20 Deviation Management Jobs

Line of Service Advisory Industry/Sector Not Applicable Specialism Risk Management Level Senior Manager Job Description & Summary At PwC, our people in audit and assurance focus on providing independent and objective assessments of financial statements, internal controls, and other assurable information enhancing the credibility and reliability of this information with a variety of stakeholders. They evaluate compliance with regulations including assessing governance and risk management processes and related controls. Those in internal audit at PwC help build, optimise and deliver end-to-end internal audit services to clients in all industries. This includes IA function setup and transformation, co-sourcing, outsourcing and managed services, using AI and other risk technology and delivery models. IA capabilities are combined with other industry and technical expertise, in areas like cyber, forensics and compliance, to address the full spectrum of risks. This helps organisations to harness the power of IA to help the organisation protect value and navigate disruption, and obtain confidence to take risks to power growth. Why PWC At PwC, you will be part of a vibrant community of solvers that leads with trust and creates distinctive outcomes for our clients and communities. This purpose-led and values-driven work, powered by technology in an environment that drives innovation, will enable you to make a tangible impact in the real world. We reward your contributions, support your wellbeing, and offer inclusive benefits, flexibility programmes and mentorship that will help you thrive in work and life. Together, we grow, learn, care, collaborate, and create a future of infinite experiences for each other. Learn more about us. At PwC, we believe in providing equal employment opportunities, without any discrimination on the grounds of gender, ethnic background, age, disability, marital status, sexual orientation, pregnancy, gender identity or expression, religion or other beliefs, perceived differences and status protected by law. We strive to create an environment where each one of our people can bring their true selves and contribute to their personal growth and the firms growth. To enable this, we have zero tolerance for any discrimination and harassment based on the above considerations. Responsibilities Having 4-8 years of work experience in Computer System Validation (CSV), Software Testing and IT Compliance. Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV. Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting. (Preferred exposure to CSV tools such as Valgenesis) Knowledge of GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles. Knowledge of Change Control, Deviation Management, CAPA and Periodic Review. Experience in authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications(URS), Functional Requirement Specifications(FRS), Functional Risk Assessment (FRA) using FMEA, Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR) Mandatory Skills CSV Preferred Skills LIMS/QMS Years Of Experience 4-8 years Education Qualification B.Tech/MBA Education (if blank, degree and/or field of study not specified) Degrees/Field of Study required: Bachelor of Technology, Master of Business Administration Degrees/Field Of Study Preferred Certifications (if blank, certifications not specified) Required Skills Creating Shared Value (CSV) Optional Skills Accepting Feedback, Accepting Feedback, Accounting and Financial Reporting Standards, Active Listening, Analytical Thinking, Artificial Intelligence (AI) Platform, Auditing, Auditing Methodologies, Business Process Improvement, Coaching and Feedback, Communication, Compliance Auditing, Corporate Governance, Creativity, Data Analysis and Interpretation, Data Ingestion, Data Modeling, Data Quality, Data Security, Data Transformation, Data Visualization, Embracing Change, Emotional Regulation, Empathy, Financial Accounting + 32 more Desired Languages (If blank, desired languages not specified) Travel Requirements Not Specified Available for Work Visa Sponsorship No Government Clearance Required No Job Posting End Date Show more Show less

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.,

Schaeffler is a dynamic global technology company with a rich history of private ownership and entrepreneurial spirit. As a partner to major automobile manufacturers, aerospace, and industrial sectors, we offer numerous development opportunities. We are currently looking for a dedicated and detail-oriented Process and Customer Quality Engineer (QMPP) for Schaeffler India Ltd (formerly Vitesco Technologies) at the Pune, Talegaon Plant. This role is crucial in ensuring that our products meet internal specifications and customer expectations. The ideal candidate will lead continuous improvement efforts, manage quality systems, and collaborate with various departments to enhance product and process quality. Your Key Responsibilities include leading systematic problem-solving for internal process rejections, defining and implementing a roadmap to achieve Quality KPIs, working on top issues using a structured approach, planning and executing manufacturing quality audits, leading product-process change management, implementing and improving SPC and MSA, driving adherence of systems in processes, defining the handling of non-confirming parts, leading systematic problem-solving for customer complaints, leading customer process-product-system audits, and improving process and system performance. Your Qualifications should include a Bachelor of Engineering (Mechanical / Electronics) with 7+ years of experience, with a minimum of 6-8 years in the Automotive industry, preferably in Electronics / Mechatronics product manufacturing. Our Offering includes a great company culture, Flexi benefits & Relocation benefits, Health & Life insurance, the opportunity to be a key part of a growing organization, and competitive compensation and benefits. At Schaeffler, we value respect, diversity, and creativity. We believe in treating each other with respect, appreciating differences, inspiring creativity, and driving innovation. By doing so, we contribute to sustainable value creation for our stakeholders and society as a whole. Exciting assignments and outstanding development opportunities await you at Schaeffler as we impact the future with innovation. We look forward to receiving your application. For more information and to apply, please visit www.schaeffler.com/careers. Your Contact: Vitesco Technologies India Pvt. Ltd. Hemanth Hurudi,

Implement & maintain quality systems in compliance with cGMP & regulatory norms.batch review, product release,change control,QA documentation,audits, manage deviations, CAPA,OOS investigations.quality metrics & APQR & regulatory inspection readiness.

As Manager 2 in the Corporate Quality department at SUN Pharma, you will be responsible for overseeing the quality aspects of contract manufacturing organizations (CMOs) involved in manufacturing site transfer products for the US market. Your primary focus will be to ensure compliance with SUN Pharma Quality and Compliance Standards as well as global regulatory requirements. Your essential job functions will include monitoring and overseeing activities at CMO sites to ensure adherence to SUN Pharma standards and regulatory guidance. You will conduct regular oversight visits, prepare visit reports, and serve as the main point of contact for coordination between SUN site, commercial team, corporate quality audit, and CMO site on manufacturing and technical matters. Additionally, you will be involved in authoring and reviewing quality agreements, ensuring the use of qualified service providers, participating in process validation batches, reviewing quality system documents, conducting visits based on market complaints/recalls/CAPA, reviewing batch records, stability data, and analytical reports, as well as preparing and reviewing SOPs. Your role will also include participation in the initial evaluation of CMOs, supporting regulatory audits at CMO sites, engaging in critical investigations, initiating QMS documents, preparing for regulatory agency inspections, participating in product release site audits, maintaining audit-related documents, preparing monthly reports, staying updated on regulations through training, and following Corporate Quality Policies/Global Quality Standards and Regulatory Guidelines. To be successful in this role, you should have an M.Sc./B.Pharm/M.Pharm or equivalent degree along with a total of 10 years of industrial experience and knowledge. You will also be expected to participate in and execute project work assigned by your reporting authority. If you are looking for a challenging opportunity to ensure quality compliance in contract manufacturing organizations and contribute to the overall quality standards of SUN Pharma, this role is ideal for you. Join us in our mission to maintain high-quality standards and regulatory compliance in the pharmaceutical industry.,

As a Process and Customer Quality Engineer (QMPP) at Schaeffler India Ltd (formerly Vitesco Technologies) in Pune, Talegaon Plant, your role is vital in ensuring that our products meet both internal specifications and customer expectations. You will have the opportunity to lead continuous improvement efforts, manage quality systems, and collaborate with various departments to enhance product and process quality. Your key responsibilities include leading systematic problem-solving for internal process rejections, defining and implementing a roadmap to achieve quality KPIs, resolving top issues using a structured approach, planning and executing manufacturing quality audits, leading product-process change management activities, implementing and improving SPC and MSA, driving adherence to systems in processes, defining the handling of non-confirming parts, leading systematic problem-solving for customer complaints related to manufacturing processes, and improving process performance and system performance. To qualify for this role, you should have a Bachelor of Engineering in Mechanical or Electronics with at least 7 years of experience, preferably 6-8 years in the automotive industry, particularly in electronics or mechatronics product manufacturing. In return, we offer a great company culture, flexible benefits, relocation benefits, health and life insurance, the opportunity to be a key part of a growing organization, competitive compensation, and benefits. Our global company values diversity, respect, and innovation, aiming to inspire creativity and drive innovation by appreciating our differences. Join us in advancing how the world moves and impacting the future with innovation. Exciting assignments and outstanding development opportunities await you at Schaeffler. Apply now at www.schaeffler.com/careers and be a part of our dynamic team. Your Contact: Hemanth Hurudi Vitesco Technologies India Pvt. Ltd.,

The Quality Compliance Senior Manager plays a crucial role in the Clinical & Research Quality (CRQ) team for the R&D Quality Organization at Amgen. The CRQ team ensures that research and development activities are conducted ethically and responsibly, meeting the highest standards of quality and compliance to keep patients safe and protect their welfare. This position involves providing leadership to maintain excellence in R&D Quality Processes, mentoring Amgen staff in India, managing day-to-day activities, and ensuring compliance with regulations globally. Additionally, the Quality Compliance Senior Manager will support the digital quality management system (DQMS) and provide end-to-end quality support for managing Quality Incidents/Quality Events, including approving investigations and CAPA plans. Roles & Responsibilities: - Overseeing deviations, audits, and inspections across R&D Quality - Managing the Amgen India R&D Quality team - Facilitating deviation investigations and ensuring documentation within the electronic quality management system - Supporting Global Patient Safety and Global Development teams in inspection management activities - Leading continuous improvement initiatives for CAPA management practices - Collaborating with cross-functional partners to ensure effective processes aligned with industry best practices - Monitoring quality metrics, key performance indicators, and performing root cause trending - Maintaining knowledge of current regulatory and quality practices/issues - Managing archival and retention of audit documentation Basic Qualifications and Experience: - Masters degree with 10-12 years of Pharma and Biotech R&D or commercial manufacturing Quality experience - Continuous Improvement/Change Management experience preferred Additional Competencies/Skills: - Exceptional attention to detail and accuracy - Ability to work independently and proactively in a fast-paced environment - Proficiency in Smartsheet, Microsoft Office Suite, and virtual collaboration tools - Good team building skills and ability to develop employees over time - Familiarity with project management tools and methodologies - Knowledge of GCP, GLP, and/or GPvP - Experience working in a multinational environment - Excellent verbal and written communication skills - Strong problem-solving abilities and adaptability - Collaborative attitude and ability to build positive relationships across diverse teams Amgen ensures equal opportunities for individuals with disabilities throughout the job application process and employment. The company supports professional and personal growth through competitive benefits, a collaborative culture, and comprehensive Total Rewards Plans aligned with industry standards. Join Amgen to make a lasting impact on patient care and your career growth. Apply now at careers.amgen.com.,

Track significant deviations for on time closure and associated CAPAs Preparation of slides for management meetings Scheduling meetings with CFT of all BBL sites Review of non significant investigations

As a Clinical Quality Assurance professional at WPPL, you will play a crucial role in ensuring the establishment, implementation, and maintenance of processes required for the Quality Management System. Your responsibilities will include reporting on the performance of the quality system, planning and executing clinical activities, and conducting various audits across departments. You will be responsible for reviewing equipment installation, qualification, calibration, and preventive maintenance in the clinical department, ensuring compliance with relevant SOPs and guidelines. Additionally, you will review clinical data, pharmacokinetic analysis, statistical output, and statistical analysis reports to ensure accuracy and adherence to protocols. As part of your role, you will conduct external vendor audits, review raw data of clinical projects, and perform internal study audits to assess compliance with GCP/GLP, protocols, SOPs, and regulatory requirements. You will also review and evaluate change controls, deviations, CAPAs, and conduct facility assessments at clinical and pathology laboratories. Collaborating with the Head-QA, you will support regulatory inspections and audits, review responses to queries, and ensure timely implementation of CAPA actions based on investigative results. Additionally, you will update policies, quality manuals, SOPs, and work documents, providing valuable insights and comments for their approval. Your role will involve monitoring studies at external CROs, conducting meetings with clinical and pathology laboratory departments to update on quality systems, and taking on other responsibilities as assigned. With your M.Sc, M.Pharm, or Ph.D. qualification and 8-10 years of experience in Clinical Quality Assurance for BA/BE studies, you will report to the Associate Director Quality Function. Join us at WPPL and be part of a mission-driven team dedicated to making a positive impact on global healthcare by ensuring quality and compliance in clinical activities and processes.,

Company Description LOZEN PHARMA is a contract development and manufacturing organisation specializing in lozenges and throat pops. They offer end-to-end pharmaceutical services from new product development to production and quality control. The manufacturing facilities are GMP certified by WHO, NSF, and SRA bodies. LOZEN PHARMA has a global presence, supplying over 150 products to 35+ countries. Location - Savanur (Hubli) Department - Warehouse / Stores Yrs of Experience - 14+yrs Job Roles & Responsibility - -Ensure procurement of Raw material and Packing material as per production planning and to avoid a stock out situation. -To coordinate with vendors and Production department for timely delivery of raw material & packing material. -To Organize preparation of Goods Receipt Note and intinnation to QC department for timely carnpling and testing of incoming raw rnaterial and packing material. -To ensure that printed packing materials are stored under lock and key. To ensure that !ejected material (RM & PM) are stored in an enclosed area under lock and key. -To ensure that both sampling and dispensing activities are carried out under Reverse Laminar Air Flow. -To ensure that materials are dispensed as per requisition in the presence of QA and production representative and FEFO system for raw materials/FlFO for packing material is followed during dispensing. -To ensure the Standard Operating Procedures (SOPs) prepared by Executive Stores for various stores related activities and arrange the training for same. -To ensure that good documentation practice is followed in stores department. -To ensure that proper inventory of QA released packed product is kept by respective Stores. -To review the change control, deviation, etc. initiated by respective Stores. -To review the material transfer request with respect to any excise related formalities and inform plant head about the excise and any other statutory formalities. -To check the monthly Raw, primary and secondary packing material consumption Statement prepared by respective stores.,

As the Quality Management Systems (QMS) Manager at our corporate departments, you will play a vital role in ensuring the highest standards of quality across all aspects of our operations. Your responsibilities will include reviewing, approving, and closing change controls, deviations, and incidents for the corporate department. Additionally, you will be tasked with reviewing change controls for oral dosage forms across all Hetero formulations facilities. Your role will also involve reviewing Process Validations, Continued Process Verification, Cleaning Validations, Hold time studies, and Annual Product Quality Reviews (APQR) across our formulations facilities. You will be responsible for coordinating and overseeing Quality review meetings, as well as implementing and harmonizing the Quality Management system across all oral dosage form facilities. In this position, you will be in charge of issuing and controlling Critical Quality Attribute (CQA) Standard Operating Procedures (SOPs) for the respective formulation units. You will provide support for regulatory inspections in all formulation units within the Hetero group and conduct self-inspections to ensure compliance with quality standards. You will work closely with your supervisor and be ready to take on any additional responsibilities as assigned. Your role is crucial in maintaining and enhancing the quality standards that define our organization.,

Job Title: ISMS (Information Security Management System) Location: Airoli, Navi Mumbai Key Responsibilities: ISMS Implementation & Management: Develop, implement, and maintain the ISMS framework, including policies, procedures, and guidelines based on ISO 27001 and other relevant standards. Conduct regular risk assessments to identify vulnerabilities and recommend appropriate controls to mitigate information security risks. Coordinate with other departments to ensure adherence to ISMS protocols and align information security with business goals. 2. Compliance & Audits: Ensure the organization complies with regulatory requirements related information security, privacy, and data protection. Lead internal and external audits to assess the effectiveness of the ISMS, manage audit processes, and work towards continuous improvement. 3. Documentation & Reporting: Maintain comprehensive documentation for all ISMS processes, policies, controls, and audit activities. Prepare reports for senior management, detailing the effectiveness of the ISMS and recommending improvements. 4. Continuous Improvement: Monitor industry best practices and emerging security trends to enhance the organizations security posture. Recommend improvements to the ISMS based on audit findings, risk assessments, and new business requirements. 5. Desired Traits: Proactive and self-driven. Ability to work independently as well as part of a team. Strong collaboration and interpersonal skills to engage with stakeholders at all levels. Regards, Yugant Mirajkar Human Resources Kiya.ai

Job Summary 1. Execute Shift Leader routines: 2. Execute LSW Routines and discusses with Production Manager/ Head of Production Segment upon problems and/or deviations in routine fulfilment 3. Identify systematic failures and initiate Problem-Solving measures 4. Coordination, support and coaching of the Line Leader in order to achieve the targets for internal production KPI(PPM, Scrap Rate, OEE ,Rejection Rate, FPY, etc) 5. Performs deviation management to react on abnormalities of targets for Safety eg, incidents; Quality eg, FPY, PPM, Rejection rate; Productivity eg, OEE, line output; Cost: Scrap 7. Ensure data are updated in the frequency as required in the LIB 8. Participates and generates cross functional meetings in case deviations on KPIs. 9. Trigger the support function or apply the escalation plan when ever needed to reach the targets

Job Title: ISMS (Information Security Management System) Location: Airoli, Navi Mumbai Key Responsibilities: ISMS Implementation & Management: Develop, implement, and maintain the ISMS framework, including policies, procedures, and guidelines based on ISO 27001 and other relevant standards. Conduct regular risk assessments to identify vulnerabilities and recommend appropriate controls to mitigate information security risks. Coordinate with other departments to ensure adherence to ISMS protocols and align information security with business goals. Compliance & Audits: Ensure the organization complies with regulatory requirements related to information security, privacy, and data protection. Lead internal and external audits to assess the effectiveness of the ISMS, manage audit processes, and work towards continuous improvement. Documentation & Reporting: Maintain comprehensive documentation for all ISMS processes, policies, controls, and audit activities. Prepare reports for senior management, detailing the effectiveness of the ISMS and recommending improvements. Continuous Improvement: Monitor industry best practices and emerging security trends to enhance the organizations security posture. Recommend improvements to the ISMS based on audit findings, risk assessments, and new business requirements. Desired Traits: Proactive and self-driven. Ability to work independently as well as part of a team. Strong collaboration and interpersonal skills to engage with stakeholders at all levels.

Experienced QA Manager to oversee&manage QA operations our pharmaceutical manufacturing unit.Ideal candidate will ensure compliance with GMP, WHO other regulatory standard,while developing &maintaining QMS Share your Resume to hrd@stedmanpharma.com

Roles and Responsibilities Ensure compliance with regulatory requirements, company policies, and procedures related to production quality management systems (QMS). Develop and maintain documentation for change controls, deviation management, and non-conformance reporting. Collaborate with cross-functional teams to resolve issues related to product quality, process validation, and equipment calibration. Desired Candidate Profile Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma). Minimum 1-4 years of experience in the pharmaceutical industry with expertise in OSD formulation manufacturing. Strong understanding of BMR/BPR regulations and ability to apply them effectively.

Information Security GxP Specialist What you will do Let’s do this. Let’s change the world. In this lead role you will support the GRC Governance / Policy & Audit team working closely with Technology teams to help ensure that GxP controls are in place, GxP deviations are managed and monitored, and security standards are met. The GxP Specialist will assist in owning and maintaining GxP deviation records, performing GxP assessments, managing controlled documents, and supporting regulatory compliance efforts. Roles & Responsibilities: GxP Governance Leadership: Support the GRC organization in leading a team of GxP and/or policy analysts performing tasks related to governance, GxP deviation management, document management, and policy exception processes. GxP Deviation and CAPA Management : Manage and own technology related GxP deviations, CAPA, and CAPA-EV records Manage GxP reporting and monitoring metrics for Technology/IT records Collaborate with record owners and QA to ensure timely record resolution Assist in the identification and evaluation of risks associated with GxP deviation records. Identify and support new record owners across IT/Technology (e.g. office hours, ad-hoc meetings, document management support). Attend enterprise network meetings as needed to represent the Technology / IT function. GxP Deviation Monitoring and Improvements: Recommend deviation management improvement strategies across Technology/IT. Collaborate with Quality, IT application, cybersecurity, and business teams to supervise and resolve identified risks and vulnerabilities associated with deviations and CAPA’s. Assist in conducting CAPA applicability assessments, time studies, and related initiatives to identify impacts and improvement opportunities in IT systems, processes, and policies. Supervise, monitor, and report on the efficiency of existing GxP records, trends, and recommend improvements as needed. Governance and Regulatory Support: Ensure compliance with relevant industry standards and regulatory requirements (e.g., GxP, GDPR, SOX, NIST). Assist in proactive measures to facilitate compliance, such as collaborating with stakeholders to initiate periodic reviews Assist in the preparation for audits and inspections by internal and external parties, providing documentation and evidence of IT GxP deviation management practices. Support the development and implementation of IT governance, risk, and compliance frameworks and continuous improvements. Support the development and implementation of IT governance, risk, and compliance policies as well as supporting documentation, and their continuous improvements. Track and monitor document reviews, and support document owners to ensure timely periodic review completion. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The GxP security professional we seek is collaborative and action-oriented with these qualifications. Basic Qualifications: 5+ years of experience in IT GxP deviation management, IT quality management, IT auditing, or information security. Hands-on experience with deviation management tools and associated frameworks (e.g., ISO 27001, NIST, COBIT). Master’s degree and 4 to 6 years of information technology, Cybersecurity, Risk Management, or a related field experience OR Bachelor’s degree and 6 to 8 years of information technology, Cybersecurity, Risk Management, or a related field experience OR Diploma and 10 to 12 years of information technology, Cybersecurity, Risk Management, or a related field experience Preferred Qualifications: Good understanding of GxP deviation management, controlled document management, IT infrastructure & systems, and security standard methodologies. Ability to assess technical and business risk related to information systems. Excellent problem-solving, analytical, and communication skills. Ability to communicate complex GxP and risk concepts to non-technical collaborators. Familiarity with regulatory frameworks and compliance standards (e.g., GxP, GDPR, HIPAA, SOX). Technical Knowledge : Proficiency with GxP deviation management tools, GRC (Governance, Risk, and Compliance) software, controlled document management tools, enterprise change management tools, and security incident management tools. Experience with security controls related to networks, databases, and cloud environments. Soft Skills: Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Drive compliance requirements, deviation tracking, raise issues to senior management, collaborate with cross-functional teams, work on Projects, train employees on compliance policies, analyze the activities and identify risk of non-compliance.

Role & responsibilities 1. To ensure GMP compliance on shop floor. 2. To follow SOPS and policies and perform tasks as per the SOP. 3. To perform investigation along with CFT to identify the root cause. 4. To participate in the preparation and review of investigation report for OOS, OOT, product quality complaints and unplanned deviations related to manufacturing. 5. To initiate change controls, planned deviations and unplanned deviations related to production department. 6. To provide the awareness training and SOP related trainings to concern personnel. 7. To develop skills in subordinates by motivation and on the job training. 8. To coordinate with internal and external auditor along with CFT. 9. Drafting of investigation for OOS, OOT, product quality complaints and unplanned deviations related to manufacturing. To prepare review and timely compliance of audit related observations of production department . Preferred candidate profile B.Pharma / M.Pharma candidate having regulatory exposure of handling QMS systems in pharma industry and sound knowledge technical knowledge as well as good communication skills. candidate must possess 5 to 10 yrs experience in handling QMS process and must have worked in the past in Quality/Manufacturing function.

Role Summary: OSD Production QMS is responsible for ensuring adherence to quality standards within the production process. The role involves monitoring production activities, implementing quality control measures, maintaining compliance with regulatory requirements, and driving continuous improvement initiatives. Roles And Responsibilities Quality Compliance: Implement and monitor compliance with QMS standards Industry-specific standards. Conduct periodic audits of production processes to identify deviations and enforce corrective actions. Ensure all production processes align with regulatory and company quality standards. Documentation & Reporting: Maintain and update standard operating procedures (SOPs), work instructions, and quality records. Prepare detailed reports on quality performance, including non-conformance incidents and corrective actions taken. Process Improvement: Analyze production workflows and recommend improvements to enhance efficiency and quality. Participate in root cause analysis for production issues and implement preventive measures. Key Skills and Competencies: In-depth knowledge of Quality Management Systems and standards. Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities. Proficiency in using quality management tools and techniques. Familiarity with relevant USFD, EU, TGA regulatory requirements and industry best practices.