commitment to quality, innovation, and regulatory excellence. Learn more: www.gsbpl.com Apply: hr@gsbpl.com Contact: +91 8778926365
Job Title: HR & IR Officer / Executive / Sr. Executive Department: Human Resources & Industrial Relations Location: Gummidipoondi, Thiruvallur, Chennai, Tamil Nadu Experience: 2 to 5 Years Industry: Biotechnology, Pharmaceutical & Vaccine Manufacturing About GreenSignal Bio Pharma Pvt Ltd: GreenSignal Bio Pharma Pvt Ltd is a leader in the biotechnology, pharmaceutical, and vaccine manufacturing sectors, dedicated to providing high-quality healthcare solutions. We are seeking a skilled HR & IR Officer/Executive/Sr. Executive to support a positive work environment while ensuring compliance with industry regulations and labor laws. Key Responsibilities: Time Office Management: Oversee attendance, leave management, and shift schedules for employees. Recruitment & Onboarding: Manage recruitment, interviewing, and onboarding for new employees, ensuring a seamless induction. Vendor Management & CCTV Monitoring: Coordinate with vendors for HR services and monitor workplace security systems. Contract Labour Management: Ensure compliance with legal and statutory norms related to contract labor. Government Liaison Activities: Interface with government authorities for compliance with labor laws, licenses, and permits. HRMIS Maintenance: Keep HR Management Information System (HRMIS) updated and accurate for reporting purposes. Vendor Bill Processing & Verification: Process vendor bills related to HR services, ensuring accuracy and timeliness. Official Correspondence & Documentation: Prepare and manage HR communications and documentation. Employee Welfare, Safety & Canteen Administration: Manage welfare programs, ensure safety measures are followed, and oversee canteen administration. Periodic HR Reports: Provide HR reports to senior management on various workforce metrics. Factory Security Management: Ensure proper security arrangements are in place at the manufacturing site. EHS Management: Work with EHS teams to ensure compliance with environmental, health, and safety standards. Employee Background Verification: Conduct background checks to ensure employee integrity. Employee Performance Appraisals: Facilitate the performance appraisal process, ensuring evaluations are completed on time. Updating HR & Admin SOPs: Regularly review and update standard operating procedures (SOPs) for the HR and Admin departments. Payroll Management: Oversee payroll processing, including salary computation and timely disbursement. Employee Engagement: Develop initiatives to improve employee morale and productivity. Industrial Relations: Address and manage industrial relations issues, fostering smooth communication between management and employees. Committee & Union Management: Handle interactions with employee committees and unions, ensuring compliance with agreements. Industrial Safety Management: Implement and maintain safety measures to ensure a secure working environment. Qualifications: Education: Bachelor's degree in HR, Personnel Management, Business Administration, or a related field. A Master's degree (MBA in HR) is a plus. Experience: Minimum 2 years of experience in HR and Industrial Relations within a pharmaceutical/biotech/vaccine manufacturing environment. Skills: Proficiency in MS Office (Excel, Word, PowerPoint), experience with HRMIS, and strong knowledge of labor laws and industrial relations. Key Competencies: Strong analytical skills Excellent communication and interpersonal skills Problem-solving and conflict management abilities Attention to detail and organizational skills Ability to multitask and manage time effectively Why Join Us? Career Growth: Opportunities for professional development in a dynamic environment. Competitive Salary & Benefits: Attractive salary package and additional perks. Work-Life Balance: A commitment to fostering a balanced work environment. Impactful Work: Contribute to innovative solutions in the pharmaceutical and biotechnology industries. Application Process: Interested candidates can send their resume to hr@gsbpl.com & WhatsApp to 8778926365 with the subject line Application for HR & IR Officer/Executive/Sr. Executive.
Location: Kodambakkam / Gummidipoondi Department: Pharmacovigilance Position: Pharmacovigilance (PV) Associate Job Type: Full-time Role Overview : The Pharmacovigilance (PV) Associate is responsible for the timely and accurate processing of adverse event reports, ensuring compliance with global and local regulatory requirements for drug safety. Key Job Responsibilities 1. Case Management & Processing Receive and Triage: Intake and prioritize all incoming adverse event (AE) reports from various sources (e.g., spontaneous reports, literature, clinical trials, and regulatory authorities). Data Entry: Perform detailed and accurate data entry of AE reports ensuring complete case documentation. Case Narrative: Write clear, concise, and medically accurate case narratives that summarize. Follow-up: Initiate and manage follow-up queries with reporters (HCPs, patients) to obtain missing or clarifying information necessary for case completion. 2. Regulatory Compliance & Reporting Submission Timeliness: Ensure all expedited (e.g., 7-day, 15-day) and aggregate safety reports are processed and prepared for submission according to global and local regulatory timelines. Perform thorough quality checks on processed cases to ensure data integrity, accuracy, and adherence to company SOPs and regulatory standards. Reconciliation: Assist in the reconciliation of safety data with other departments (e.g., Quality Assurance) to ensure all adverse event reports have been captured. 3. Documentation & System Maintenance SOP Preparation: Follow Standard Operating Procedures (SOPs) and work instructions. Documentation: Maintain comprehensive and organized documentation for all case processing activities, including source documents and follow-up attempts. Required Qualifications and Skills Education: A Bachelor's degree in a life science, pharmacy (B. Pharm/M. Pharm), nursing (BSc/MSc), or other health-related field is required. Experience: Fresher or +1 year of experience in Pharmacovigilance/Drug Safety, Clinical Research, or a related regulatory environment is preferred. Knowledge: Foundational knowledge of global PV regulations (e.g., ICH guidelines, FDA, EMA). Core Competencies: Strong attention to detail, excellent organizational and communication (written and verbal) skills, and the ability to work effectively. GreenSignal Bio Pharma Private Limited is an equal opportunity employer committed to diversity and inclusion. We encourage all qualified candidates to apply.
Position: Archival In-charge Vaccine Manufacturing Unit Department: Quality Assurance / Quality Systems Experience Required: 3 – 4 Years (GMP / Pharmaceutical / Biotech / Vaccine domain) Location: Manufacturing Site About the Role Experienced Archival In-charge to manage GxP documentation and record control in a regulatory compliant vaccine manufacturing environment. The role ensures readiness for WHO, FDA and national regulatory audits by maintaining integrity, traceability, and secure storage of critical records. Key Responsibilities Document & Record Control Receive, verify, classify, and archive batch records, QC data, validation documents, calibration/qualification records and supporting GMP documentation. Maintain document indexing, master archive registers and access logs. Control issuance, retrieval and tracking of documents requested by departments and auditors. Archival Room & Facility Management Maintain archive room conditions as per regulatory expectations (restricted access, temperature/humidity control, pest control). Periodic inspection of archived files for condition, completeness and traceability. Ensure segregation of active, semi-active, inactive records and disposal files. Regulatory & Audit Readiness Provide archived records during internal and external audits. Ensure documentation complies with regulatory requirements. Verify adherence to defined record retention timelines. Electronic Document Management Assist in scanning, indexing and digital storage of documents in EDMS. Support user access control, retrieval, backup validation and data migration activities. SOPs, Training & Compliance Prepare/update SOPs related to archiving and document control. Train departments on record submission, documentation practices and archival requirements. Record Disposal & Security Coordinate secure destruction of expired records as per retention policy. Maintain destruction logs and confidentiality. Qualifications & Experience Education: B.Sc / M.Sc / B.Pharm / M.Pharm (Life Sciences preferred). Experience: 3–4 years in pharmaceutical / vaccine / biotech documentation or QA archival management. Knowledge of GMP principles and ALCOA+ documentation compliance. Skills & Competencies Strong record management skills Good coordination, tracking and retrieval discipline Familiarity with GxP expectations of vaccine manufacturing Working knowledge of MS Office / EDMS Attention to detail, confidentiality, accountability
The IT Manager is responsible for overseeing the design, implementation, validation, and maintenance of all IT systems supporting pharmaceutical/biotech operations. This includes GMP IT infrastructure, data integrity compliance, automation interfaces, SAP/LIMS systems/CCTV/Ample logic, cybersecurity, and ensuring adherence to regulatory requirements such as 21 CFR Part 11, USFDA, WHO, and GAMP 5 requirements. Key responsibilities: Manage and maintain IT infrastructure: servers, networks, data centres, backup systems, and cloud services and ensure high availability of systems supporting manufacturing, QC, warehouse. Administer SAP, LIMS, Ample logic (QMS) DMS, and other validated systems. Coordinate with automation/engineering teams for integration of SCADA, PLC, BMS, EMS with IT networks (GMP segregated networks). Ensure all GMP-related IT systems comply with 21 CFR Part 11, Annex 11, Data Integrity ALCOA+ , and GAMP 5 V-model validation. Lead CSV activities: URS, FS, DS, IQ, OQ, PQ, risk assessments, and periodic review. Implement and maintain audit trails, user access controls, Data backup/restore, and disaster recovery procedures and Support regulatory audits (WHO /CDSCO) and respond to IT-related queries or observations. Establish IT SOPs, policies, and governance framework for GMP and non-GMP areas and Manage IT service desk. Provide support for end-users in production, QC, QA, Purchase, Logistics, HR, and finance and implementation of new IT systems (SAP, LIMS, eQMS). Work with QA for system validation, change control, and deviation handling, with Production/Engineering for network connectivity of equipment and Support QC for analytical instrument connectivity Required Qualifications: Bachelors/Master’s degree in IT, Computer Science, or related fields with 8–10 years of IT experience, with minimum 5 years in pharmaceutical/biotech/GMP regulated environments. Strong knowledge of: 21 CFR Part 11, Annex 11 Data Integrity ALCOA+ GAMP 5 guidelines/CSV (Computer System Validation) Network and cybersecurity Key Skills Strong leadership & people management. Project management skills. Understanding of pharma manufacturing process flows. Excellent troubleshooting and analytical skills. Good communication and coordination ability with cross-functional teams.