POSITION SUMMARY The Process Compliance Sr. Officer, Manufacturing ensures compliance with cGMP GSP and sustainability of checks and controls at contract manufacturing sites. This role includes training CM staff, managing investigations, and providing routine status updates. Sr. Officer, Process Compliance - Manufacturing Ensure cGMP and GSP compliance at CM sites. Monitor shop floor activities, including GMP rounds and verification of manufacturing and packaging processes. Support CMs with troubleshooting and document batch processes. Manage and review investigations to identify root causes and implement effective CAPA. Track open investigations and ensure timely closure. Compile daily observations and provide routine updates on manufacturing investigations. Drive visual management to track progress and meet timelines. Organize cross-functional resources for investigations and delegate responsibilities. Support OpEx team with training and verification of action items. MINIMUM QUALIFICATIONS Education : Graduate in Food Technology, M.Pharmacy, Nutrition Science, or Mechanical with Food industry experience. Skills : Result-oriented and team player. Leadership skills for shop floor teams. Proficient in Microsoft Office (Word, PowerPoint, Excel). Good communication skills, both written and verbal. Experience : 3-5 years in Pharma/Nutraceutical/Food industry. Experience in QA/Manufacturing functions.

Key Responsibilities: Execute routine downstream operations including chromatography (affinity, ion exchange, HIC), filtration techniques (TFF, UF, DF, NF), buffer preparation, and formulation of mammalian cell culture-derived products. Maintain accurate documentation including batch records, deviation reports, SOPs & other QMS elements. Support scale-up and tech transfer from lab to pilot/production scale. Ensure strict compliance with cGMP and safety protocols. Collaborate with QA/QC, maintenance, and engineering teams for smooth operations. Troubleshoot process deviations and contribute to root cause analysis and CAPA implementation.

Job Purpose: The QA Auditor is responsible for evaluating and ensuring compliance with applicable regulatory standards, including Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP), across clinical research and laboratory operations. This role supports the organization's commitment to quality and regulatory integrity by conducting internal and external audits, identifying non-compliance, and driving corrective and preventive actions. The QA Auditor plays a critical role in maintaining high standards of data integrity, patient safety, and regulatory compliance, while supporting continuous quality improvement in alignment with international guidelines and sponsor expectations. Role & responsibilities: 1. Planning, Execution, and Oversight QA review of protocols, study/validation plan, and amendments, if any. Audit Planning and Management To plan & conduct in-process audit of studies and method validation to assure compliance with WHO-GCLP & applicable principles of GLP and ICH-GCP, SOPs, protocol, study plan/validation plan, STP, and applicable regulatory guidelines. Conduct retrospective audit of study raw data & report and validation raw data & report to assure compliance with WHO-GCLP and applicable principles of GLP & ICH-GCP, SOPs, protocol, study/validation plan & applicable regulatory guidelines, and prepare QA statement/authentication. To conduct system audit of various departments as per pre-defined schedule to assure compliance as per in-house SOPs and prepare & communicate audit report. Vendor audits/supplier audits. To review the Analytical and functional characterization data 2. Oversight of QMS Review of SOPs Monitoring and review of deviations Monitoring and review of change controls Monitoring corrective and preventive action 3. Assist in Sponsor Audits/Client & Regulatory Inspections To assist Lead, QA/designee to host sponsor/client audits and regulatory inspections. To assist Lead, QA/designee to address sponsor/client audit response as well as its closure (as applicable). To assist Lead, QA/designee to review regulatory audit response and queries as well as its closure (as applicable). To assist Lead, QA/designee to track, prepare and submit regulatory applications and follow-up until its approval. 4. Review & Monitoring To prepare and review quality assurance SOPs and review applicable operational SOPs. To review and provide inputs on audit reports prepared by QA team for delegated audits. To ensure closure of all raised observations and provide QA authentication. To ensure the controlling and distribution and QA data archiving. To ensure the controlling and distribution of documents. To update quality manual & its annexure periodically To assist Lead, QA/designee for trend analysis and quality review meetings. 5. Training & Development To train the new joiner in QA department on various QA aspects as well study/validation aspects as applicable. Maintain quality culture within department. 6. Other Responsibilities Any other responsibilities assigned by head, quality assurance/designee

Well known Denmark based pharma co Hiring QA Pharmacist Excellent communication skills 5 days working Pl share updated CV to careers5.righthire@gmail.com

The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Sr Associate include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a type of person with these qualifications. Basic Qualifications: Master’s degree OR Bachelor’s degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Associate’s degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Diploma and 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Degree in Life Science discipline Regulatory CMC specific knowledge & experience Understanding and application of principles, concepts, theories and standards of scientific/technical field Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry

About Amgen Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Sr Validation Engineer What you will do Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen’s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients. The Senior Validation Engineer will oversee strategies and documents related to DS/DP Process Performance Qualification, Cleaning Validation, and Packaging Qualification at contract manufacturing organizations (CMOs) located across North America, Europe and JAPAC regions. The candidate should have prior experience with qualification of the following modalities, primarilysynthetic API/DS and DP manufacturing, FDP and packaging qualification, and aseptic DP. Be an integral quality member of Amgen cross-functional contract manufacturing teams that includes but is not limited to operations, analytical science, process development, supply chain, etc. Project teams will includetech transfers, new product introductions, and ongoing validation maintenance activities. Roles & Responsibilities: Translate Amgen requirements into the language of the CMO Identify and assess validation/quality risks to enable risk-based decisions Validation document author/approver Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes. Aseptic processing system oversight (media fill, autoclave validation, EM) Prepare materials/documents (playbooks) for topics to be presented during audits/inspections Perform validation change control assessments Review/approve validation deviations Review/approve Master Batch Records Perform Person in Plant activities as required Escalate issues to Validation/Quality management, as needed Author Validation sections of Marketing Applications Write/review responses to regulatory questions (RTQs) Drive Operational Excellence and Champion Change Authority: Determine outcome of validation activities Decision to approve or reject validation documentation Provide input on Validation position on related topics and strategy for the site Decision to approve Master batch Records This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you Basic Qualifications and Experience: Doctorate degree OR Master’s degree with 4 to 6 years of experience in process validation or a related field OR Bachelor’s degree with 6 to 8 years of experience in process validation or a related field OR Diploma with 10 to 12 years of experience in process validation or a related field. Functional Skills: Must-Have Skills: Prior experience serving as Validation lead for NPI or tech transfer of manufacturing processes. Relevant experience in qualification of finished drug product and packaging processes. Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them Good-to-Have Skills: Working foundation in cleaning validation and aseptic process simulation.Experience in resolving complex deviations associated with validation studies. Understanding of the applicable manufacturing/testing processes (i.e. Synthetic API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Proven experience in designing and/or improving processes at conceptual level Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations that comprise a robust Validation package. 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 for a career that defies imagination Objects in your future are closer than they appear. Join us. 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.

What you will do Let’s do this. Let’s change the world. In this vital role you will conduct complex complaint investigations, resolves corrective actions with their effectiveness and resolves steps necessary to ensure the proper level of control for product in distribution. We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. Ensures quality of complaint records Applies analytical abilities to evaluate complex situations using multiple sources of information Execution of regulatory and SOP requirements Anticipates and prevents potential issues with regulators Provides guidance and technical advice Evaluates subject matter expert assessments Raises potential Quality issues to Management What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR , Master’s degree and 4 to 6 years of Specialist Quality Complaints experience OR , Bachelor’s degree and 6 to 8 years of Specialist Quality Complaints experience OR , Diploma and 10 to 12 years of Specialist Quality Complaints experience Preferred Qualifications: Quality and manufacturing experience in biotech or pharmaceutical industry Ability to oversee multiple projects simultaneously Ability to successfully handle workload to timelines Familiarity with basic project management tools Ability to negotiate a position after taking feedback from multiple sources Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) 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 for a career that defies imagination Objects in your future are closer than they appear. Join us. 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.

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs tasks of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Veeva Regulatory Suite experienceCollect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Life Sciences Regulatory ServicesAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamLife Sciences Automation Enablement Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

Job Overview: As a Peptides Production Executive, you will be responsible for learning and assisting in the production of peptides according to established protocols and quality standards. This position is designed to provide hands-on training in peptide synthesis, purification, and related processes. Key Responsibilities: Understand and follow standard operating procedures (SOPs) for peptide synthesis. Assist in the preparation of reagents, solutions, and equipment for peptide production. Execute peptide synthesis under the guidance of experienced personnel Learn and perform purification techniques such as HPLC, chromatography, and filtration. Assist in maintaining accurate records of production and testing activities. Follow Good Manufacturing Practices (GMP) and safety guidelines. Learn to operate and maintain peptide production equipment. Report equipment malfunctions or abnormalities promptly. Maintain accurate and detailed records of all production activities. Compile data and assist in preparing production reports. Communicate effectively with team members and supervisors. Contribute to the identification and implementation of process improvements. Provide feedback on procedures to enhance efficiency and quality Attend training sessions to enhance knowledge and skills. Actively participate in professional development opportunities. Preferred candidate profile: Basic understanding of peptide synthesis principles is a plus. Strong attention to detail and commitment to quality. Ability to work in a team-oriented environment. Good communication and interpersonal skills. Willingness to learn and adapt to new processes. Experience: Minimum 2 yrs in peptides manufacturing Masters/Bachelors degree in Chemistry or a related field.

Job Responsibility: Manage the following tasks: Prepare and manage all the meetings and documents related to the project (agenda, minutes, Team Site, TC .) Ability to develop solution by creating mockups in the laboratory. Create commissioning protocoled in order to perform testing to confirm the design in regard to early requirements Act as a validation expert on SUS by: Creating Design Summary Reports (DSR) based on the feedback of the users Conducting Failure Mode and Effect Analysis (FMEA) by organizing workshop with the different users in order to capture and evaluate the risks linked to the items to be validated and the usage in the production(s) area. Update the FMEA to V2 at the end of the qualification Based on the UR Tool and the FMEA Developing the User Requirement Specifications (URS) Create, Coordinating and manage the electronic Change Control (eCC) Based on the URS and the documentation received by the supplier, executing Design Qualification (DQ). According to the requirements that are still not met during the DQ, develop a Validation Master Plans (VMP) in order to meet all the requirements of the URS. According to the validation strategy developed in the VMP, write the IOQ protocole, conduct the test in the laboratory with the protocol and finalise the report based on the testing in the laboratory. Ability to manage incidents that may occur during the laboratory testing. Compiling and summarize the validation evidence in the Validation Summary Reports (VSR) Conducting Chemical Compatibility Risk Assessments (CRA) based on data from the supplier Performing Leachable Risk Assessments (LRA) covering extractible approaches Calculate Patient Exposure Scenarios (PES) based on the raw data from the supplier Conducting risk assessments and writing technical rationales. Ability to conduct BCT testing for shipping validation (in coordination with external lab) Manage the PO process, acquiring components from manufacturers. Ensure progress of the project in alignment with the implementation/PPQ timeline Anticipate RA impacts and documentation needs with the regulatory Shipping of components from manufacturers to external laboratories, ensuring full GMP traceability, and completing the necessary GMP sending checklist. Provide weekly reporting on progress status, performances and issues to VTT manager Create and manage the appropriate master data linked to the creation of the new items. Ability to interact and manage suppliers in the frame of tenders for new business allocation. Skillsets Required: Advanced degree in chemistry, biology, chemical engineering or similar field of study. Experience: at least 1-5 years of experience in pharmaceutical or biopharmaceutical MSAT or a related field. A scientific and technological know-how related to Single Use validation and vaccines manufacturing is an additional asset. Project management skills and Validation technical skills Knowledge and understanding of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). Hands on mentality/approach and ability to work in the laboratory. Good knowledge of GSK organization and GSK governance Flexibility to face rapidly changing environment Ability to work in a matrix international organization. Proficiency in writing DSR, FMEA, URS, DQ, VMP, IOQ, VSR, Commissioning protocole, extractable protocols, biocompatibility reports, and leachable risk assessments and PES calculation. Skills to report GSK internally but also with partners externally. Social skills to foster teamwork of people belonging to different organizations / departments / sites/external partners. Excellent communication and negotiation skills. Written and oral fluency in English. Scope: MSAT, or Manufacturing Science and Technology, is a critical function within a pharmaceutical and biopharmaceutical manufacturing organization in general. The GSK MSAT team is responsible for ensuring that products are produced safely, efficiently, and to the highest quality standards. Here are some key activities carried out by the MSAT team: o Process Optimization and Troubleshooting. o Technology Transfer. o Process Validation. o Continuous Improvement. o Technical Support. o Regulatory Compliance. o Data Analysis and Reporting. o Training and Development.

Preparation of APQR, review of documents and records. Supporting to Customer complaint & assistance in implementation of CAPA. To assist in maintaining Food safety & Quality management system. To review HACCP verification & validation plan, adhere to FSSAI requirements for the food premixes division and comply with the requirements of various regulatory authorities and customers. To review SOPs, batch manufacturing and packing records, specifications and test methods of the products. Handling of deviations, change controls, out of specifications may occur at all stages of storage, dispensing, manufacturing, packing, testing and distribution. To ensure issuance, control, distribution, storage, retention and destruction of quality documents and corporate guidelines as per Food safety & Quality management system. To assist in compliance to the current ISO 9001, D&C Act, FSS Act 2006, FSSC 22000, FAMI-QS, WHO-GMP, UNICEF and other customer and regulatory requirements. Reporting of daily non-conformance, online deviation if any. Preparation and updation of Q.A departmental SOP s and loading it in DCS (Document Control System) ENSUR, Change control in trackwise and handling of SAP system. To assist in an audit and compliance process. To provide necessary documents required by CQA and other customers. Co-ordination with marketing Representative in responding customer queries and submitting Questionnaire as per customer requirement. Execution of requirements for food/Dietary supplements regulations for export market (US)-21 CFR Part 111. Ensuring avoidance of breach of data integrity in area. Imparting necessary assistance to shop floor personnel. Adherence to the requirements of EHS norms. Execution of various initiatives as are suggested by corporate functions (SEEDS, Learning University, Quality mindset). Customer / Patient centricity. Document Archival. To assist in effective Hygiene and sanitation program in area. Execution of various initiatives as are suggested by corporate functions. To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same. To implement QEHS policy & objectives. To ensure participation and consultation of worker. Ensure use of PPE To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same. To ensure work permit system during maintenance activities. To implement QEHS continual improvement projects at site and monitor. To ensure disposal of waste. Authorized to prevent improper workplace conditions. Authorized for reporting of Hazards, Incident, Accidents and Near miss reporting. Authorized to prepare OH&S performance document. Authorized to conduct training of workmen related to OHSMS. Insuring shade cards and artwork Preparation and review of quality risk assessments MSC / B. Tech food Technology

Responsible for handling of day-to-day Instrumentation activities in unit-III blocks. Responsible for timely closure of work orders & attend shift works with priority. Responsible for maintenance, calibration & troubleshooting of FCV, Flow meters, PRV, BPRV, on off Valves, DCS, Instruments trouble shooting, data loggers, Hygrometers, weighing balance, weighing scales and legal metrology compliances etc. Responsible for calibration schedule monitoring & calibrations of Instruments as per schedule. Responsible for document preparation, records maintenance, logbook recording as per Good Documentation Practices (GDP). Responsible for reviewing the external agency calibration certificates. Responsible for provide biometric access to authorized persons into restricted areas. Responsible for verification of Time synchronization in biometric access system & Digital clocks. Responsible for interlocks verification in DCS. Responsible for Testing of Hooter as per schedule. Responsible for Battery replacement of wireless data loggers as per schedule. Responsible to prepare qualification documents for new systems along with users. Responsible for activities to be carried out in compliance with GMP & Data integrity. Responsible to keep instrumentation department/documents ready for audits. Responsible to comply all statutory and EHS requirements. Responsible to follow work procedures & work permit systems during work execution. Responsible to support investigations for deviations, incidents, accident, near miss etc. Responsible for the work of senior in the absence of senior. Responsible for spares management, Intimation of Instrumentation items stock level to superiors for procurement. Responsible to support during Projects activities or modification activities in plants. Responsible for PM activities of equipments and DCS systems. Diploma In Electrical / Eectronics / B.Tech in EEE

Responsible & Accountable for smooth & timely dispensing of Raw Materials for Liquid, N-Block and Vitamin Mineral Premix products. Partially responsible & Accountable for compliance with Rules & regulations of Goods & Service Act. Partially responsible & Accountable for compliance with Legal Metrology (Weights & Measures) Act Ensuring avoidance of breach of data integrity at all the levels. To follow effective sanitation activities at all the levels. To align for Patient Centricity and Customer centricity. To follow Food safety, Quality, Environment and Occupational Health & Safety management system at warehouse activities of General Tablet Plant and to identify areas for improvement. To ensure compliance to the regulatory, customer, legal requirements and face audits. Also to comply non-conformities observed during the audits. To ensure compliance to the current ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, D&C Act, FSS Act 2006, FSSC 22000, Kosher, Halal, RSPO, FAMI QS, WHO-GMP, UNICEF, WFP GAIN and other customer and regulatory requirements. To ensure compliance to the audit observations of warehouse activities of Main Plant. To follow requirements of food regulations for export market (US)-21 CFR Part 110 & 111. Imparting required training to shop floor personnel. Adherence to the requirements of EHS norms. To follow various initiatives as are suggested by corporate functions (Piramal Learning University & Quality mindset). To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same. To implement QEHS policy & objectives. To ensure participation and consultation of worker. Ensure use of PPE To identify & communicate incidents, QEHS non-conformities, investigate and take corrective actions on the same. To ensure work permit system during maintenance activities. To implement QEHS continual improvement projects at site and monitor. To ensure disposal of write-off material. Authorized to prevent improper workplace conditions. Authorized for reporting of Hazards, Incident, accidents and near miss Reporting. Authorized to prepare OH&S performance document. Authorized to conduct training of workmen related to OHSMS. Bachelor of Science.

" Jubilant Life Sciences Limited is one of the Indias leading corporate and a highly treasured brand throughout the world. The organization has a presence in the fields of Pharma and Life Sciences, Agri & Performance Polymers, Food & Retail, Oil & Gas and Services. Jubilant Life Sciences Limited is an integrated global pharmaceutical and life sciences Company engaged in Pharmaceuticals, Life Science Ingredients and Other businesses including Drug Discovery Solutions and India Branded Pharmaceuticals. The Pharmaceuticals segment, through its wholly owned subsidiary Jubilant Pharma Limited, is engaged in manufacturing and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile Injectable and Non-sterile products through 6 USFDA approved manufacturing facilities in the US, Canada and India and a network of over 50 radio-pharmacies in the US. The Life Science Ingredients segment, is engaged in Specialty Intermediates, Nutritional Products and Life Science Chemicals through 5 manufacturing facilities in India. The Drug Discovery Solutions business, provides proprietary in-house innovation & collaborative research and partnership for out-licensing through 2 world class research centers in India. Jubilant Life Sciences Limited has a team of around 7,700 multicultural people across the globe and is committed to deliver value to its customers across over 100 countries. The Company is well recognized as a Partner of Choice by leading pharmaceuticals and life sciences companies globally. Ranked No. 6 amongst top 10 Global Pharmaceutical outsourcing players as per UNCTAD World Investment Report 2011 Reputed and High Quality relationships with 19 out of the top 20 Pharmaceutical companies, and 6 out of the top 10 Agrochemical companies globally Vision To acquire and maintain global leadership position in chosen areas of businesses To continuously create new opportunities for growth in our strategic businesses To be among the top 10 most admired companies to work for To continuously achieve a return on invested capital of at least 10 points higher than the cost of capital. Our Promise We will, with utmost care for the environment and society, continue to enhance value for our customer by providing innovative products and economically efficient solutions; and for our stakeholders through growth, cost effectiveness and wise investment of resources. Kindly refer www.jubl.com for more information about organization. Position Executive / Sr. Executive- QC Grade : A3 A4 Business Unit / Function Department Quality Control Location Bharuch SEZ Reports to Lab In charge-QC Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation & compliances of ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP, USFDA, FSSC -22000, NABL Analytical skill for QC instrument, i.e. GC-HS, UPLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Regularize the QC activities as per cGMP requirements. RM, PKG, In-process and FG sampling & Analysis. Co-ordination with QC staff, R&D, Commercial and production for quality & dispatch related activities for on time dispatches. Day to day monitoring and execution online all IPQC and FG analysis activities. Resolve the trouble shooting related to QC instruments & activities. Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11), 217 Awareness about responsible care (Environment, Health, Safety and Security) Documentation work SOP Preparation, MOA Preparation, Investigation. No. of Reportees Qualification & Experience M.Sc. (Chemistry) with 2 - 6 yrs. Key Competencies (Technical, Functional & Behavioral) Handling, Calibration and Hand-on experience of all QC instruments. Compliance of 21 CFR Part-11. Troubleshooting related to QC analytical instrument ",

Responsible & Accountable for smooth & timely dispensing of Raw Materials for Liquid, N-Block and Vitamin Mineral Premix products. Partially responsible & Accountable for compliance with Rules & regulations of Goods & Service Act. Partially responsible & Accountable for compliance with Legal Metrology (Weights & Measures) Act Ensuring avoidance of breach of data integrity at all the levels. To follow effective sanitation activities at all the levels. To align for Patient Centricity and Customer centricity. To follow Food safety, Quality, Environment and Occupational Health & Safety management system at warehouse activities of General Tablet Plant and to identify areas for improvement. To ensure compliance to the regulatory, customer, legal requirements and face audits. Also to comply non-conformities observed during the audits. To ensure compliance to the current ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, D&C Act, FSS Act 2006, FSSC 22000, Kosher, Halal, RSPO, FAMI QS, WHO-GMP, UNICEF, WFP GAIN and other customer and regulatory requirements. To ensure compliance to the audit observations of warehouse activities of Main Plant. To follow requirements of food regulations for export market (US)-21 CFR Part 110 & 111. Imparting required training to shop floor personnel. Adherence to the requirements of EHS norms. To follow various initiatives as are suggested by corporate functions (Piramal Learning University & Quality mindset). To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same. To implement QEHS policy & objectives. To ensure participation and consultation of worker. Ensure use of PPE To identify & communicate incidents, QEHS non-conformities, investigate and take corrective actions on the same. To ensure work permit system during maintenance activities. To implement QEHS continual improvement projects at site and monitor. To ensure disposal of write-off material. Authorized to prevent improper workplace conditions. Authorized for reporting of Hazards, Incident, accidents and near miss Reporting. Authorized to prepare OH&S performance document. Authorized to conduct training of workmen related to OHSMS. Bachelor of Science.

Key Roles & Responsibilities: 1. Oversee and support the overall activities during the product development life cycle from quality perspective in R&D (API and intermediates). 2. To understand the site needs with respect to system establishment and sustainability. 3. Author/ Review and approve the SOPs/work directions required for implementing the Quality systems in R&D activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions. 4. Review and approve Lab Familiarization Reports (LFR), Product development reports (PDR), Technology transfer, product specifications & STPs, analytical method validation, method transfer, qualification, calibration, process validation protocol and reports. Ensure effective execution of these activities. 5. Periodic audits of R&D laboratory. Ensure online documentation and review lab notebooks, PDR/LFR documents, analytical documents and stability data. 6. Effective maintenance of R&D records, distribution and archival systems. 7. Perform cGMP audit of R&D facilities and operations. Assist the team in auditing contract manufacturers/ vendors/ contract testing laboratory. 8. Ensure R&D team is trained for their relevant job function and GMP/ GLP training. 9. Provide quality related inputs to new projects, existing project, up gradations etc. 10. Participate in identification of key starting material (KSM)/ registered starting material (RSM) and ensure that it is correctly identified. 11. Participate in handling of OOS, OOT, Deviations, Batch failures, investigations and CAPA implementation at site. 12. Establish raw material standards by studying manufacturing/ R&D requirements-conferring with suppliers. 13. Responsible to follow the safety and environmental procedures deployed in the site. Graduation and above in Science / Pharmacy

Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla Travel: Low Job Overview Responsible for all artworks and labeling components of Piramal Critical Care Products Worldwide with adherence to the labeling processes, ensuring compliance with innovator labeling, internal & external partners, and GMP standards and specifications. Participate in a cross-functional team environment as necessary to ensure labeling documents and associated change requests are medically and scientifically accurate and that they comply with regulatory standards, meet company needs and accurately assess current strategy and global regulations Key Stakeholders: Internal Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Leadership team Key Stakeholders: External Country Distributors, Health Authority (HA), CMOs and external partners Reporting Structure Reports to: Manager - Labelling ESSENTIAL QUALIFICATION: Bachelor degree or Master s degree in Pharmaceutical sciences or equivalent Experience 4 years relevant regulatory experience (Global experience including US, EU and major Rest of World markets preferred) Roles and Responsibilities: Global labeling details (labels, cartons, package inserts, patient package inserts) to ensure quality and accurate compliance, evaluations, maintenance, reviews and approvals with cross-functional teams for regulatory submissions Preparation of Labelling related documents ex: SmPC, PIL and Labelling texts for submission in EU region. Coordinating with the different stakeholders for timely labeling related submission/approval and query solving. Proofreading all types of label copy/annotation/etc. at all developmental stages as well as final label copy to ensure accuracy of labeling Creation of SPL for US Human and Vet product submissions, drug listing, annual establishment registration and annual self-identification for GDUFA Monitor and process innovator-labeling updates for existing generic products and ensure compliance with innovator updates, including side-by-side comparison with RLDs Responsible for coordination of CCDS development and updates of PCC products and coordination of local labeling updates Contribute to the development and/or review of all labeling aspects included in Promotional Material. Development and maintenance of a central repository for all labeling components Competencies Must have solid interpersonal and organization skills for interfacing with others. Knowledge of Health Authority labeling regulations and requirements. Self-directed, motivated, organized, flexible and accountable. Excellent work ethic with a positive, can-do attitude to succeed in a fast-paced environment. Project management skills is a plus

Job Summary : Experienced QC professional with 8-10 years in pharmaceutical quality control and compliance. Responsible for preparing specifications, test methods, and maintaining GMP, GDP, and GLP standards. Supports regulatory affairs, handles deviations, OOS, and change controls, and reviews analytical reports. Proficient in SOP creation, method updates, and team training as per cGxP and regulatory guidelines. Responsibilities: Preparation and updating specifications and test methods to ensure compliance with statutory and company standards Preparation of specification for input materials, intermediates, active pharmaceutical ingredients, finished products and stability products to ensure compliance with company standards. Maintenance of GMP, GDP & GLP in work To maintain Quality Control documents as per statutory requirements Updation and analysis of methods and analysis as per current cGCPL guidelines and regulatory requirements. Support to Regulatory affairs departments, as required Adherence to cGMP, ISO 14001, FSSC 2200 and HACCP norms and guidelines as required Preparation of SOP and related documents Initiating and involving in the incident, deviation and OOS. Initiating change control and edit form to make any changes required in the specifications, standard testing procedures, raw data sheets and SOP and closing the same Review and approval of analytical reports as required Training of concern persons related to quality documents as required Education Qualification: MSc Chemistry Years of Experience : 8 to 10 Years

At Smith+Nephew , we design and manufacture technology that takes the limits off living! The IT Business Analyst for Regulatory Affairs will collaborate with business leaders and product owners to define, justify, and deliver IT solutions that meet business objectives, create competitive advantage, and leverage internal and external IT resources. Responsibilities include contributing to strategy, gathering requirements, advising on industry trends, building capability roadmaps for short- and long-term needs, and analyzing processes for improvement and cost-benefit. What will you be doing? Provides Business Analysis and Requirements management in support of Regulatory Affairs group Elicit, define, analyze, and document testable business requirements, collaborating closely with customers, end users, and the IT team. Leverage good communication and analytical skills, business relationships, and business process expertise to understand, document, assess, and drive business change needs to accelerate process improvement and business growth. Drives re-use of existing solution capability or introduction of new technology to achieve program or project objectives Works independently and simultaneously on multiple projects with various domain experts to understand current business process landscape, enterprise alignment, and growth. Business Analysis ownership for [functional processes], Identify and evaluate potential solutions, favouring existing invest application estate. Prepares cases which define potential benefits, options for achieving these benefits through development of new or changed processes, and associated business risks. Measurably improve business process capability and performance indicators for delivered projects Attain a high re-use of technology while driving process standardization for owned processes Drives effective requirements' definition that creates objective, testable requirements that results in a business solution which meets or exceeds the defined objectives. Create functional requirements in Use Cases. Coordinate requirements walk-through and signoffs, verifying with collaborators that Use Cases and process models accurately portray specific business needs. Recommends options that best fit the business needs, value proposition and strategic roadmap. Identifies, analyses, and fixes the root cause of business and technical issues. What will you need to be successful? Education: Bachelors or masters degree in computer science, information systems, business administration, or other related field, or equivalent work experience. Experience : Minimum 5-7 years of relevant technical or business work experience . With at least 3 years of experience in information technology & regulatory affairs . Certification in business analysis is preferred. Proven Experience with Rimsys and PTC Windchill (PLM systems) Solid experience working within GxP-regulated environments , including validation of systems, Quality Systems, and compliance with regulatory standards Business process design and reengineering techniques and methods. Business analysis: takes responsibility for investigative work to determine business requirements and specify effective business processes through improvements in information systems, information management, practices, procedures, and organizational change. Selects and embraces suitable business analysis methods, tools, and techniques, selecting the appropriate approach from predictive (plan driven) or adaptive methods (iterative/agile). Collaborates with partners at all levels in the conduct of investigations for strategy studies, business requirements specifications, and feasibility studies. Designs and manages tests of new/updated processes. Manages selection/creation of relevant scenarios for testing and ensures that tests reflect realistic operational business conditions. Ensure tests and results are documented, reported to partners, and are available for specification of user instructions. Highlights issues and risks identified during testing to business customers. Defines and manages prioritizing, requirements definition, and prioritization activities for initiatives of medium size and complexity. Facilitates input from customers, provides constructive challenge, and enables effective prioritization of requirements. You Unlimited. We believe in crafting the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/). Other reasons why you will love it here! Your Future: Major medical coverage + policy exclusions and insurance non-medical limit. Educational Assistance. Work/Life Balance: Flexible Personal/Vacation Time Off, Privilege Leave, Floater Leave. Your Wellbeing: Parents/Parents in Laws Insurance (Employer Contribution of 8,000/- annually), Employee Assistance Program, Parental Leave. Flexibility : Hybrid Work Model (For most professional roles) Training: Hands-On, Team-Customized, Mentorship Extra Perks: Free Cab Transport Facility for all employees; One-Time Meal provided to all employees as per shift. Night shift allowances.

Role & responsibilities Excels in managing the quality inspection & release programs for company's Pharma products and leading validation, qualification, QA, analysis & sampling of Raw Materials (API & Formulation) and Packaging Material. Expertise in driving QMS/QC Activities - OOS, Deviation, Change Control, Risk Assessment, Investigations, RCA, CAPA, Audits, Equipment Calibration & Validation on the shop floor for ensuring adherence to GMP and Regulatory Compliance.

Summary Provide regulatory CMC operational, submission and compliance support to department in accordance to defined requirements to guarantee timely preparation of high-quality CMC regulatory submissions and associated compliance information throughout the life cycle. About the Role Major accountabilities: Perform compliance and operational activities including QC check, DA checks and IND annual report writing. CMC contact for some countries and compliance/ regulatory database entry and reports Create CMC submission documentation such as folders structure, metadata forms, RA request forms and act as data stewards in the applicable Regulatory Information Management System Ensure CMC documentation is eCTD compliant, eCTD filenames assigned, Document formatting (DA) checked, PDF properties are compliant for eCTD submission, documentation is finalized and eCTD file names assigned Coordinate data/KPIs required for reports within RA CMC Support project teams for document finalization, collate ancillary documents requirements from various sources (e. g. databases, OneNote, trending etc. ) and support coordination and management through the appropriate system Coordinate, prepare and track CMC submissions for delivery to RA Operations Perform super-user role of RA CMC documentation system/ support super-user for e. g. account requests/ modifications as assigned Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System Support other GSOC team members for end-to-end submission coordination Key performance indicators: High quality regulatory submissions and operational documentation Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate CMC documentation and compliance support on matters within RA CMC control Timely and accurate information / communication about operational and compliance issues within own department and to key stakeholders Ensure that the operational activities and CMC regulatory documentation follow Novartis and eCTD guidelines. Regulatory compliance met in all compliance systems Build and maintain collaborative partnerships with stakeholder Partner with other GSOC team members to ensure business continuity Minimum Requirements: Work Experience: If University entrance or completed vocational training: Preferably 2 years in regulatory and/or experience in the pharmaceutical industry If Science Degree: Preferably 1 year in regulatory and/or experience in the pharmaceutical industry Working experience in pharma industry data systems and data management Ability to work successfully with global project teams and prioritize activities considering timelines and workload Effective planning, organizational and interpersonal skills Prior publishing experience desired Computer literacy/IT systems literacy: Excellent data processing skills Skills: Being Resilient Digital & Technology Savvy Continuous Learning Interpersonal Savvy Operational Excellence Project Excellence Education: Minimum: General qualification for university entrance or completed vocational training Desirable: Science Degree (e. g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Languages: Fluent English required (oral and written). Good written/spoken communication skills Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Summary Perform and document scientific experiments in the laboratory for drug substances (DS) and drug products (DP) in collaboration with multifunctional project teams. Contribute to maintenance of lab instruments/day-to-day operations. Timely execution of project related activities to support TRD-NCE strategies and goals. About the Role Major accountabilities: Plan, organize, execute, and document scientific experiments (e. g. , analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc. ) according to the agreed timelines and appropriate quality standards. Accountable for documentation and submission of raw data in appropriate data system (for e. g. , LIMS test activation and results entry). Responsible for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities. Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed. Responsible for assigned laboratory related area/activities (e. g. , chemical / reagents / consumables / samples / column / glassware management etc. ). Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory. Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s). Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities. Support internal and external audits and ensure no critical findings within the assigned scope. Actively contribute to team and organization goals. Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & Novartis Guidelines. Additional specific roles/tasks: See Up4Growth training assignments for the business roles for the associate as per the team matrix and completion of trainings in transcript of learning system (e. g. , Up4Growth). Minimum Requirements: Masters in Life Science (e. g. , analytical / organic chemistry /pharmacy / pharmaceutical development) or equivalent. 5+ years of relevant work experience in OSD forms- hands on in chromatography, multimedia dissolutions, In-vivo & Invitro dissolutions, quality investigations, QBD etc. Fluent in English (oral and written). Knowledge of site language, if required. Knowledge in quality principles driving drug development such as GMP. Understanding of general regulatory and quality expectations. Good scientific background, communication skills including presentation and scientific/technical writing. Work Experience: Functional Breadth. Operations Management and Execution. Collaborating across boundaries. Skills: Environment. Experiments Design. Health And Safety (EHS). Laboratory Equipment. Manufacturing Process. Materials Science. Process Simulation. Project Management. Sop (Standard Operating Procedure). Technical Writing. Languages : English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Protectron Electromech Pvt. Ltd. is looking for Quality Executive to join our dynamic team and embark on a rewarding career journey. Understand customer needs and requirements to develop effective quality control processes Devise and review specifications for products or processes Set requirements for raw material or intermediate products for suppliers and monitor their compliance Ensure adherence to health and safety guidelines as well as legal obligations Supervise inspectors, technicians and other staff and provide guidance and feedback Oversee all product development procedures to identify deviations from quality standards Inspect final output and compare properties to requirements Approve the right products or reject defectives Keep accurate documentation and perform statistical analysis Solicit feedback from customers to assess whether their requirements are met Submit detailed reports to appropriate executives Be on the lookout for opportunities for improvement and develop new efficient procedures

IVL India Environmental RD is looking for Quality Expert to join our dynamic team and embark on a rewarding career journey. Develop and implement quality assurance policies and procedures. Conduct quality audits and inspections. Analyze data to identify areas for improvement. Provide training on quality standards and processes. Ensure compliance with regulatory requirements.

IVL India Environmental RD is looking for CAD Operators to join our dynamic team and embark on a rewarding career journey. Operators play a vital role in ensuring the smooth operation of various systems and processes within an organization They are responsible for monitoring equipment, performing routine maintenance tasks, and responding to any issues that may arise during operations Here's a detailed breakdown of their responsibilities:Key Responsibilities:Monitor Equipment: Operators are responsible for monitoring various types of equipment, such as machinery, production lines, or computer systems, to ensure they are functioning properly Perform Routine Maintenance: Operators perform routine maintenance tasks on equipment to ensure optimal performance and prevent breakdowns This may include cleaning, lubricating, and adjusting machinery as needed Troubleshoot Issues: When equipment malfunctions or operational issues arise, Operators are responsible for troubleshooting the problem to identify the root cause and implement solutions to resolve it promptly Ensure Safety: Operators adhere to safety protocols and procedures to maintain a safe working environment They may conduct safety inspections, implement safety measures, and respond to any safety concerns or incidents Maintain Records: Operators maintain accurate records of equipment performance, maintenance activities, and any issues encountered during operations This documentation is essential for tracking maintenance schedules and identifying trends or recurring issues Coordinate with Team Members: Operators collaborate with other team members, such as maintenance technicians, supervisors, and quality control personnel, to coordinate activities and address operational needs effectively Follow Standard Operating Procedures (SOPs): Operators follow established standard operating procedures (SOPs) and guidelines to ensure consistency and compliance with industry regulations and quality standards Continuous Improvement: Operators actively participate in process improvement initiatives by providing feedback, suggesting improvements, and implementing best practices to enhance operational efficiency and effectiveness