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3.0 - 5.0 years
5 - 8 Lacs
Bengaluru
Work from Office
Key expectations from the role: To maintain a comprehensive database of all statutory compliances and licenses for Aster DM healthcare operations in India To ensure that all compliance requirements for units are updated in the AVACOM (system) and track them for completion on a timely basis Research and stay updated of specific licensing and statutory compliance requirements for various legal specializations within the organization. Develop, implement, and manage a robust compliance program that encompasses all our hospitals and departments in India, aligned with relevant Indian regulations and best practices. Regular follow up with stakeholders on the compliance closure (adherence) to ensure that these are done on a timely basis. Conduct regular compliance risk assessments to identify and mitigate potential areas of non-compliance, including but not limited to: o Medical Council of India (MCI) regulations, National Pharmaceutical Pricing Authority (NPPA) regulations o Clinical Establishment (Registration and Regulation) Act, 2010 (CE Act), Bio-Medical Waste Management Rules, 2016 o Data Protection in Healthcare (consideration of upcoming regulations), o Other relevant Indian laws and regulations (e.g. HR, CS, GST, IT etc.) Develop and deliver effective compliance training programs for all employees, including physicians, nurses, administrative staff, and allied healthcare professionals, ensuring clear understanding of Indian healthcare regulations and ethical conduct. Investigate and resolve any potential compliance issues or concerns raised by internal or external stakeholders, and ensure appropriate corrective action is taken. Any non-compliances identified as part of any of the audit, shall be followed up for timely remediation. Provide ongoing guidance and support to hospital leadership and staff on all compliance matters in India. Qualification and Experience Masters in healthcare administration, Business Administration, or any other Professional course or a related field (masters degree preferred). A bachelors degree in law would be an added advantage. Desirable Experience - Minimum of 3- 5 years of related exposure in the Indian healthcare industry. In-depth knowledge of Indian laws (specific focus on health care related requirements), including those mentioned in the responsibilities section. Proven experience in developing, implementing, and managing a comprehensive compliance program in an Indian healthcare setting. Excellent communication, interpersonal, and leadership skills with the ability to influence and guide diverse stakeholders. Strong analytical and problem-solving abilities with a focus on finding practical solutions within the Indian regulatory landscape. Ability to work independently, manage multiple priorities effectively, and meet deadlines. Excellent attention to detail and a commitment to accuracy in all compliance-related matters. Fluency in English (both written and spoken) with understanding of Malayalam is a must for this role.
Posted 2 weeks ago
3.0 - 5.0 years
3 - 5 Lacs
Navi Mumbai
Work from Office
Develop and manage comprehensive pharmaceutical-grade documentation throughout the project lifecycle.Prepare key qualification documents: Design Qualification (DQ), Functional Design Specification (FDS), Hardware Design Specification (HDS). Required Candidate profile • 3-5 years of experience specifically in pharmaceutical documentation or a similar quality/validation role within a regulated industry. • Strong understanding and practical experience with DQ,FDS,HDS
Posted 2 weeks ago
5.0 - 8.0 years
6 - 10 Lacs
Bengaluru
Work from Office
Candidate must currently be in Bangalore Must be fluent in Spoken Kannada Conduct routine patrols Monitor surveillance Enforce process and policies Documentation Respond to Emergencies Key Responsibilities: Supervise security guards and third-party vendors. Monitor CCTV and security systems. Conduct regular security audits and risk assessments. Handle visitor management, access control, and emergency response drills. Investigate security breaches or suspicious activities. Requirements: Background in defense/security preferred. Knowledge of fire safety protocols, emergency handling, and local law enforcement coordination. Strong leadership, communication, and observation skills.
Posted 2 weeks ago
4.0 - 7.0 years
2 - 11 Lacs
Bengaluru / Bangalore, Karnataka, India
On-site
Responsible for engineering and proper functioning of the Global Security tooling estate. Security Orchestration and Automation for the Infosys Quartz Security Operations team and Global security tooling landscape to empower Security operational teams to improve their response process. Responsible for on boarding of data sources into the SIEM, ensuring the Threat and vulnerability tooling landscape work correctly and security monitor the right assets and other security tools used in Infosys Quartzl run smoothly and empower the Security Operational teams to have relevant data to understand what is going on in cyber security landscape and are able to make the right priority calls. Continuously improve Integration and automation of the Global Security tooling estate Close collaboration with the Infosys Quartz Security operations and other Operational teams, Architecture and Engineering teams and other Business units to align activities, drive improvements and has the right priorities set for maximum effect. Review and improve security requirements set in policies / standards and guidelines and make sure that these are following industry best practice. We tend to look for people with: Essential:Experience as a Security engineer Experience working with Security Operations, Security engineering and security analysts teams Advanced experience with Security Orchestration, Automation, and Response (SOAR) Solid understanding of DevSecOps, Networking, Security and Monitoring Awareness of security threats and defensive strategies within the critical infrastructure, including techniques, tactics, and procedures (TTPs) that threat actors utilize to attack an organization. Experience with several of the following: SIEM / Splunk (strongly preferred), Kibana / ELK Lacework Wiz Prisma Rapid7, c3m, whitehat (strongly preferred) Imperva, Database security monitoring Anomoli DevOps Azure, GCP, AWS, OSI cloud services MySQL / PostgreSQL PowerShell Strong understanding and hands-on experience in maintaining or security monitoring a number of the below: Microsoft 365, Windows Desktop and Server, Active Directory RedHat Enterprise Linux or derivatives Debian Linux or derivatives Strong understanding and ability to setup various platforms in an advance matter with: Network essentials such as IPv4, IPv6 networking Host and Network firewalls Standard host monitoring via SNMP and tools like Nagios, Cacti, Zabbix etc Experience in working with a wide range of stakeholders in the context of improving security and incident respond. Experience with monitoring and analytics solutions (e.g. Arbor threat mitigation suite, Splunk, Grafana, Elastic Stack etc.). Desirable: Bachelor or Masters Degree in computer sciences or related fields (or equivalent years of experience).
Posted 2 weeks ago
6.0 - 10.0 years
5 - 7 Lacs
Jhagadia
Work from Office
Design electrical systems, control panels, and wiring layouts to meet the needs of plant equipment, machinery, and automation systems. Develop electrical schematics, control diagrams, and specifications for new systems and upgrades to existing systems. Select and specify electrical components, motors, and control devices in compliance with industry standards. Oversee and participate in the installation of electrical equipment and systems, ensuring the installation meets the engineering specifications, safety standards, and codes. Commission electrical systems, ensuring proper setup, calibration, and functionality before they are fully integrated into the production line. Monitor the performance of electrical systems and conduct routine inspections to ensure continuous operation and identify areas requiring maintenance or repair. Work with control systems (e.g., PLC, SCADA) to optimize production processes and ensure smooth operation. Implement electrical safety procedures and perform risk assessments to ensure safe operation of equipment and systems. Work closely with mechanical, civil, and process engineers to ensure integration between electrical systems and other plant systems. Maintain accurate records of electrical designs, modifications, maintenance schedules, and performance logs.
Posted 2 weeks ago
2.0 - 6.0 years
5 - 8 Lacs
Bengaluru
Work from Office
Warm Greetings from RIVERA MANPOWER SERVICES!!!! Kindly Note: We are looking @ Minimum 2 Year of an experience into Fraud Investigation /Risk Investigation / SAR/ Transaction Monitoring in International BANKING oNLY. Call the below mentioned Number to book your slots and grab the opportunity. CHETHANA @ 7829336034 /9986267393 /9380300644 Immediate Joiners onlu Roles and Responsibilities : Investigation on Trigger alert for each customer account. Understanding Customer details, source of income activity pattern. Review on customer transaction pattern in the triggered account. Review the associate accounts where the funds being received and being transferred. Eliminate the normal transaction like grocery, shopping, restaurant and other transaction. Investigation on the remaining activity to find any suspicious or involved in fraud. Performing external open search to understand any negative news on the main suspect. Performing KYC check to validate original document being submitted. Off- boarding the client is he has been involved in terms and condition breach. Reporting to regulatory National Crime Agency if any Financial Crime being observed. Understanding customer transaction patter in the account. Fast movement of money like Top-up followed by external transfer or ATM withdrawal. Structuring of money just to avoid the threshold of the system. Desired Candidate Profile *Possess good analytical skills - detail oriented *Possess good communication skills, both oral and written *Be familiar with Microsoft applications and working knowledge of MS excel *Have a good attitude - should be committed to the workPerks and Benefits *One Ways Cab Provided .*Incentives Regards,Chethana - 7829336034 Rivera manpower services
Posted 2 weeks ago
5.0 - 6.0 years
7 - 9 Lacs
Noida
Work from Office
We are seeking a highly skilled and experienced Environmental, Health, and Safety (EHS) Specialist with 5-6 years of expertise in implementing, monitoring, and enhancing EHS programs. The ideal candidate will have solid experience in EHS audits, a strong understanding of Indian and international EHS regulations, and a background in air quality assessment. Additional knowledge in industrial hygiene (IH) and product stewardship will be an added advantage. This role requires a proactive individual with strong analytical skills, attention to detail, and an ability to lead compliance initiatives while ensuring a safe and sustainable work environment. Role Accountabilities: Plan, conduct, and document EHS audits to assess compliance with Indian and international regulations, standards, and company policies. Conduct hazard identification, risk assessments (HIRA), and job safety analyses (JSA). Stay updated on Indian and global EHS regulations and ensure compliance across all operations. Conduct compliance audit, ISO audits, air quality assessments, including monitoring and analysis of emissions. Collaborate with cross-functional teams to ensure that air quality standards are met. Conduct hazard identification, risk assessments (HIRA), and job safety analyses (JSA). Qualifications & Experience: Degree in an Engineering, Environment sciences, Environment Engineering or Sustainability ISO Certified or IMS / Internal/ Lead Auditor Certified Soft Skills: In-depth understanding of Indian and international EHS regulations (e.g., OSHA, ISO 14001, ISO 45001, CPCB, NBC, etc.). Strong knowledge of air quality assessment tools and methodologies. Knowledge on decarbonization strategies Familiarity with industrial hygiene principles and practices. Knowledge of product stewardship principles and regulatory requirements. Strong analytical, problem-solving, and organizational skills. Excellent communication and training abilities
Posted 2 weeks ago
4.0 - 5.0 years
6 - 7 Lacs
Bengaluru
Work from Office
Responsibilities: Develop, implement, and enforce health and safety policies in compliance with company standards and regulations. Conduct risk assessments, incident investigations, and audits to identify and mitigate hazards. Promote a strong safety culture through training, awareness programs, and regular inspections. Establish emergency response plans and ensure employee preparedness. Monitor and ensure compliance with local H&S regulations and industry best practices. Collaborate with management to integrate H&S into daily operations and strategic initiatives. Qualifications Qualifications: A bachelor's degree in Occupational Health & Safety, Environmental Science, Engineering, or a related field, with 4-5 years of relevant experience. Certifications such as NEBOSH, IOSH, or equivalent preferred. Strong knowledge of H&S regulations, risk management, and auditing processes. Excellent communication, problem-solving, and analytical skills.
Posted 2 weeks ago
10.0 - 15.0 years
0 - 0 Lacs
Vadodara
Work from Office
Responsibilities: * Conduct hazard analyses & risk assessments * Develop safety strategies & procedures * Ensure compliance with safety standards * Oversee safety inspections & training programs Location - Vadodara Experience - 10 -15 years
Posted 2 weeks ago
9.0 - 14.0 years
7 - 10 Lacs
Vadodara
Work from Office
Responsibilities: * Conduct hazard analyses & risk assessments * Develop safety strategies & procedures * Ensure compliance with safety standards * Oversee safety inspections & training programs Location - Vadodara Experience - 9 -15 years
Posted 2 weeks ago
8.0 - 10.0 years
0 Lacs
Bengaluru, Delhi / NCR, Mumbai (All Areas)
Work from Office
Job Purpose: To ensure compliance with ATEX workplace directives and related explosive atmosphere standards across petrochemical, chemical, and oil & gas operations. The ATEX Expert will assess, design, and guide implementation of explosion protection strategies, ensuring safe operations in hazardous areas. Key Responsibilities: Ensure compliance with ATEX Directive 2014/34/EU and Directive 1999/92/EC across all hazardous zones. Perform hazardous area classification (HAC) and zoning based on IEC/EN standards. Evaluate and select ATEX-certified electrical and non-electrical equipment for use in Zone 0, Zone 1, and Zone 2. Conduct risk assessments, ignition source identification , and explosion protection document (EPD) preparation. Support HAZOP, HAZID, and SIL studies from an ATEX and explosion safety perspective. Coordinate inspection, maintenance, and certification of ATEX equipment as per IEC 60079 series standards. Provide technical training and awareness to internal teams on ATEX principles and equipment usage. Liaise with Notified Bodies , certification agencies, and vendors regarding ATEX conformity and documentation. Support engineering teams during project design, construction, and commissioning phases to ensure ATEX compliance. Develop and maintain internal ATEX compliance audit programs and monitor corrective actions. Qualifications & Experience: Minimum 8 years of experience in petrochemical, chemical, or oil & gas industries handling ATEX responsibilities. Bachelors / Masters degree in Electrical / Mechanical / Chemical Engineering or relevant discipline. ATEX / IECEx certification (CompEx, TV, or equivalent) preferred. Strong knowledge of IEC 60079 , EN 1127 , and other related explosion protection standards. Machinery safety and consumer products Risk assessment (EN 12100) Functional safety of machines (EN 13849 series) Conducting Hazardous Area Classification study, Explosion Risk Assessment and preparing Explosion Protection Document in accordance with ATEX workplace directive Performing design reviews and on-site inspections for ATEX and Machinery
Posted 2 weeks ago
5.0 - 10.0 years
4 - 8 Lacs
Kolkata
Work from Office
Project Role : Security Advisor Project Role Description : Lead the effort and teams to enable development and implementation of proprietary and innovative security solutions. Assess, manage and ensure compliance to risk reducing behaviors and processes. Must have skills : Identity Access Management (IAM), ControlM Administration, CyberArk Privileged Access Management, Google Cloud Platform Administration, Unix, Python, Shell Scripting, Data Lake, MYSQL, Java, JavaSc Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : A Bachelors or Masters Degree in Technology or similar streams as fulltime education is required Summary :As a Security Advisor, you will lead the effort and teams to enable the development and implementation of proprietary and innovative security solutions. Your typical day will involve assessing and managing security risks, ensuring compliance with established processes, and collaborating with various teams to enhance security measures. You will play a crucial role in guiding the organization towards adopting best practices in security management, while also fostering a culture of risk awareness and proactive security measures across the organization. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Provide solutions to problems for their immediate team and across multiple teams.- Facilitate training sessions to enhance team knowledge and skills in security practices.- Monitor and evaluate the effectiveness of security solutions and recommend improvements. Professional & Technical Skills: - Must To Have Skills: Proficiency in Identity Access Management (IAM), CyberArk Privileged Access Management, Google Cloud Platform Administration, ControlM Administration.- Good To Have Skills: Experience with security compliance frameworks such as ISO 27001 or NIST.- Strong understanding of risk assessment methodologies and security best practices.- Experience in implementing security policies and procedures.- Familiarity with incident response and management processes. Additional Information:- The candidate should have minimum 7.5 years of experience in Identity Access Management (IAM).- This position is based at our Kolkata office.- A Bachelors or Masters Degree in Technology or similar streams as fulltime education is required. Qualification A Bachelors or Masters Degree in Technology or similar streams as fulltime education is required
Posted 2 weeks ago
0.0 - 12.0 years
6 - 7 Lacs
Surat
Work from Office
Tata Consulting Engineers Limited is looking for Safety Engineer to join our dynamic team and embark on a rewarding career journey We are seeking a dedicated and detail-oriented Safety Engineer to join our team As a Safety Engineer, you will be responsible for identifying and mitigating potential safety hazards in the workplace and ensuring compliance with safety regulations and standards You will work collaboratively with cross-functional teams to develop and implement safety policies, procedures, and training programs to promote a safe and healthy work environment Responsibilities:Conduct thorough risk assessments and safety audits to identify potential hazards in the workplace Develop and implement safety policies, procedures, and guidelines to ensure compliance with local, state, and federal regulations Collaborate with cross-functional teams to assess and mitigate risks associated with new processes, equipment, or facility modifications Provide safety expertise and guidance to project teams during the design and implementation of new projects or processes Develop and deliver safety training programs to educate employees on safety protocols, emergency response procedures, and best practices Investigate incidents and accidents, analyze root causes, and develop corrective action plans to prevent reoccurrence Maintain accurate safety records, including incident reports, inspection findings, and safety-related documentation Stay updated with industry trends, emerging safety technologies, and regulatory changes, ensuring compliance with the latest standards Conduct regular safety inspections and audits to ensure ongoing compliance and identify areas for improvement Collaborate with vendors and suppliers to evaluate and select safety equipment and personal protective gear Foster a culture of safety awareness by promoting proactive safety practices and encouraging employee engagement in safety initiatives
Posted 2 weeks ago
15.0 - 20.0 years
10 - 14 Lacs
Bengaluru
Work from Office
Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Physical Site Security Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that project goals are met, facilitating discussions to address challenges, and guiding your team through the development process. You will also engage in strategic planning to align application functionalities with business objectives, ensuring that the solutions provided are effective and efficient. Your role will require you to be proactive in identifying areas for improvement and implementing best practices to enhance application performance and user experience. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Provide solutions to problems for their immediate team and across multiple teams.- Facilitate training and development opportunities for team members to enhance their skills.- Monitor project progress and ensure timely delivery of milestones. Professional & Technical Skills: - Must To Have Skills: Proficiency in Physical Site Security.- Good To Have Skills: Experience with security risk assessments and mitigation strategies.- Strong understanding of physical security systems and technologies.- Experience in developing and implementing security policies and procedures.- Familiarity with compliance standards related to physical security. Additional Information:- The candidate should have minimum 5 years of experience in Physical Site Security.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education
Posted 2 weeks ago
3.0 - 5.0 years
5 - 10 Lacs
Bengaluru
Work from Office
Key Responsibilities : Conduct Quality Audits and Survey Quality Audits to ensure compliance with set standards. Perform detailed fact-finding, documenting, and reporting to management. Ensure compliance assurance by scrutinizing RM (Relationship Manager) conduct at the household level. Identify and mitigate risks in processes and operations, ensuring risk mitigation and compliance. Detect and prevent fraud in field activities. Uncover and report SOP non-compliances to enhance operational efficiency . Identify and document external infiltration or intrusion attempts. Requirements : Minimum 3 -4 years of experience in the same background. Strong knowledge of auditing processes and compliance regulations. Ability to work and travel extensively in the field and conduct thorough inspections. High attention to detail for identifying risks, inefficiencies, and fraud. Excellent communication and reporting skills to relay findings to management. Proficiency in data collection, analysis, and reporting. Qualification - Post Graduate preferred but not mandatory, Min Qualification - Any Graduate CTC - Open for the right candidate
Posted 2 weeks ago
1.0 - 4.0 years
2 - 4 Lacs
Pune
Work from Office
We are seeking Safety Officer to join us Opportunity to work in a dynamic & growing manufacturing environment. Professional development through continuous training & exposure to safety management practices. Required Candidate profile Awareness of upcoming SHE policies & changes. Excellent communication and interpersonal skills. Safety Certification+ Graduate is required Male preferred Pune candidates preferred
Posted 2 weeks ago
10.0 - 13.0 years
10 - 13 Lacs
Hyderabad / Secunderabad, Telangana, Telangana, India
On-site
As a Director Quality Assurance, Product Complaint and Surveillance you will report to the Executive Director, Quality Head and: Drive execution of the global complaints business process and continuous improvement Maintain oversight of complaints throughout the lifecycle from intake, processing, and through closure Apply in-depth knowledge and subject matter expertise to determine the steps necessary to improve the complaint management system to address the root causes for the complaints Provide accurate and robust surveillance information that meets global health authorities and Amgen requirements Manage the Business Performance team for Combination Product Quality at AIN to ensure timely completion of goals and objectives. Leverage expertise and effectively engages with technical functions to translate risk assessments into complaint codes and decision trees and ensure continual alignment with regulatory filings Manage data sources used for trending, provide necessary data to technical teams for advanced analysis Ensure alignment between linked product complaint and adverse events investigations with Safety data and support for requests from global health authorities regarding the complaints process. Communicate potential product quality or business risks to leadership Escalate critical issues and findings to ensure incorporation into Management Review Contribute to inspection readiness activities Lead cross-functional initiatives to improve and strengthen complaint management system and processes at Amgen Interpret SOPs and regulatory requirements Own Process Standards, Process Overview and SOPs and ensures alignment with document hierarchy and templates Set project timelines and priorities for key initiatives and/or team activities Provide guidance and technical advice to key stakeholders involved in managing complaints Lead and develops a team, providing staff member supervision and on-going coaching Drive Operational Excellence as it pertains to complaint management processes and system Strategically plan, analyze, and manage resources to include budget, contractors, staff, etc. Act upon performance metrics and process issues, implementing actions to drive continuous improvement and escalation to management if needed Basic Qualifications: Doctorate degree and 8 years of Quality experience OR Masters degree and 15 years of Quality experience OR Bachelors degree and 20 years of Quality experienceAND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry Advanced Degree in a Science Field Combination products (medicinal product and device) expertise Strong problem solving and data driven analytics Strong leadership skills and the ability to oversee multiple projects simultaneously Able to successfully manage workload to meet timelines Able to respond and provide astute advice quickly in difficult scenarios or in response to tough questions Strong change management skills Familiarity with basic project management tools Ability to negotiate a strategic position after taking feedback from multiple sources Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and with high-quality results Strong aptitude for coaching and providing on-going mentoring and guidance to team Ability to operate in a matrix or team environment with site, functional, and executive leadership Experience driving decision making by using DAI principles Relevant experience having led a complaints organization Experience leading and coaching a diverse, globally dispersed team Knowledge of cGMP regulations (FDA, EMEA, TUV, Health Canada) and industry standards (ISO, ICH, PICs) Strong verbal and written communication. Ability to communicate effectively with Senior and Executive Leadership Highly skilled at interacting effectively with inspectors and agency regulators Working knowledge of applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls) Ability to succinctly communicate level of risk, urgency, or impact to the business Practical knowledge of human factors principles and best practices Practical knowledge of risk assessments and their application to complaints investigation Ability to travel +/- 20% of time to domestic and international Amgen sites; ability to flex working hours to maximize interactions with global teams.
Posted 3 weeks ago
6.0 - 8.0 years
10 - 19 Lacs
Bengaluru
Hybrid
A subject matter expert in Data Protection laws and having good experience in handling Data Privacy matters. Have experience in conducting DPIA/PIA for a Global Company. Have extensive experience and knowledge of data privacy matters including GDPR. Experience in Middle East countries would be preferred but is not necessary. Have a good understanding of emerging technologies such as cloud computing, RPA, AI etc. Excellent interpersonal skills with the ability to effectively communicate with Business stakeholders.
Posted 3 weeks ago
8.0 - 13.0 years
10 - 15 Lacs
Hyderabad
Work from Office
As a Director Quality Assurance, Product Complaint and Surveillance you will report to the Executive Director, Quality Head and: Drive execution of the global complaints business process and continuous improvement Maintain oversight of complaints throughout the lifecycle from intake, processing, and through closure Apply in-depth knowledge and subject matter expertise to determine the steps necessary to improve the complaint management system to address the root causes for the complaints Provide accurate and robust surveillance information that meets global health authorities and Amgen requirements Manage the Business Performance team for Combination Product Quality at AIN to ensure timely completion of goals and objectives. Leverage expertise and effectively engages with technical functions to translate risk assessments into complaint codes and decision trees and ensure continual alignment with regulatory filings Manage data sources used for trending, provide necessary data to technical teams for advanced analysis Ensure alignment between linked product complaint and adverse events investigations with Safety data and support for requests from global health authorities regarding the complaints process. Communicate potential product quality or business risks to leadership Escalate critical issues and findings to ensure incorporation into Management Review Contribute to inspection readiness activities Lead cross-functional initiatives to improve and strengthen complaint management system and processes at Amgen Interpret SOPs and regulatory requirements Own Process Standards, Process Overview and SOPs and ensures alignment with document hierarchy and templates Set project timelines and priorities for key initiatives and/or team activities Provide guidance and technical advice to key stakeholders involved in managing complaints Lead and develops a team, providing staff member supervision and on-going coaching Drive Operational Excellence as it pertains to complaint management processes and system Strategically plan, analyze, and manage resources to include budget, contractors, staff, etc. Act upon performance metrics and process issues, implementing actions to drive continuous improvement and escalation to management if needed What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 8 years of Quality experienceOR Masters degree and 15 years of Quality experience OR Bachelors degree and 20 years of Quality experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry Advanced Degree in a Science Field Combination products (medicinal product and device) expertise Strong problem solving and data driven analytics Strong leadership skills and the ability to oversee multiple projects simultaneously Able to successfully manage workload to meet timelines Able to respond and provide astute advice quickly in difficult scenarios or in response to tough questions Strong change management skills Familiarity with basic project management tools Ability to negotiate a strategic position after taking feedback from multiple sources Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and with high-quality results Strong aptitude for coaching and providing on-going mentoring and guidance to team Ability to operate in a matrix or team environment with site, functional, and executive leadership Experience driving decision making by using DAI principles Relevant experience having led a complaints organization Experience leading and coaching a diverse, globally dispersed team Knowledge of cGMP regulations (FDA, EMEA, TUV, Health Canada) and industry standards (ISO, ICH, PICs) Strong verbal and written communication. Ability to communicate effectively with Senior and Executive Leadership Highly skilled at interacting effectively with inspectors and agency regulators Working knowledge of applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls) Ability to succinctly communicate level of risk, urgency, or impact to the business Practical knowledge of human factors principles and best practices Practical knowledge of risk assessments and their application to complaints investigation Ability to travel +/- 20% of time to domestic and international Amgen sites; ability to flex working hours to maximize interactions with global teams.
Posted 3 weeks ago
4.0 - 7.0 years
6 - 9 Lacs
Mumbai
Work from Office
Your day at NTT DATA The Security Managed Services Engineer (L2) is a developing engineering role, responsible for providing a managed service to clients to ensure that their Security Infrastructures and systems remain operational. Through the proactive monitoring, identifying, investigating, and resolving of technical incidents and problems, this role is able to restore service to clients. The primary objective of this role is to proactively review client requests or tickets and apply technical/process knowledge to resolve them without breaching service level agreement (SLA) and focuses on second-line support for incidents and requests with a medium level of complexity. The Security Managed Services Engineer (L2) may also contribute to / support on project work as and when required. What youll be doing Key Responsibilities: Integrating UEBA with other security systems. Managing and configuring UEBA tools and agents. Conducting threat modelling and risk assessments. Knowledge and Attributes: Ability to communicate and work across different cultures and social groups. Ability to plan activities and projects well in advance, and takes into account possible changing circumstances. Ability to maintain a positive outlook at work. Ability to work well in a pressurized environment. Ability to work hard and put in longer hours when it is necessary. Ability to apply active listening techniques such as paraphrasing the message to confirm understanding, probing for further relevant information, and refraining from interrupting. Ability to adapt to changing circumstances. Ability to place clients at the forefront of all interactions, understanding their requirements, and creating a positive client experience throughout the total client journey. Academic Qualifications and Certifications: Bachelors degree or equivalent qualification in IT/Computing (or demonstrated equivalent work experience). 3+ years of experience CertificationProposed OEM Level Certification is a must. Required Experience: Moderate level of relevant managed services experience handling Security Infrastructure. Moderate level of knowledge in ticketing tools preferably Service Now. Moderate level of working knowledge of ITIL processes. Moderate level of experience working with vendors and/or 3rd parties.
Posted 3 weeks ago
1.0 - 4.0 years
3 - 6 Lacs
Hyderabad
Hybrid
Your day at NTT DATA The Risk Analyst is a seasoned subject matter expert, responsible for assessing and managing risks to ensure the security, integrity, and resilience of the organization's operations and services. This role involves identifying potential threats, analyzing vulnerabilities, and providing recommendations to mitigate risks. Through proactive risk assessment and collaboration with cross-functional teams, this role contributes to the organization's efforts to maintain a secure and compliant environment. Key responsibilities: Analyzes risk to business activities and operations. Identifies areas of potential loss or damage for current and proposed business and financial operations, processes, structures and cyber-risk exposure and quantifies impact Implements and evaluates compliance with business and cyber risk-reduction policies, processes and standards. May participate in the development and maintenance of disaster recovery and business continuity plans. Supports organizational processes and programs for mitigation of financial risk, including administration of insurance. May support and administer security and health/safety programs in addition to risk management activities. Performs any other related task as required by management. To thrive in this role, you need to have: Strong understanding of risk assessment methodologies, global regulations, and compliance requirements. Proficiency in data analysis tools and techniques for identifying trends, patterns, and potential risks. Excellent analytical skills and attention to detail. Effective communication skills to convey complex risk concepts to a global audience. Cultural sensitivity and adaptability to work across different regions and time zones Strong problem-solving skills and ability to work collaboratively with cross-functional and global teams. Academic qualifications and certifications: Bachelor's degree or equivalent in Business, Information Security, Risk Management or related field. Relevant certifications such as CISM, CRISC, CISSP, CIPP preferred. Required experience: Seasoned years of experience as a Risk Analyst, preferably in a global organization with diverse operations.
Posted 3 weeks ago
4.0 - 6.0 years
2 - 6 Lacs
Mumbai
Work from Office
SBI-SG GLOBAL SECURITIES SERVICES PRIVATE LIMITED is looking for Assistant Manager - Compliance. to join our dynamic team and embark on a rewarding career journey Regulatory Compliance: Monitor and ensure compliance with all relevant laws, regulations, and industry standards that affect the organization Policy Development: Develop, implement, and maintain compliance policies, procedures, and programs to mitigate risks and maintain adherence to regulations Risk Assessment:Risk Analysis: Conduct risk assessments and analyze potential compliance risks, providing recommendations for risk mitigation Training and Education:Training Programs: Develop and deliver compliance training programs for employees to ensure awareness and understanding of compliance requirements Reporting:Reporting: Prepare and submit compliance reports to senior management and regulatory authorities as required Investigations:Incident Management: Investigate compliance-related incidents, violations, or concerns and recommend corrective actions Audits:Internal Audits: Coordinate and participate in internal compliance audits to assess the effectiveness of controls and policies Monitoring and Testing:Compliance Testing: Perform ongoing monitoring and testing to ensure adherence to compliance requirements Compliance Culture:Promote Culture: Foster a culture of compliance within the organization, emphasizing ethical behavior and integrity Experience in corporate secretarial and compliance management. preferably from BFSI sector.
Posted 3 weeks ago
2.0 - 6.0 years
2 - 3 Lacs
Madurai, Chengalpattu
Work from Office
Ensure compliance with occupational health and safety regulations Conduct regular inspections, risk assessments, and safety audits Investigate incidents, accidents, and near-misses, and implement corrective actions Maintain safety records and reports
Posted 3 weeks ago
1.0 - 3.0 years
2 - 5 Lacs
Chennai
Work from Office
We are looking for a skilled Auditor to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 1-3 years of experience in the BFSI industry. Roles and Responsibility Conduct audits to ensure compliance with regulatory requirements and internal policies. Identify and assess risks associated with financial transactions and provide recommendations for mitigation. Develop and implement audit plans, test procedures, and control testing protocols. Collaborate with cross-functional teams to resolve audit findings and implement corrective actions. Prepare detailed reports on audit results and present them to management. Stay updated with changes in regulations and industry standards to improve auditing processes. Job Strong knowledge of accounting principles, auditing standards, and regulatory requirements. Excellent analytical, communication, and problem-solving skills. Ability to work independently and as part of a team. Proficiency in Microsoft Office and other relevant software applications. Strong attention to detail and ability to meet deadlines. Experience in conducting risk assessments and developing audit plans.
Posted 3 weeks ago
2.0 - 7.0 years
1 - 5 Lacs
Nagar, Hyderabad
Work from Office
We are looking for a highly skilled and experienced Field Risk Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2 to 7 years of experience in the BFSI industry, with expertise in risk management and analysis. Roles and Responsibility Conduct thorough risk assessments and analyses to identify potential threats to the organization. Develop and implement effective risk management strategies to mitigate identified risks. Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards. Monitor and report on risk performance metrics to senior management. Identify and recommend improvements in risk management processes and procedures. Stay up-to-date with industry trends and developments in risk management. Job Requirements Strong understanding of risk management principles and practices. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environment and prioritize multiple tasks. Strong communication and interpersonal skills. Experience with risk management software and tools. Ability to think critically and make sound judgments under pressure.
Posted 3 weeks ago
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