2 Client Audits Jobs

The Quality Lead position at ProPharma involves driving positive change and process improvement in the assigned region. This role serves as an independent and objective entity, supporting various operational teams and performing quality activities as per ProPharma Group's Quality Policy and procedures. The Quality Lead is responsible for Audit Management, Deviation and CAPA Management, Document Control, and other Quality Management System activities. Developing, managing, and executing quality management processes to ensure compliance with regulatory requirements is a key aspect of this role. Essential Functions: - Maintaining awareness of and ensuring adherence to applicable SOPs/controlled documents, regulations, guidelines, and client agreements. - Serving as a control point for SOPs/controlled documents and Quality Management System documents. - Contributing to the creation of controlled documents such as SOPs and Work Instructions. - Supporting the internal quality program including quality assurance and quality control. - Assisting in investigating service complaints and deviations, identifying root cause and CAPAs, and communicating these to the Managers. - Collaborating with Operational and Client Services Managers to support preparation for client audits and regulatory inspections. - Hosting client audits and regulatory inspections at ProPharma Group and acting as an SME for quality topics. - Developing responses to CAPAs arising from client audits and regulatory inspections, with support from Operations Managers, Client Services, and Global Quality, and tracking to completion and closure. - Participating in relevant client operational meetings as directed by Management. - Supporting the Quality Manager in the Regional Quality Committee and acting as a regional representative in the Global Quality Committee. - Proactively identifying improvement opportunities to support the development of ProPharma Group as a leading provider of outsourced global Medical Information solutions. - Identifying any issues that could potentially impact services and escalating areas of concern within the business to Management, with potential corrective actions. - Other responsibilities as assigned. Necessary Skills & Abilities: - Excellent attention to detail and focus on quality. - Strong verbal and written communication skills. - Excellent workload management skills. - Ability to prioritize workload and meet deadlines. - Excellent questioning and listening skills. - Capable of resolving conflict constructively. - Able to collaborate with colleagues in other departments effectively. - Ability to speak effectively in interpersonal situations and presentations. - Possesses a service-oriented approach. - Flexible and proactive toward changing needs. - Good understanding of quality assurance regulations and guidelines, preferably related to cGxP. - Quality Assurance experience in internal and external audits, maintaining regulated documents, and training files, preferably related to cGxP. - Knowledge of FDA regulations for adverse event and product complaint reporting. - Proficiency in MS Word, Excel, and PowerPoint. Educational Requirements: - University/Bachelor's degree and/or appropriate relevant work experience. Experience Required: - 5 years Quality experience in pharmaceutical or medical device industries or other regulated industry. - Previous experience in data mining, analysis, and presentation. - Previous audit experience preferred. ProPharma Group is committed to diversity, equity, and inclusion, creating a workplace where employees can be their authentic selves and are encouraged to be innovative and collaborative. As an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. Please note that ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Phone calls or emails regarding this posting are not accepted.,

Job Title: Informatics Qualification Postgraduate in Science/MCA with a minimum of 10- 18 years of IT experience in the Pharmaceutical / Life science domain Technical Skills Experience in demonstrating a track record of delivering scientific solutions in the pharmaceutical and CRO industry. Experience in the implementation of Informatic applications like (Electronic Laboratory Notebooks(elNB), Laboratory Information Management System, Chromatography Data system (CDS) and other scientific applications. Experience with Software development life cycle (SDLC) and Computer System Validation (CSV). Should have experience in running projects with CSV life cycle. Candidate should have knowledge of current regulatory & Guidelines (GAMP5) for CSV, i.e. 21 CFR Part 11 ERES, Part 820, Part 210 & 211, EU Annex 11, ICHQ9 and SOP requirements of computerized systems w.r.t. data security, traceability and integrity. Candidate should be familiar with GCP, GLP and GMP guidelines/SOPs. The candidate should have skills in managing Regulatory & Client Audits (experience in supporting internal and external audits). Other Skills: Strong leadership, communication, consulting and influencing skills. Must have experience in resource management - channelizing resources to track current and future program resource assignments. Must have excellent team collaboration skills and the ability to lead and motivate cross-functional teams. Strong analytical and communication skills are required. Roles and Responsibilities: Responsible for supporting informatics applications of the assigned departments. In collaboration with the scientific community identify, evaluate and implement software applications meeting business requirements. Implement new projects/solutions as per business needs. Coordinates between scientists and vendors for any solution development/implementation Ensure effective utilization of scientific systems and applications Coordinate with Syngene clients and/or vendors to roll out scientific applications extended to Syngene Facilitate computer system validation and ensures that scientific applications are GxP compliant as per the operating unit requirements Responsible for ensuring 21 CFR Part 11 compliance for enterprise & standalone applications Focus on near-zero downtime for enterprise applications Technical support and administration of scientific and associated applications. Challenges / error handling, escalation and troubleshooting of scientific and associated applications. Responsible for effective coordination among clients, operating unit and internal IT team for the application / infrastructure challenges faced by the operating unit to minimize or eradicate the downtime Responsible to provide the right solution for the challenges faced by the operating units Responsible for implementation / suggestion of any IT related process improvements for the operating units Location: Bangalore