3 External Auditing Jobs

Purpose of the position To conduct on-site assessments against the requirements of relevant standards or specifications To provide expertise, produce surveillance and initial assessment reports and make recommendations for certification decisions. To promote the BSI product offering and solutions to our clients with the view of improving their business performance, managing risk and Making excellence a habit Key responsibilities & accountabilities Undertake management system assessments in accordance with BSI requirements. Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate. Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame. Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio. Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met. Plan/schedule workloads to make best use of own time and maximise revenue-earning activity. Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested. Maintain and develop assessment skills and technical and management system standards knowledge. Provide technical support to clients through business development, sales and customer service staff Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and Make Excellence a Habit. Candidate specifications Bachelor degree or above in Engeneering . Must be a Lead Auditor certified in 27001 Added advantage to have experince and certified for BCMS, SOC, PCI-DSS Minimum 4 years working experience in IT, with 2 years work experience in IT. Commercial understanding of compliance industry, minimum 2 years quality system management Knowledge of business processes and application of quality management standards Good verbal and written communication skills and an eye for detail Be self-motivated, flexible, and have excellent time management/planning skills Can work under pressure Willing to travel on business intensively An enthusiastic and committed team player Good public speaking and business development skill will be considered advantageous

Quality Manager (ISO 9001, ISO 13485, EU MDR, FDA, Information Security-ISO 27001, GDPR) Role: Quality Professional Desired/Preferred Qualifications: BE / B. Tech/MCA Experience : 7-12 years of experience in SW Quality Assurance. Job Description: Ensuring compliance (of products & services) with legal and normative requirements for organization (including tailoring of processes as appropriate) Quality Management System. Demonstrate ability to advanced technologies, processes, and practices in quality management. Serve as the leading point of authority and/or source of process knowledge for area of expertise. Support the Project Manager and Application Manager in activities related to the development and/or implementation of the software-specific quality activities in projects or changes (including project related Quality Reporting). Support the Quality team in implementation and compliance to ISO9001, ISO 13485 and 21 CFR Part 11 implementation for the assigned projects, applications and changes as defined in ITSM (IT process framework). Coach the project and application team members in Quality Management System and Processes application to ensure high customer satisfaction. Active participation in the complete lifecycle process of our Healthcare devices - starting with product pilot to end of Support including improving of product and process quality and effective solution for potential quality problems (e.g., Identify the project Risks, participation in project steering groups, Change Control Boards, document reviews, etc) Perform Release Reviews & Milestone Reviews as per project milestones. Monitoring and control of corrective actions in the R&D projects. Consulting & training of team members in implementing and realizing the defined processes. Conducting/participating in Process Audits, Internal Audits and External Audits, Supplier audits. Coordination and ensuring closure of audit findings within the projects. Provide input and drive continuous quality improvement initiatives in the organization. Collaborate well with the counterpart for BA/BL Quality and share the knowledge across the network, where applicable. Collaborate with all stakeholders to implement lean /agile initiatives across organization. Guide teams with Agile/Lean principles and practices (E.g. Reduce waste, VSM) to deliver value frequently and regularly to the customers. Knowledge and Experience: Expertise in Quality Management System standards and regulations (e.g. ISO 9001, ISO 13485, EU MDR, FDA, Information Security-ISO 27001, GDPR etc.) Understanding of foundational PM principles including management of scope, schedule, budget, risk, resources, quality, communications, suppliers, stakeholders, and team operations. Possess Internal Auditor/Lead Auditor Certifications from notified bodies. Experience in facing external audits and conducting internal audits. Experience in implementing Agile/Lean Principles and Practices within projects. Excellent in critical thinking, interpersonal skills, and ability to work independently on problems. Strong written and oral communication skills Good moderation and presentation skills and ability to interact with various levels of management.

Areas Of Responsibility: Shall configure, test and implement Caliber LIMS workflows and modules. Shall lead testing and implementation activities of LIMS. Coordination with CFTs for requirement gathering, requirement finalization. Shall coordinate with vendor for tracking development, testing, bug fixing and build finalization activity. Shall have knowledge of instrument integration to fetch details from CDS/Non CDS instruments. Shall be aware about administration module of LIMS Caliber. Shall have knowledge of SQL/Oracle DB to execute queries to generate customized data as well for troubleshooting purpose. To ensure that processes / workflows / modules are designed, prepared and executed as per the compliance requirements. Shall have through knowledge of validation approach for GxP applications as per regulatory guidelines and shall be able to lead validation activity for rollout of LIMS in GMP environment. To support for the timely execution and completion of qualification activities to Site users. To prepare, review/approve qualification scripts, and ensure test scripts execution activities as per approved script. To prepare, review and approve documents (Administration procedure, Validation documents, DRP etc.) related to project. To ensure support to business during hypercare and post hypercare of Go-Live of the application and resolve issues, if any. To monitor effectiveness check at the implemented sites. Identification of enhancements for process simplification, if any To ensure technical training / support for each site, whenever required. To escalate and discuss roadblocks / updates with stakeholders. To coordinate operational change management / test activities to ensure ongoing compliance with business and regulatory requirements. To update the issue tracker for the projects handled and support for closure of the issues. To handle the Quality management system and anticipating the investigation, initiate/ review, Impact assessment of change control, incidents, Deviations and CAPA. To ensure successful handover of the projects to their respective business owners, upon completion. Support sites during the regulatory audits and internal/ external audit observations. To have good hands on MS office (i.e. Word / Excel / Power Point) and other computer skills. Job Requirements: Educational Qualification : B.E./B.Tech., BCA/MCA Specific Certification : NA Skills : Experience of LIMS Caliber Global Rollout/ Configuration. Experience : 10-12 ( Caliber LIMS) Selection Process: Interested Candidates are mandatorily required to apply through the listing on Jigya. Only applications received through Jigya will be evaluated further. Shortlisted candidates may need to appear in an Online Assessment and/or a Technical Screening interview administered by Jigya, on behalf on Sun Pharma Candidates selected after the screening rounds will be processed further by Sun Pharma