Frontend Developer (UI Developer) We are seeking a skilled Front-End Developer to design and develop user interfaces for an internal web-based application used by our Information Security team. The ideal candidate will have a strong background in modern web development, a passion for creating seamless user experiences, and the ability to collaborate with back-end developers, security architects, and other internal stakeholders. This role requires creativity, attention to detail, and a commitment to building secure, efficient, and visually appealing interfaces.Design, develop, and maintain responsive and interactive front-end interfaces using Angular framework.Collaborate with back-end developers to integrate APIs and ensure smooth data flow between the front end and server-side systems.Translate wireframes, mockups, and user requirements into clean, maintainable, and reusable code.Implement intuitive visualizations, dashboards, and workflows to enhance user interaction and productivity.Work closely with the Information Security team to ensure front-end solutions align with organizational security standards and best practices.Participate in code reviews, testing, and debugging to maintain high-quality deliverables. Qualifications:Bachelor's degree in computer science, engineering, or a related field (or equivalent experience).3+ years of experience in front-end development using Angular framework, with a focus on building web applications.Proficiency in HTML, CSS, JavaScriptStrong understanding of responsive design principles and cross-browser compatibility.Familiarity with RESTful APIs and integrating with back-end services.Knowledge of version control systems (e.g., Git).Excellent problem-solving skills and attention to detail.Ability to work collaboratively in a team environment and communicate effectively with technical and non-technical stakeholders. Preferred Skills:Experience with TypeScript or other statically typed languages.Familiarity with data visualization libraries (e.g., D3.js, Chart.js).Understanding of security best practices in web development (e.g., XSS prevention, secure data handling).Previous experience working on internal tools or applications for technical teams.Experience with Backend Development is a plus.
Company Overview: Our client is a leading provider of Pharmacovigilance (PV) Technology Solutions. They bring together Life sciences domain expertise, third party system knowledge and advanced technology to develop well-defined solutions, which address challenges across PV functions. Data Scientist – AI/ML Developer We are seeking an Data Scientist (AI/ML Developer) with deep technical expertise and a strong ability to design and develop AI/ML solutions . The ideal candidate will have experience defining AI strategies, evaluating multiple approaches to problem-solving, and guiding teams in implementing scalable and efficient solutions. Required Skills & Experience: Expertise in AI/ML Solutioning : Proven ability to design and architect AI/ML applications beyond model development. Hugging Face & Model Fine-tuning : Extensive experience with Hugging Face Transformers, fine-tuning pre-trained models for NLP and OCR tasks. AI/ML Infrastructure : Deep understanding of model serving APIs, cloud-based AI deployments, and MLOps best practices. Vector Search & Knowledge Graphs : Experience with vector search engines, semantic search, and knowledge representation techniques. Database & Storage Systems : Strong understanding of relational (Postgres, MySQL)databases for AI applications. Strategic Mindset : Ability to balance innovation with technical feasibility and business impact. Show more Show less
About Client: Our client brings together Pharmacovigilance expertise, third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across Medical Affairs, Regulatory and Safety functions. Our client solutions free up responsible personnel within Pharma companies to execute their stated responsibilities while staying true to the laws of the land, and ultimately achieving a balance between compliance and managing business risks. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable them to serve large and small organizations, both in developed and emerging markets. Our client is committed to bringing focus to things that really matter for advancing patient outcomes. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable us to serve large and small organizations, both in developed and emerging markets. Position Overview: Position: Argus Configuration Specialist Location: Onsite, Noida, India Experience: 3-8 years • Should have good understanding of the Pharmacovigilance/ Health Care domain. • Should have excellent knowledge of Oracle Argus Safety or other PV/Safety systems. • Should have experience in installing/configuration/validation of Argus Safety and customizations. • Should have good knowledge of SQL, PL/SQL. • Should have experience in configuring reports in Argus Aggregate and Periodic reports. • Should have experience in Regulatory Standards like 21 CFR Part 11, ICH, GxP. • Should have experience in Argus Business and system configuration. • Should be able to provide technical architecture and design as per the user requirements. • Should have experience in performing System Integration and User Acceptance testing as part of upgrade/ implementation projects. • Should have good understanding of regulations (EU, FDA, MFDS, NMPS, Mexico, Taiwan and Russia). Show more Show less
About Client: Our client brings together Pharmacovigilance expertise, third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across Medical Affairs, Regulatory and Safety functions. Our client solutions free up responsible personnel within Pharma companies to execute their stated responsibilities while staying true to the laws of the land, and ultimately achieving a balance between compliance and managing business risks. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable them to serve large and small organizations, both in developed and emerging markets. Our client is committed to bringing focus to things that really matter for advancing patient outcomes. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable us to serve large and small organizations, both in developed and emerging markets. Position Overview: Position: Argus Configuration Specialist Location: Remote (Tokyo, Japan) Experience: 15+ years • Should have good understanding of the Pharmacovigilance/ Health Care domain. • Should have excellent knowledge of Oracle Argus Safety or other PV/Safety systems. • Should have experience in installing/configuration/validation of Argus Safety and customizations. • Should have good knowledge of SQL, PL/SQL. • Should have experience in configuring reports in Argus Aggregate and Periodic reports. • Should have experience in Regulatory Standards like 21 CFR Part 11, ICH, GxP. • Should have experience in Argus Business and system configuration. • Should be able to provide technical architecture and design as per the user requirements. • Should have experience in performing System Integration and User Acceptance testing as part of upgrade/ implementation projects. • Should have good understanding of regulations (EU, FDA, MFDS, NMPS, Mexico, Taiwan and Russia). Show more Show less
Position/Job Role: Regulatory Submission Specialist Location: Chandigarh Job Type: Full Time (On-site) Job Overview We are seeking a highly skilled and detail-oriented Submission Expert specializing in Individual Case Safety Reports (ICSR) and aggregate report submissions to join our Pharmacovigilance team. This role is critical in ensuring the timely and accurate submission of ICSRs and aggregate reports to regulatory authorities in compliance with global pharmacovigilance regulations and guidelines. Functional Responsibilities: • Manage timely submission of global ICSRs to health authorities, license partners, and CROs. • Prepare local paper submissions to the US FDA, following client-specific processes. • Proficient in ICSR submissions including MedWatch, CIOMS I, E2B(R2), and E2B(R3) for approved and investigational drugs, biologics, and medical devices. • Support safety reporting for aggregate reports/periodic safety reports and related activities. • Perform and oversee aggregate report submissions to regulatory authorities (RAs), ethics committees (ECs), institutional review boards (IRBs), and investigators. • Track and archive aggregate report submissions and correspondence. • Support EudraVigilance registration and account maintenance, as well as registration to other regulatory portals for submissions. • Generate, review, and transmit reports to global health authorities (e.g., FDA, EMA, MHRA, Health Canada). • Stays updated on regulatory requirements through regulatory intelligence to ensure compliance with submission rules across global health authorities • Maintaining the submission requirements tracker with country-level safety reporting requirements. • Ensure timely report submissions to global partners in line with PVAs. • Participate in gateway-to-gateway ICSR submission testing with health authorities and partners. • Prepare ICSR submission packages per regulatory requirements. • Monitor global submission mailboxes to address high-priority queries from authorities and partners. • Manage daily submission worklists to meet deadlines across all destinations. • Monitor the safety database for failed transmissions and resolve them promptly. • Coordinate with case processors and medical reviewers for timely case corrections. • Investigate late submissions, identify root causes, and implement corrective and preventive actions. • Provide training and mentorship to new submission team members. • Maintain accurate and up-to-date reporting rules in the safety database. • Stay informed on global PV regulations and ensure compliance in all submission activities. • Review PV Agreements and Safety Management Plans for updates impacting reporting configuration. Other Details: • Maintain comprehensive documentation of submission activities for audit and inspection readiness. Education: University degree in Life Sciences; Master’s degree preferred. Skills and personal attributes: • Fluency in spoken and written English; Good Communication skills. • Ability to work in a team with ability to prioritize the assigned work. • Proficiency in MS Office suite (Word/Excel/ PowerPoint). Minimum Work Experience: Must have a minimum of 3- 4 years of submission experience and strong knowledge of regulatory guidelines/requirements
Position: Senior Safety Database Specialist (Argus/ArisG) Location : Chandigarh Job Type: Full Time (On-Site) Our Client is a contract research organization offering Pharmacovigilance, Regulatory, Evidence Evaluation and Technology Solutions, which are phase dependent. These verticals cover planning, launch and lifecycle management of Pharmaceutical, Consumer products and Medical devices. We are based out of Chandigarh and are currently hiring for our Regulatory affairs team. Basic Function: We are seeking an experienced Safety Database Specialist like Argus, ArisG and SafetyEasy to manage critical pharmacovigilance data workflows and ensure regulatory compliance. You will work on advanced Safety Database platform configurations, manage case processing accuracy, and support global PV operations across different pharmaceutical clients. Functional Responsibilities • Configure, maintain and manage the Safety Database with high data quality and accuracy. • Administer user roles, permissions, and access controls in compliance with data privacy and regulatory requirements. • Coordinate and implement system upgrades, patches, and hotfixes in collaboration with IT and vendor teams. • Manage integration of safety databases with other systems such as E2B (R2/R3) gateways, signal detection tools, or document management systems. • Support periodic system validation, including authoring/review of validation documents (URS, FRS, IQ/OQ/PQ). • Ensure compliance with global regulatory requirements (e.g., EMA, FDA, PMDA) and standards such as 21 CFR Part 11 and EU Annex 11. • Provide end-user training and system support to case processors, medical reviewers, and QA personnel. • Participate in safety database migrations and data reconciliation projects during system transitions or audits. Job Description • Maintain documentation and audit trails, and support internal/external audits and regulatory inspections. • Generate metrics and compliance dashboards related to case processing timelines, system performance, and data quality indicators. • Liaise with database vendors (e.g., Argus) for issue resolution, enhancements, and service requests. • Draft and maintain SOPs, work instructions, and user manuals related to the safety database operations. • Troubleshoot system issues and participate in validation activities. • Collaborate with cross-functional teams and stay up-to-date on regulations. Qualifications and Experience: • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field. • 7–10 Years in Pharmacovigilance with expertise in Safety Databases • Hands-on experience with Oracle Argus Safety (latest versions) and/or other PV databases such as ArisG, SafetyEasy, VigiFlow, LSMV. • Experience with case processing workflows, E2B (R2/R3) compliance, and electronic submissions. • Proficiency in MedDRA and WHO Drug Dictionary coding standards. • Familiarity with SQL, XML, and data query tools for ad-hoc data retrieval and troubleshooting. • Exposure to safety database upgrades, patch installations, and configuration management. • Experience in system integration with document management systems, signal detection tools, or reporting platforms (e.g., Power BI, Spotfire). • Strong understanding of global PV regulations and guidelines (ICH E2B, E2D, GVP Modules, 21 CFR Part 11, EU Annex 11). • Experience in preparing for and supporting audits and inspections . • Knowledge of GxP practices, validation principles (CSV), and system lifecycle documentation (URS, FRS, IQ/OQ/PQ). • Ability to identify and resolve database/system issues with root cause analysis. • Good verbal and written communication skills to interact with cross-functional teams (PV, QA, IT, Vendors). • Strong documentation and SOP adherence skills
Argus Configuration Specialist – Japanese Location : Noida, India Experience : Minimum 12+ Years Language Requirement : Business Proficiency in Japanese (JLPT N2 or Jetro or above preferred) Availability : Immediate Joiners Preferred Relocation : Candidates with the right experience and Japanese language proficiency willing to relocate to Japan will also be considered. About our client: Our client brings together Pharmacovigilance expertise, third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across Medical Affairs, Regulatory and Safety functions. Our client solutions free up responsible personnel within Pharma companies to execute their stated responsibilities while staying true to the laws of the land and ultimately achieving a balance between compliance and managing business risks. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable them to serve large and small organizations, both in developed and emerging markets. Our client is committed to bringing focus to things that really matter for advancing patient outcomes. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable us to serve large and small organizations, both in developed and emerging markets. Role Overview: We are looking for an experienced Argus Configuration Specialist with strong Pharmacovigilance system knowledge and Japanese language proficiency, ready to take on a leadership role in system architecture and configuration for our pharma clients in Japan. Key Responsibilities: Lead configuration, installation, validation, and customization of Oracle Argus Safety systems. Translate user and business requirements into technical specifications and configuration designs. Perform Business and System Configuration of Argus modules for both standard and custom workflows. Design, configure, and validate Aggregate Reports and Periodic Safety Update Reports (PSURs). Perform and support System Integration Testing (SIT) and User Acceptance Testing (UAT). Ensure compliance with international regulations and standards including 21 CFR Part 11, ICH, GxP. Liaise with Japanese stakeholders, bridging communication gaps with fluent written and verbal skills. Support global PV implementation or upgrade projects with emphasis on Japan-specific regulatory norms. Provide ongoing maintenance, upgrades, and technical documentation. Required Skills: 12+ years of strong experience in Argus Safety configuration and PV systems implementation. Proficiency in SQL / PL-SQL for data extraction and system customization. Strong knowledge of global PV regulations (FDA, EMA, MFDS, PMDA, etc.). Business-level proficiency in Japanese (JLPT N2+ highly preferred). Ability to join immediately or within a short notice period. Willingness to work onsite in Japan. Nice to Have: Experience with Japan-specific case processing or local regulatory submission formats. Prior work in cross-cultural project teams in APAC or global safety environments. Why You Should Apply: Global Exposure: Join a project with international impact and strategic importance. Language & Leadership Edge: Use your bilingual expertise to bridge technology and compliance. Impactful Work: Play a direct role in patient safety and regulatory excellence. Relocation Support: Exceptional candidates outside Japan with required skills and language proficiency are welcome to apply. How to Apply: If you have the Argus expertise, speak fluent Japanese, and are ready for your next big move—we want to hear from you! Please submit your resume and cover letter outlining your relevant experience and achievements in Argus Configuration Management within the pharmacovigilance sector. We look forward to reviewing your application and potentially welcoming you to our dynamic team dedicated to ensuring pharmaceutical safety and compliance. Equal Opportunity Employer Our client is an equal opportunity employer committed to fostering an inclusive and diverse workplace. We offer competitive compensation packages, comprehensive benefits, and opportunities for professional growth and development.
As a Senior Safety Database Specialist at our client's contract research organization in Chandigarh, India, you will be responsible for managing critical pharmacovigilance data workflows using platforms such as Argus, ArisG, and SafetyEasy to ensure regulatory compliance. Your role will involve configuring and maintaining the Safety Database with a focus on data quality and accuracy, administering user roles in compliance with regulatory requirements, and supporting global pharmacovigilance operations for various pharmaceutical clients. Your key responsibilities will include coordinating system upgrades, managing database integrations, supporting system validation activities, ensuring compliance with global regulatory standards, providing end-user training and support, and participating in data reconciliation projects during system transitions or audits. Additionally, you will be involved in maintaining documentation, generating compliance metrics, liaising with database vendors, drafting SOPs and user manuals, troubleshooting system issues, and collaborating with cross-functional teams to stay updated on regulations. To be successful in this role, you should have a Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, or a related field with at least 7-10 years of experience in Pharmacovigilance and expertise in Safety Databases. You should have hands-on experience with Oracle Argus Safety and/or other PV databases, familiarity with coding standards, proficiency in data query tools, exposure to system integration, and a strong understanding of global PV regulations and guidelines. Excellent communication skills, documentation abilities, and adherence to SOPs are also essential for this position.,
As an Argus Configuration Specialist with over 12 years of experience and proficiency in Japanese language, you will play a crucial role in system architecture and configuration for pharmaceutical clients in Japan. Your responsibilities will include leading configuration, installation, validation, and customization of Oracle Argus Safety systems, translating user and business requirements into technical specifications, and performing business and system configuration of Argus modules. You will also design, configure, and validate Aggregate Reports and Periodic Safety Update Reports, ensure compliance with international regulations and standards, and support global PV implementation or upgrade projects with a focus on Japan-specific regulatory norms. Your strong experience in Argus Safety configuration and PV systems implementation, proficiency in SQL / PL-SQL for data extraction and system customization, and knowledge of global PV regulations will be essential for this role. Additionally, your business-level proficiency in Japanese (JLPT N2+ highly preferred) and ability to work onsite in Japan will be key requirements. You should also be able to join immediately or within a short notice period. It would be beneficial if you have experience with Japan-specific case processing or local regulatory submission formats and have worked in cross-cultural project teams in APAC or global safety environments. By joining this project, you will gain global exposure, utilize your bilingual expertise to bridge technology and compliance, and play a direct role in patient safety and regulatory excellence. If you are ready to take on this challenging and impactful role, submit your resume and cover letter showcasing your experience and achievements in Argus Configuration Management within the pharmacovigilance sector. We are looking forward to reviewing your application and potentially welcoming you to our dynamic team dedicated to ensuring pharmaceutical safety and compliance. Our client is an equal opportunity employer committed to creating an inclusive and diverse workplace. Competitive compensation packages, comprehensive benefits, and opportunities for professional growth and development are offered to all employees. Apply now and be part of a team that values diversity and fosters a culture of inclusion.,
The Senior Safety Database Specialist will be responsible for managing critical pharmacovigilance data workflows and ensuring regulatory compliance. The role involves working on advanced Safety Database platforms like Argus, ArisG, and SafetyEasy to configure and maintain the database with high data quality and accuracy. You will administer user roles, permissions, and access controls in compliance with data privacy and regulatory requirements. Additionally, the position requires coordinating and implementing system upgrades, patches, and hotfixes in collaboration with IT and vendor teams. Managing integration of safety databases with other systems, supporting periodic system validation, and ensuring compliance with global regulatory requirements are key aspects of the role. Providing end-user training and system support, participating in safety database migrations and data reconciliation projects, and maintaining documentation and audit trails are also essential responsibilities. The successful candidate will generate metrics and compliance dashboards related to case processing timelines, system performance, and data quality indicators. This individual will liaise with database vendors for issue resolution, enhancements, and service requests, as well as draft and maintain SOPs, work instructions, and user manuals related to safety database operations. Troubleshooting system issues, participating in validation activities, collaborating with cross-functional teams, and staying up-to-date on regulations are also important functions of the role. Qualifications and Experience: - Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, or a related field - 7-10 years of experience in Pharmacovigilance with expertise in Safety Databases - Hands-on experience with Oracle Argus Safety and/or other PV databases such as ArisG, SafetyEasy, VigiFlow, LSMV - Proficiency in MedDRA and WHO Drug Dictionary coding standards - Experience with case processing workflows, E2B compliance, and electronic submissions - Familiarity with SQL, XML, and data query tools for ad-hoc data retrieval and troubleshooting - Exposure to safety database upgrades, patch installations, and configuration management - Strong understanding of global PV regulations and guidelines - Experience in preparing for and supporting audits and inspections - Knowledge of GxP practices, validation principles, and system lifecycle documentation - Strong verbal and written communication skills for interaction with cross-functional teams - Strong documentation and SOP adherence skills The Senior Safety Database Specialist will play a crucial role in ensuring the integrity and compliance of pharmacovigilance data management processes within the organization.,
As a Senior Data Specialist - Reporting in Pharmacovigilance (PV) at our client's leading provider of Pharmacovigilance (PV) Technology Solutions in Noida, India, your primary responsibility will be to design, develop, and deploy multi-dimensional reports using BI Tools, preferably Cognos or OBIEE Business Intelligence solution. With a minimum of 6 years of experience in the PV domain, you will leverage your expertise in Oracle PL/SQL to write efficient SQL queries and create excel-based and RTF template-based OBIEE Reports. Your role will entail a good understanding of database concepts and the ability to work with any ETL tool, while also demonstrating proficiency in DW concepts and analytical skills. Performance tuning to ensure reports function within acceptable parameters will be a key aspect of your responsibilities. Collaborating with business users, you will design and develop Custom Reports using BI Tools, ensuring compliance with industry best practices. Your tasks will include preparing designs and code for various Custom Reporting objects, understanding business requirements, relational databases, and data models, as well as authoring installation specifications and executing unit testing. Additionally, you will be accountable for authoring project documentation/deliverables and contributing to client demo sessions/workshops. Our client values inclusivity and diversity in the workplace and offers competitive compensation packages, comprehensive benefits, and opportunities for professional growth and development. If you have a B. Tech/B.E./MCA education background and a strong track record in the PV domain, we encourage you to submit your resume and cover letter highlighting your relevant experience and achievements in AI/ML Technologies. We are excited to review your application and potentially welcome you to our client's dynamic team.,
Strategic Growth Partner – Talent Solutions - Global Markets You are invited to create the Magic — with us by your side. You’ve built relationships for years. You know the decision-makers. You’ve sat at the table when strategic hiring, scaling, or outsourcing conversations happened. Now imagine transforming those connections into thriving, long-lasting teams and an independent venture — not as an employee, but as a Strategic Growth Partner driving value, growth, and revenue under a respected global brand. At YD Talent Solutions , we help companies worldwide scale smarter and faster by delivering elite global talent across four integrated services verticals: Permanent Search – hiring the right full-time professionals to drive innovation and performance Executive Search – placing transformational C-level and leadership talent for lasting impact Offshore Technology & Support Teams – building scalable tech and business operations from India Talent Acquisition as a Service (TaaS) – an agile, subscription-based recruitment engine for growing companies We’ve also expanded into supporting virtual office setups , accounting services , and virtual assistant teams , helping businesses tap into reliable back-office support from a remote-first model. Clients trust us because we’re fast, reliable, and precise. We don’t just deliver talent — we deliver long-term solutions that unlock growth. We’re expanding globally and on-boarding a curated network of experienced professionals to represent our services in local markets. As our Strategic Growth Partner, you won’t be reporting to us — you’ll be building with us. You own the relationships. You own the results. You share in the success! Who is this for? 10+ years in building relationships in Offshore Recruitment & Staffing, IT Consulting, or Technology Solutions Deep network in technology, startups, SME, or enterprise verticals like Technology, Communications, Aerospace & Aviation, Defense, Telecom, Healthcare, Life Sciences, Pharmaceutical, Capital Markets, Wealth Management, Pharmacovigilance Strong communication, consultative selling, and relationship-building skills Experience with Onshore, Nearshore or Offshore Talent Solutions - permanent, executive, or contract hiring is a plus Entrepreneurial mindset, self-motivated, and performance-driven Whether you’re a former agency leader, staffing consultant, or enterprise client partner — if you’ve got the connections and the consultative edge, we’ll give you the platform to succeed! Let's connect & discuss.
You will be joining a client who specializes in combining Pharmacovigilance expertise, third party system knowledge, and deep technology to develop tailored solutions that address challenges within Medical Affairs, Regulatory, and Safety functions. The client's solutions are designed to allow pharmaceutical companies" personnel to fulfill their responsibilities while adhering to legal requirements, thus striking a balance between compliance and managing business risks. The solutions are agile, flexible, and scalable, leveraging advanced technologies to cater to organizations of various sizes in both developed and emerging markets. As an Argus Configuration Specialist, your primary responsibilities will include having a strong understanding of the Pharmacovigilance/Health Care domain. You should possess excellent knowledge of Oracle Argus Safety or other PV/Safety systems, with experience in installing, configuring, and validating Argus Safety as well as performing customizations. Proficiency in SQL, PL/SQL is essential, along with expertise in configuring reports in Argus Aggregate and Periodic reports. Familiarity with Regulatory Standards such as 21 CFR Part 11, ICH, and GxP is also required. Additionally, you will be responsible for Argus Business and system configuration, providing technical architecture and design based on user requirements, and conducting System Integration and User Acceptance testing as part of upgrade/implementation projects. A solid understanding of regulations from various authorities (EU, FDA, MFDS, NMPS, Mexico, Taiwan, and Russia) will be beneficial in this role. If you have 3-8 years of experience and are looking for an onsite position in Noida, India, where you can utilize your expertise in Argus configuration and contribute to the advancement of patient outcomes, we invite you to consider this exciting opportunity.,
Job Role: QMS Manager (Pharmacovigilance (PV)/GCP Auditing) Job Location: Chandigarh, India Job Type: Work from Office Job Description: Performing QA activities(listed below) independently and/or in liaison with the Quality Head: • Management of quality issues/events/deviations and CAPAs • Performing RCAs and/or providing guidance to the staff in performing RCAs • Developing CAPA plans and/or providing guidance to the staff in developing and implementing CAPAs • Planning audits using a risk-based assessment and maintaining the audit planner in accordance with applicable GVP and GCP requirements • Preparing audit schedules and performing internal audits and audits of vendors • Maintaining/managing controlled documents such as SOPs, templates etc. • Liaising with Project Leads/Functional Heads for ensuring implementation of applicable KPIs/metrics • Reviewing the quality and compliance data of various projects; performing trend analyses and interpretation of analyses • Computer system validation activities Note : This is only an indicative list, not an exhaustive list of responsibilities. Additional activities may need to be performed. Qualifications and skills: • Degree in any of the Life Sciences disciplines (Pharmacy, Microbiology, Biochemistry, Biotechnology etc.) • Experience of 5-6 years in PV and/or GCP and Quality Assurance • High level of proficiency in English, particularly written English • Auditing certification (e.g. ISO lead auditor/assessor certification) • Auditing experience, specially planning for audits using risk-based approach • Experience in performing RCAs and development of CAPAs • Working knowledge of drug safety/GCP/regulatory requirements • Strong written and verbal communication skills • Detail oriented • Passion for delivering high quality work • Ability to manage multiple and varied tasks effectively • High level of flexibility and ability to prioritize work • Ability to perform under stringent timelines • Ability to work independently or as a team member • Excellent problem-solving skills and decision-making skills • Ability to understand, interpret, analyse and present data • Computer proficiency: proficiency in the use of MS Office suite (Word/Excel/ Power Point) • Ability and willingness to travel, as needed