676 Change Control Jobs

Job description Production Department: Assisting in the operation of machinery and equipment as per SOPs. Helping in the batch manufacturing process under supervision. Following cGMP (current Good Manufacturing Practices) guidelines. Maintaining cleanliness (Good Housekeeping) in the production area. Recording batch manufacturing details accurately in logbooks. Supporting preventive maintenance activities. Ensuring proper handling of raw materials and finished goods. Quality Assurance (QA) Department: Assisting in review of batch records and documentation. Supporting deviation, change control, and CAPA tracking. Participating in internal audits and self-inspections. Learning about regulatory compliance and documentation practices. Preferred candidate profile B.Pharmacy / M. Pharmacy Fresher Location - Zahirabad

General Information Country: India State: Maharashtra City: Chakan, Pune Office Location: Gat No. 428, Taluka - Khed, Mahalun - Unit No. 1A, Building No. 4B - Indospace Rohan Industria - - - Date posted: 09-Jul-2025 Business Function: Manufacturing/Operations Position Type: Full-Time/Regular Description Why This Role is a Great Opportunity Join a forward-thinking engineering team in Pune where your technical expertise and attention to detail will directly contribute to the development and delivery of high-quality products. This role offers the opportunity to work with cross-functional teams, enhance your SAP and CAD skills, and play a key role in driving data accuracy and process efficiency. Who You Are You are a proactive and detail-oriented engineering professional with a strong foundation in mechanical design and a solid grasp of SAP systems. You enjoy solving problems, managing data, and collaborating across departments to ensure smooth product development and order fulfillment. Minimum Qualifications Why This Role is a Great Opportunity Join a forward-thinking engineering team in Pune where your technical expertise and attention to detail will directly contribute to the development and delivery of high-quality products. This role offers the opportunity to work with cross-functional teams, enhance your SAP and CAD skills, and play a key role in driving data accuracy and process efficiency. ________________________________________ Who You Are You are a proactive and detail-oriented engineering professional with a strong foundation in mechanical design and a solid grasp of SAP systems. You enjoy solving problems, managing data, and collaborating across departments to ensure smooth product development and order fulfillment. ________________________________________ Desired Skills And Experience Experience in product data management and change control Familiarity with manufacturing documentation and drawing standards Strong analytical and problem-solving abilities Customer service orientation and ability to work cross-functionally Knowledge of regional (Asia Pacific) product and service offerings is a plus ________________________________________ What You Will Be Doing Create, validate, and maintain product data structures in SAP to support manufacturing and customer specifications Manage special order requests, including BOM and routing creation in SAP Analyze and resolve data-related issues, ensuring accuracy and consistency across systems Collaborate with factories and internal teams to address database and specification concerns Compile and maintain up-to-date manufacturing documentation, including technical drawings Desired Skills And Experience Customer Service Orientation Must be a good Team player Decision making ability Good communication skills and presentation skill Strong ability to analyze, conceptualizes, and logically organizes database information with high degree of precision and accuracy Knowledge of problem solving tools and techniques Knowledge of Excel and VBA. What You Will Be Doing Why This Role is a Great Opportunity Join a forward-thinking engineering team in Pune where your technical expertise and attention to detail will directly contribute to the development and delivery of high-quality products. This role offers the opportunity to work with cross-functional teams, enhance your SAP and CAD skills, and play a key role in driving data accuracy and process efficiency. ________________________________________ Who You Are You are a proactive and detail-oriented engineering professional with a strong foundation in mechanical design and a solid grasp of SAP systems. You enjoy solving problems, managing data, and collaborating across departments to ensure smooth product development and order fulfillment. ________________________________________ Minimum Qualifications Bachelors Degree in Engineering (preferably Mechanical, Manufacturing, or Automobile) 57 years of relevant experience in a design or engineering support role Proficiency in SAP (PP/MM modules); SAP Consultant Certification is a plus Strong CAD software skills and understanding of mechanical design principles Excellent communication, planning, and time management skills ________________________________________ Desired Skills and Experience Experience in product data management and change control Familiarity with manufacturing documentation and drawing standards Strong analytical and problem-solving abilities Customer service orientation and ability to work cross-functionally Knowledge of regional (Asia Pacific) product and service offerings is a plus #associate #Design #Engineering #Manufacturing Show more Show less

The role involves planning and resource allocation for routine operations within the analytical development function. You will be responsible for ensuring timely analysis of finished products and raw materials for various projects. Your duties will include reviewing analytical data, raw data, daily usage logbooks, and lab notebooks to support operations. You will also be involved in preparing and reviewing critical documents such as Analytical Method validation protocols, reports, method transfer protocols, and Standard Operating Procedures (SOPs). Additionally, you will conduct literature searches and provide guidance on new method development. Another key aspect of the role is to review data for stability studies and ensure timely analysis of samples. You will need to identify resource needs and initiate procurement to prevent delays in project deliverables. Supporting product technology transfers and ensuring compliance with safety measures will also be part of your responsibilities. In terms of quality management, you will be required to raise change controls, ensure data integrity, and adhere to Good Manufacturing Practices (GMP). You will also handle documentation related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and Occupational Health & Safety Assessment standards. As part of your job authority, you will review analytical data, plan and allocate resources, prepare and review SOPs, and technology transfer documents. You will also review calibration data, logbooks, and lab notebooks, as well as identify and report any near misses, hazards, or unsafe conditions. Other responsibilities include implementing QEHS policies and objectives, ensuring the use of personal protective equipment (PPE) during operations, and managing incidents and non-conformities effectively. You will also oversee work permit systems during maintenance activities and ensure proper waste disposal procedures are followed.,

The IT Manager (APAC) will report to the Global IT Operations Director and be responsible for overseeing the IT Department operations in the APAC region to ensure alignment with global and local business objectives. You will be tasked with planning, coordinating, directing, and designing IT-related activities, as well as providing administrative support for daily operational tasks. Collaborating with decision makers in various departments and Global IT, you will identify, recommend, develop, implement, and support cost-effective technology solutions across the business. Your responsibilities will include leading the day-to-day management and operational planning of the Regional IT Function, managing IT systems deployment, monitoring, maintenance, and support, analyzing and recommending improvements for the IT infrastructure, overseeing end-user services, defining business and systems requirements, managing financial aspects of the IT Department, and ensuring compliance with IT policies and procedures within the region. You will also be involved in vendor and contract management, asset management, IT staffing, and maintaining communication with executives and end-users regarding IT activities. Operationally, as the Regional IT Manager, you will monitor systems performance, resolve issues, manage hardware and software purchases and installations, act as a project manager for IT infrastructure projects, ensure IT support for all users, maintain technology standards, and manage IT team activities. You will also negotiate 3rd party technology contracts, ensure IT resources are skilled, support business systems teams, and ensure the deployment and support of global business systems. The ideal candidate for this role should have extensive experience in managing international IT projects, preferably within an international business environment with an IT operational or manufacturing background. Strong communication skills, multitasking abilities, knowledge of Change Control and Document Management processes, and proficiency in Microsoft Office products are essential. Fluency in English and Indian languages is required, and familiarity with ERP, CRM, BI, and Microsoft products like Dynamics NAV / Business Central, SharePoint, and Teams is desirable. Creativity, effective team leadership, ability to work well under pressure, and innovation in problem-solving are key attributes for success in this role. You should be able to collaborate with internal teams, external vendors, and senior-level stakeholders, build rapport and trust with the IT team and business, and lead by example while fostering team culture and commitment. Some regional and global travel may be required for this role to offices and manufacturing plants.,

As a Senior Analyst in R&D Compliance Specification at Kimberly-Clark, you are a dedicated learner and a natural leader who takes initiative to improve processes and engage others in the journey. Your commitment to integrity and quality is unwavering, ensuring that your responsibilities contribute to long-term success. By joining our team, you will play a crucial role in enhancing healthcare for billions of individuals worldwide, starting with your efforts. Reporting to the R&D Center of Excellence Leader, you will be an integral part of the EM R&D Team. Your main responsibility will be to ensure that all products and processes adhere to regulatory standards and internal specifications. This entails developing, implementing, and maintaining compliance programs while managing product specifications to uphold quality and consistency within the Kimberly-Clark Quality Management System. Your role is vital in supporting business objectives and embodying the One K-C Behaviors and values. Key responsibilities include developing and implementing compliance programs to meet regulatory requirements, overseeing design control activities to ensure products align with regulatory and quality standards, managing change control processes, harmonizing procedures to promote efficiency, monitoring internal processes for compliance, and maintaining product specifications. Additionally, you will collaborate with cross-functional teams, conduct training sessions on compliance practices, stay updated on regulatory changes, prepare compliance reports, investigate issues, and support audits. In this role, you will act as a liaison between the R&D and Quality departments, collaborate with Quality Assurance teams, conduct training sessions, and facilitate process harmonization initiatives. You will also be responsible for monitoring internal processes to ensure compliance with industry standards and regulations. Your ability to build collaborative relationships, drive solutions, and maintain integrity in all communications is essential to succeed in this position. Based in Ho Chi Minh City, Vietnam, you will work in manufacturing facilities, where you may be exposed to various environmental conditions. Proper personal protective equipment must be worn at all times to ensure safety. Your commitment to self-development, collaboration, and integrity will be key to thriving in this dynamic role. To qualify for this position, you should hold a Bachelor's degree in a relevant scientific field and have at least 3 years of experience in compliance management, quality assurance, or a related field. Strong knowledge of regulatory requirements, attention to detail, organizational skills, analytical abilities, effective communication, and proficiency in compliance management tools are essential skills for success in this role. At Kimberly-Clark, we offer a range of benefits to support your health, well-being, and professional development. From medical, dental, and vision coverage to flexible savings accounts and diverse income protection options, we prioritize your holistic well-being. Additionally, we provide support for educational pursuits, childcare, and other personal needs to ensure a fulfilling work experience. If you are ready to contribute to a global leader in healthcare and consumer products, click the Apply button to start the application process. We look forward to reviewing your qualifications and exploring the potential fit for this role. For more information about careers at Kimberly-Clark, visit our website. In conclusion, this role offers you the opportunity to be part of a team dedicated to innovation, growth, and impact. With a focus on sustainability, inclusion, and career development, Kimberly-Clark provides a supportive environment where you can make a meaningful difference in the world. Join us on this exciting journey of purpose-driven performance and growth.,

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas. Following a new opportunity, we are currently looking for a Junior Consultant: Qualification & Validation (CQV) to join our team in an onsite project at Rupnagar (Chandigarh) Location. The ideal candidate should have 2+ years of experience in a similar role and be able to review and update P&ID, prepare Qualification Documents like Validation Plan, Design Qualification, User requirement specification, Installation Qualification, Operational Qualification, Performance Qualification, System impact assessment, Functional Risk Assessment, Qualification summary report, Standard Operating Procedure (SOP), Change Control, and drafting DCS-PLC Process write up. The candidate should also be willing to travel and relocate as per project requirements anywhere in India and global locations after the project completion. An immediate joiner is required (20 Days). Location: Rupnagar (Ropar) - Punjab, near Chandigarh. As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group offers you the opportunity to work on international projects, enhance your skills, and engage with colleagues from around the world. If you are seeking a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.,

Date: 2 Jul 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Job Description Job Title: QMS Project Reviewer Job Location: Syngene International Limited, Bengaluru About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Core Purpose Of The Role This is an exciting opportunity to play a role in drug substance development and manufacturing of Syngene. The role will provide exposure to handling clients across the globe, interaction with cross-functional departments and activities involved from product introduction to discontinuation. It provides an opportunity to learn different aspects of product development to commercial manufacturing. Role Accountabilities Follow GMP, GDP, and GLP procedures as applicable, while performing the assigned task. Create/ revise/ review of procedures (like SOP, protocols, calibration schedule, and other related documents as applicable.). Review and approval of Master BMR and PDR and its compliance. Review of TTD related to Late phase and commercial. Responsible for issuance and control of BMRs, PDRs, SOPs, EOPs and ECCs.Verify the product details, batch no., quantity, label, purchase order, RM issue slip, CoA, weights, packing and dispatch record, packing area (not limited to) and provide clearance to dispatch activity. Assessment of SOP vs guidelines for any gaps and taking appropriate actions. Investigate, review of investigation with respect to OOS/OOT and involve in the identification of root cause and to propose the CAPA for identified root cause. Preparation and review of QMS Trends (Deviation, LIR, OOS, OOT, Change control & Complaints). Handling of returned products and product recall. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience Demonstrated Capability Education Experience 3 - 6 years into Project related QMS activities (Change control, Deviations, CAPA, OOS, LIRs) Must have handled clients Expertise in review of Master Batch Record, Batch Record and Analytical Documents Knowledge on Good Documentation and laboratory practices Good coordination among CFTs Skills And Capabilities Expertise in handling QMS Activities Good knowledge about project related activities Client handling experience Master Batch Record, Batch Record and Analytical Document Review skills Specification and Method of analysis review Good communication skills Education MSc. Chemistry Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Show more Show less

The C&P Transformation Portfolio Management Office (PMO) Lead supports the Customer & Products (C&P) Leadership team in steering the delivery of business transformation towards an Integrated Energy Company. Reporting to the VP Cost Transformation, you bring clarity and execution to all transformation programs and cost initiatives across the C&P businesses. Collaborating with various stakeholders, you build coordinated timelines, reports, and risk overviews to advise on progress and support prioritization and risk management. Data-driven insights and challenge to the delivery of cost savings targets are key responsibilities. You will coordinate inputs from C&P business units and Enablers into transformation plans, lead monthly reporting into GTO, maintain action plans, set up program metrics, and act as a central hub for process standardization between program PMOs. Your role involves portfolio program management, strategic and data analysis, and project plan creation and management. Requirements include a University-level degree, commercial competence, program management experience on global programs, senior customer management evidence, and deep experience in at least one C&P business. Comfort with ambiguity, strong impact and influencing skills, strategic insight, excellent communication, self-organization, digital proficiency, project management, financial skills, and adaptability to changing business environments are necessary. Your values should include building positive relationships, listening carefully, pursuing detailed management, upholding BP's rules and standards, doing the right thing based on guidelines, speaking out when necessary, and being resilient. Up to 10% travel may be required, and the role is eligible for relocation within the country. Remote working is not available for this position. Key Skills: - Change control, Conflict Management - Commissioning, start-up, and handover - Design development and delivery, Quality - Governance arrangements, Risk Management - Performance management, Schedule and resources - Portfolio Management, Stakeholder Management - Project and construction safety, Strategy and business case - Project Leadership, Supplier Relationship Management Legal Disclaimer: Employment may be contingent upon adherence to local policy, including drug screening, physical fitness review, and background checks based on the role you are selected for.,

The responsibilities for this role include reviewing raw and finished product specifications, ensuring good laboratory practices in the Quality Control department, reviewing audit trial records, analyzing analytical records, reviewing instrument calibration and equipment qualification documents related to QC, validating analytical methods, verifying samples, handling reserve sample room, ensuring analyst qualification, reviewing working standards, managing deviations, change control, OOT, OOS, laboratory incidents, investigations, and annual trends, coordinating CAPA implementation verification and closure, reviewing instrument and equipment preventive maintenance, monitoring and recording temperature and humidity in the laboratory area, and managing document control. The ideal candidate should possess skills in audit trial, OOT, deviation handling, OOS, backup and restoration data management, sample handling, instrument maintenance, quality assurance, instrument calibration, laboratory practice, laboratory incidents management, change control, method edit forms, working standards review, analytical records analysis, quality control, document management, equipment qualification, stability protocols, analyst qualification, analytical method validation, CAPA implementation, and temperature monitoring.,

The ideal candidate for this role should have 6-10 years of experience and possess the following competencies: - Punctual with a proven track record of dedication and reliability. - A team player who is equally capable of working alone. - Fluent in both written and spoken English. - Knowledge and experience in peptides Quality. - Reviewing the Batch Manufacturing Records. - Executing and Monitoring Process Performance Qualification (PPQ). - Preparing Cleaning Validation Protocol and Monitoring Cleaning Validation/Verification activities. - Reviewing the SOPs, Validation, and Qualification Record. - Handling Dispatch and Line clearance activities. - Preparing Annual Product Review. - Initiating various QMS elements like change control, deviation, CAPA, etc. - Investigating Customer complaints, Return Goods, Recall. - Reviewing Reprocessing and Reworking. The key stakeholders for this position include the QA Team and other departments in the plant. The reporting structure for this role is to the QA Head.,

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview Reporting to a Portfolio Manager the position holder will have primary responsibility for delivery of a series of Product Development Projects within the Relays Product Group. The Senior Project Manager is a prominent Project Management role with TE and the position holder will drive the successful performance of multiple high profile/value projects following defined methods and processes to achieve commercial and efficiency targets set by the business Developing relationships and maintaining a high-level of communication with cross-functional global teams will be critical to the role. You will be required to act as the primary owner of each project and to report progress to a senior leadership team on a regular cadence and at specific key Milestones during each Project. Job Requirements The typical activities of the position will cover: All aspects of Project Management from project inception to completion Working with global multi-disciplinary teams to engineer and manufacture relay products in a regulated environment Managing and being accountable for a project budget, liaising with procurement to ensure timely acquisition of goods and materials Risk Management and leadership of Risk Assessment activities Development of the Project Business Case alongside the Business Office Defining all necessary requirements for the Relay Product(s) being developed by the project. Reporting on Project status and being accountable for project progress against the Plan Escalation of issues as applicable and utilisation of project change controls Liaising with customers and suppliers global Initial Priority Primary project work for the first two-to-three years will be factory migration and re-qualification efforts for multiple relay product lines. The TE New Product Development process will be followed. You will be expected to cross-check to global PMO to ensure process adherence and also to global engineering teams to facilitate peer-review of design changes. Required Skills The ideal candidate will have eight or more years proven experience of leadership through multiple projects including those within a regulated field. They will have a track record of successful delivery of customer-facing hardware development projects following a Stage Gate process in a product development / manufacturing environment. Key Requirements Excellent written and spoken English Strong interpersonal, negotiating and influencing skills and the ability to build strong, credible relationships with multiple organisation functions (internal and external) Able to take ownership of each project and drive good decisions in a non-matrixed leadership position to deliver results Clear strategic thinker with the ability to execute on priorities Self-motivated with the ability to perform in a demanding environment Strong communication, negotiation, and presentation skills including at senior levels Excellent organisational, time management and administrative skills Good level of IT capability with detailed experience of Microsoft Office (MS Project, Excel, PowerPoint, Word) Other Beneficial Requirements Project Management Professional (e.g. PMP, Prince 2) A professional level of business acumen and good commercial understanding Results driven The ability to tailor critical information and communication to different audiences Experience with Planisware Technical and commercial education/experience related to Engineering and/or Manufacturing in a similar regulated industry Competencies SET Strategy, Execution, Talent (for managers)

Agivant Technologies is looking for Software Technical Writer (Lucknow) to join our dynamic team and embark on a rewarding career journeyWriting, editing, and proofreading technical documentation, including user manuals, product specifications, and process documentation.Collaborating with cross-functional teams, to gather information and ensure accuracy of technical documentation.Conducting research and gathering information from subject matter experts to develop technical documentation and other materials.Organizing and managing documentation, including updating and maintaining document libraries and version control systems.Creating and maintaining templates, style guides, and other documentation standards to ensure consistency and clarity of technical documentation.Ensuring technical documentation meets regulatory and compliance requirements.Publishing technical documentation in various formats, including online help, PDFs, and printed materials.Should have excellent writing and editing skills, as well as strong attention to detail and the ability to explain complex technical concepts in clear and concise language.Strong research and analytical skills.

Shaan Energy is looking for Testing & Commissioning Engineers to join our dynamic team and embark on a rewarding career journey Analyzing customer needs to determine appropriate solutions for complex technical issues Creating technical diagrams, flowcharts, formulas, and other written documentation to support projects Providing guidance to junior engineers on projects within their areas of expertise Conducting research on new technologies and products in order to recommend improvements to current processes Developing designs for new products or systems based on customer specifications Researching existing technologies to determine how they could be applied in new ways to solve problems Reviewing existing products or concepts to ensure compliance with industry standards, regulations, and company policies Preparing proposals for new projects, identifying potential problems, and proposing solutions Estimating costs and scheduling requirements for projects and evaluating results

Must have minimum 4 years experience in QMS activity Issuance and management of QMS Forms (e.g., CC, CAPA, Deviation, etc.) Participate in the evaluation and investigation of quality-related issues Coordinate with cross-functional teams (CFT) and relevant stakeholders for issue resolution Review and compile supporting documents for QMS processes Maintain and update QMS log registers Ensure proper documentation and records management of QMS activities Perform artwork review to ensure compliance with quality standards Job Location: Kadi, Gujarat ( Bus facilities are available) Note: Immediate joiners will be preferred first

Seeking a CSV Consultant to work on a variety of validation projects including manufacturing systems, lab systems, risk assessments, etc. Some of the work may be done remotely, some at client sites and others at one of our offices. Immediate start date Job Responsibilities: Responsible for the Computer System Validation processes of the company Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11) Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule Lead system qualification efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply Minimum Requirements: Minimum degree requirement - Bachelor's degree with at least 10+ years of experience Must be willing to travel regionally and/or nationally throughout India Candidates must have excellent verbal communication and technical writing skills Experience in generation and execution of protocols and procedures related to different areas of qualification and validation Expertise in ISPE GAMP5, ICH Q8, ICH Q9, ICH Q10, 21 CFR Part 11, Computerized System Validation, Equipment Qualification, and Validation Change Control Working knowledge of protocol development for validation of complex computer systems (e.g., multiple GAMP classes of systems); ability to develop Installation, Operational, and Performance Qualification documents Experience in execution of system validation lifecycle deliverables Experience in project execution within at least one area of systems validation (e.g., laboratory equipment, facilities utilities, manufacturing equipment) Proficient in Microsoft Word, Excel, Power Point, and Project Ability to plan and manage own work All candidates must be legally eligible to work in India

**Job Description:** As a CSV Lead in the Drug Safety domain, you will be responsible for overseeing the validation process of safety systems, including but not limited, or other drug safety databases. You will lead cross-functional teams and manage CSV lifecycle activities, including planning, executing, and documenting validation efforts for drug safety systems. **Key Responsibilities:** - Lead validation efforts for drug safety systems such other similar platforms, ensuring compliance with industry standards (21 CFR Part 11, GxP, and other relevant regulations). - Develop, review, and approve validation documentation, including Validation Plans, Protocols, Reports, and Traceability Matrices. - Perform risk assessments and impact analysis of software changes or upgrades to ensure compliance with validation requirements. - Collaborate with cross-functional teams (IT, Quality Assurance, Pharmacovigilance, and Compliance) to ensure effective implementation and maintenance of validated systems. - Provide guidance and training on validation processes and regulatory requirements. - Support audits and inspections related to CSV activities and respond to findings or inquiries from regulatory bodies. - Manage the CSV lifecycle, including requirements gathering, testing, and system releases for safety systems. - Ensure that all system-related issues are identified, tracked, and resolved in a timely manner. **Qualifications:** - Bachelor's degree in Computer Science, Life Sciences, or a related field (or equivalent experience). - Minimum of 2years of experience in Computer System Validation, with a focus on drug safety systems (Argus, ArisG, or similar). - In-depth knowledge of pharmaceutical and regulatory requirements, including 21 CFR Part 11, GxP, and ICH guidelines. - Strong experience in system validation and lifecycle management of computer systems, including testing, documentation, and quality assurance processes. - Familiarity with the pharmacovigilance domain and the processes for adverse event reporting and management. - Excellent communication and leadership skills with the ability to work in cross-functional teams. - Experience with audit readiness and regulatory inspections (FDA, EMA, etc.) is a plus. - Certification in Computer System Validation or related fields is a plus.

Walk-In Drive for Development Quality Assurance - Formulation Department @ MSN R&D Center Pashamylaram on 02.08.2025 (Saturday ) Roles & Responsibilities 1. Issuing of Batch Manufacturing Records, Analytical Raw datas and maintaining the respective log books. 2. Issuing of registers and formats for all departments and maintaining of records for issuance and reconciliation. 3. Issuance approval, Issuance and Retrieval of the documents in eDMS. 4. Receiving, Issuing and reviewing the bio batches related executed Batch Manufacturing Records, Analytical raw datas and archiving. 5. Responsible for review of product development documents and analytical documents related to technology transfer. 6. Preparation and review of departmental SOPs 7. Reviewing of Equipment qualification protocols and Reports. 8. Review of supplier qualification documents. 9. Review of calibration documents 10. Receiving and reviewing of executed raw datas & ATRs and archiving for bio batches. 11. Reviewing of analytical method validation protocols & reports. 12. Maintenance, Retrieval and Archiving of all GMP related documents and records. 13. Preparation & review of department Schedules 14. Responsible for document distribution to the user departments. 15. Responsible for Document control activities. 16. Responsible for preparation, review and submitting License Applications. 17. Handling of Change controls (Permanent and Temporary), OOS and Incidents. 18. Responsible for approval of documents in absence of Head FDQA. 19. Responsible for performing job assigned by Head FDQA or his authorized designee. Note : Formulation R&D Candidates also eligible Position : Executive / Senior Executive Qualification : M Pharma / B Pharma Only. Work Location : MSN R&D Center, Pashamylaram. Department : Development Quality Assurance - Formulation Department. Experience : 2 to 8 Years Date of Interview : 02.08.2025 (Saturday ) Interview Time : 9.00 AM to 3.00 PM Venue Details : MSN Laboratories Pvt Ltd. MSN R&D center, Pashamylaram , Isnapur, Patancheru, Sangareddy - 040-30438786

Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. In BD Specimen Management (SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing you to broaden your expertise and grow in your career. Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Our people make all the difference in our success. Join us in our mission to advance the world of health. Support the Regulatory Affairs function on Product Lifecycle Management (PLM)/Sustaining project teams and liaise with Regulatory Affairs subject matter experts (SMEs) to fulfill US FDA and EU CE requirements. Assist in compiling, drafting and submitting the required submission documents to support 510(k) and/or CE Technical File Documentation, (eg STeD ) to obtain clearances and/or approvals to established timelines. Assist and manage Notification of Change (NOC)/International Regulatory Affairs assessments of PLM/Sustaining activities to ensure regional/country requirements of US, EU and Rest of World (ROW) are captured in Regulatory strategy development. Develop regulatory strategies for Change Controls (CC) and establish Regulatory Requirements. Monitor completion of all CC task requirements recorded in the PEGA CC system and verify completion of requirements before Engineering Change Release ECRO release. Monitor and assess the impact of existing, modified and new standards pertaining to BD products for the US and EU markets and maintenance of related regulatory documentation. Support regulatory efforts to maintain and /or simplify technical documentation maintenance, labeling changes/remediations projects and UDI assessments. Review and approve labeling and promotional material for compliance to FDA and EU regulations. Support completion of EU Substantial Change Notifications and Substantial Change Applications for approval. Prepare responses to notified body inquiries. Prepare EU CE re-certification applications following notified body templates with supporting evidence from cross functional teams. Provide training or deliver presentations to cross-functional groups across TCI and SM on salient regulatory topics. Recognize potential compliance problems areas or associate ambiguity and make recommendations to resolve. Work independently and carries out the above tasks with minimal supervision. Education and Experience: B.S. degree in a scientific, health sciences or technical discipline (e.g., engineering, bioengineering, biology, chemistry). Minimum 5 years regulatory experience and working knowledge in regulated medical device or in vitro diagnostic device companies or an equivalence combination of experience with an advanced degree. Experience in preparing, approving and maintaining Technical Documentation and other submissions compliant with US, EU and global regulations. Experience in supporting product development projects for product and process changes. Demonstrated ability to participate on cross-functional team to consistently to meet regulatory requirements and project timelines. Proficient in using Microsoft Word, Excel, PowerPoint, and Project. Strong communication (written, oral) and project management skills. Able to handle multiple competing tasks with great attention to detail. Able to work independently to achieve objectives on or before schedule. Demonstrated cross-functional collaboration and teamwork skills including influencing without authority. Comprehensive knowledge of medical device regulations and standards. Current knowledge of European quality system standards, and requirements under EU MDR and IVDR preferred. Ability to navigate ambiguous regulatory requirements and standards interpretation.,

As the Head of Corporate Quality in the Global Supply Organization at our base location in Navi Mumbai, India, you will play a crucial role in leading the development and execution of quality assurance strategies that are in line with our company's long-term objectives. Working closely with the Chief Technology Officer and the GSO Leadership Team, you will be responsible for ensuring the implementation of robust quality management systems, regulatory compliance, and driving continuous improvement in operational performance. Your responsibilities will include establishing best-in-class quality goals, analyzing quality metrics trends, implementing problem-solving strategies and system enhancements to achieve the desired levels of quality. You will lead and oversee the quality teams across all manufacturing facilities, focusing on continuous improvement initiatives. Team building will be a key aspect of your role, where you will be involved in establishing, inspiring, training, mentoring, and managing a team of QA professionals to adapt to new processes and tools effectively. Collaboration with business units to set quality targets for new and existing products, managing quality projects resulting from site consolidations or acquisitions, and working with the Quality Management System group to streamline and harmonize quality systems will also be part of your responsibilities. You will be responsible for maintaining the effectiveness of the Quality System across all Shalina manufacturing sites and Contract Manufacturing site, as well as implementing and monitoring an effective Vendor/Supplier development process. You will lead recruitment activities, ensure the professional development of direct reports and the overall company quality organization, and establish standards and metrics to support exponential growth while adhering to quality standards and regulatory guidelines. Additionally, your role will involve participating in various functional meetings, such as Supply Chain, Operational Excellence, and Sourcing, R&D. Your essential qualifications and experience include a degree in M.Pharm/B.Pharm/Master's in science, along with 15+ years of leadership experience in quality assurance, preferably in the pharmaceutical or life sciences industry. You should possess a strong understanding of ROW regulatory landscapes and international quality standards, exceptional commercial acumen, strategic business insight, and excellent consulting and communication skills to influence senior stakeholders effectively. Moreover, you should demonstrate personal credibility, strong interpersonal skills, integrity, dependability, and a results-oriented approach. Experience in working cross-culturally and cross-functionally with diverse colleagues is essential for this role. Your responsibilities will also include providing training efforts at Shalina sites as needed, advising and supporting alliance partners/service providers/central distribution center to ensure compliance with quality requirements, and offering immediate support during audits and compliance checks. In summary, as the Head of Corporate Quality, you will lead the development and execution of quality assurance strategies aligned with the company's goals, ensuring regulatory compliance, continuous improvement, and effective quality management systems across manufacturing facilities. Your role will involve team building, collaboration with business units, and maintaining compliance with global quality standards while supporting growth and customer satisfaction.,

As a Configuration Manager at our development and engineering project team, you will play a critical role in maintaining configuration control over software and system components. Your responsibilities will include developing and implementing configuration management processes, policies, and tools to ensure the integrity, security, and traceability of all configuration items (CIs) throughout the project lifecycle. You will be tasked with planning and maintaining a configuration management (CM) plan for the project, outlining procedures to control CIs. It will be your responsibility to oversee version control of all software artifacts, ensuring correct versions are used across different environments. You will define and establish baselines for code, documentation, and hardware components, ensuring traceability from development to production. Managing change requests, conducting configuration audits, and collaborating with various teams to synchronize configuration changes will also be part of your role. To excel in this position, you should have 3-5+ years of experience as a Configuration Manager in software development, engineering, or DevOps environments. Proficiency in version control systems, CI/CD tools, and configuration management tools is essential. Strong knowledge of change control processes, attention to detail, effective communication skills, and problem-solving abilities are key requirements. Familiarity with DevOps principles will be beneficial for this role. Your contribution as a Configuration Manager will be crucial in ensuring the successful implementation of configuration management practices within our project. If you are detail-oriented, possess strong organizational and communication skills, and have a passion for maintaining configuration integrity, we would like to hear from you. Join us in our mission to streamline configuration management processes and drive project success.,

The AGM / DGM Technical Services position requires a candidate with a B.Pharma / M.Pharma qualification and 15 to 20 years of experience in tech transfer activities of solid oral dosage forms for regulated markets. The ideal candidate should have experience in managing a team of 15 to 20 scientists, documentation officers, and technicians. As an AGM / DGM Technical Services in Kandivali, Mumbai, your responsibilities will include planning and executing scale-up and Exhibit batches of solid oral dosage forms for regulated markets such as US, EU, ROW, and Canada. You will be accountable for ensuring the timely initiation of stability studies for exhibit batches and overseeing the technical service area, specifically the Pilot batch area. Your role will involve reviewing all relevant documents for scale-up and Exhibit batches execution, such as BMR, BPR, Protocols, scale-up report, exhibit batches report, and providing filing documents to RA. You will collaborate with cross-functional teams including site manufacturing team (Production, QA, QC), R&D, RA, PDC, and Supply Chain to meet aggressive timelines for regulatory submissions and business priorities. In addition, you will be responsible for reviewing, approving, and effectively implementing change control proposals, deviations/incidents, and CAPA for scale-up and exhibit batches. Addressing deficiencies identified by regulatory agencies related to drug products and supporting the production department for validation batches and troubleshooting of commercial batches will also be part of your duties. It is essential to perform all job responsibilities in compliance with cGMP, SOPs, and other regulatory agency requirements to ensure quality and regulatory standards are met.,

About Us bp Technical Solutions India (TSI) centre in Pune aims to build on bp's existing engineering and technical strengths to deliver high-quality services to its hydrocarbons and new energy businesses worldwide. TSI brings together diverse engineering capability to provide technical services across a range of areas including engineering, maintenance, optimization, data processes, projects, and subsurface, to deliver safe, affordable, and lower emission energy, while continuously innovating how we work. About The Role As a Cost Engineer, you will provide cost engineering support to the project portfolio and be responsible for cost reports, delivery, identification, and mitigation of risks related to the cost aspects of projects. What You Will Deliver - Contribute to the cost team for the standardization and digitization of cost processes. - Support team members in personal and professional development and help the team build capability. - Plan and support the team as per business requirements and manage day-to-day work completion. - Provide assurance to Project Controls Managers that project final forecast cost and value of work delivered are accurate. - Provide overall commentary and insight into operating base cost performance. - Coordinate and consolidate the overall final forecast cost to support financial reporting and provide flow to work cost engineering support to other operating bases as required. - Collaborate with procurement & finance teams to ensure roles and responsibilities are clear across the operating base. - Act as a focal point across the operating base as appropriate for ad hoc cost requests from stakeholders. What You Will Need To Be Successful - Educational qualifications: Bachelors/Masters degree in engineering, Project Management, or other relevant discipline. - Certifications: Preferred education/certifications: Project Management Certifications - PMI/PMP. - Minimum 5+ years of relevant experience and a total of 10+ years of experience. - Must-have experiences/skills include self-motivation, experience of working in large energy projects as a cost engineer, ability to interface, influence, and work effectively with members of Project Leadership, bias for simplification and efficiency, ability to build partnerships, produce high-quality reports and presentations, utilize digital tools effectively, excellent communication and language skills, and a proven track record of supporting businesses remotely for a sustained period. - Good to have experiences/skills include advanced skills in Microsoft products. Why join bp At bp, we support our people to learn and grow in a diverse and exciting environment. We believe that our team is strengthened by diversity. We are committed to fostering an inclusive environment in which everyone is respected and treated fairly. We offer benefits to enable your work to fit with your life, including flexible working options, a generous paid parental leave policy, and excellent retirement benefits, among others. Travel Requirement Up to 10% travel should be expected with this role. Relocation Assistance This role is eligible for relocation within the country. Remote Type This position is not available for remote working.,

The Quality Engineer plays a crucial role within the Quality department, serving as a functional expert for the Change Management process. This position requires in-depth knowledge of CAPA, NC, and Investigations, as well as proficiency in the change control process. One of the key responsibilities is to address and resolve issues related to Change and Documentation Modules on SmartSolve. In addition, the Quality Engineer collaborates with the Master Data Team to resolve issues in SAP for the ECO notifications. It is essential to maintain procedures for Document Control and Change Control processes while ensuring compliance with the established Change Management process. Timely review of approvals and implementation of updates is vital to support the various business units effectively. Apart from the primary skill set, the role also demands proficiency in Microsoft Office, drawing packages such as CAD, and familiarity with ERP systems, preferably SmartSolve and SAP. The ideal candidate should possess exceptional organizational skills with the ability to prioritize tasks efficiently. Strong interpersonal skills are also a key requirement for effective communication and collaboration within the team.,

The C&P Transformation Portfolio Management Office (PMO) Lead supports the Customer & Products (C&P) Leadership team in steering the delivery of business transformation towards a driven Integrated Energy Company. You will be responsible for bringing clarity and execution field to all transformation programs and cost initiatives across the C&P businesses, as well as interdependencies with planned changes in the wider organization. Working collaboratively with program PMOs, business transformation managers, and the Group Transformation office (GTO), you will build coordinated timelines, reports, and risk overviews to provide insights for progress, prioritization, risk management, and interventions across the execution of different transformation programs. Additionally, you will provide data-driven insights and challenge the delivery of the cost savings target and handle a continuous backlog of strategic cost opportunities. Key Accountabilities: - Coordinate inputs from C&P business units and Enablers into coordinated transformation plans, monthly reports, and risk register - Lead monthly reporting into GTO - Maintain up-to-date action plans and follow up on delivery - Set up program metrics and reporting in conjunction with the PPM Cost Transformation lead - Act as a central hub for standard processes and findings between program PMOs Summary Decisions: - Perform portfolio program management - Perform strategic analysis and data analysis - Perform coordinated project plan creation and management Requirements: Education - University-level degree or equivalent experience Experience - Commercial competence, program management experience on sophisticated global programs, evidence of senior customer management, deep experience of at least one C&P business Skills & Proficiencies: - Comfortable with ambiguity - Strong impact and influencing skills - Strategic insight and ability to progress complex problems in a changing environment - Excellent communication across all levels of the organization - Strong English knowledge in written and spoken form - Strong self-organizing and well-structured working attitude - Strong capability in digital tools (MS Outlook, Excel, Word, PowerPoint) - Strong project management skills - Good financial skills - Ability to understand changes in external and internal business environment - Strong in dealing with organizational change Value & Behaviours: - Build positive relationships based on trust and honest discussions - Listen carefully and consider different perspectives - Pursue detailed management through standardization, clarification, and the elimination of defects - Follow and uphold the rules and standards of BP and hold others accountable for the same - Always strive to do the right thing based on BP's rules and standards - Speak out when you see something is not right and be prepared to say no or stop when vital Travel Requirement: Up to 10% travel may be expected with this role Relocation Assistance: This role is eligible for relocation within the country Remote Type: This position is not available for remote working Legal Disclaimer: Employment may be contingent upon adherence to local policy, including pre-placement drug screening, medical review of physical fitness, and background checks.,

13-15 years of experience with QMS Activity and all QA activities. Process validation cleaning validation Monitoring of IPQA Data Integrity