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0.0 - 1.0 years
1 - 1 Lacs
Nagpur
Work from Office
The Junior Executive – Warehouse will support day-to-day operations within the warehouse to ensure the proper handling, storage, and dispatch of pharmaceutical products in compliance with regulatory and company standards. The role involves inventory
Posted 2 months ago
9.0 - 14.0 years
10 - 15 Lacs
Mumbai
Work from Office
JOB OVERVIEW: We are looking for an experienced and motivated IT Compliance Manager with expertise in SAP S/4 HANA implementation with manage IT compliance activities, ensuring systems and processes adhere to regulatory standards and organizational policies. The ideal candidate will play a key role in implementing and monitoring compliance controls, working closely with cross-functional teams to maintain a secure and compliant SAP S/4 HANA environment. KEY STAKEHOLDERS: INTERNAL Business Site / Central Partner functions IT Team (e.g. SAP/ Infra / Quality IT / Allied / SAP Basis) KEY STAKEHOLDERS: EXTERNAL IT Vendors IT Contractors/Consultants REPORTING STRUCTURE: Reporting to Associate General Manager QeC/CSV EXPERIENCE: Hands-on experience with IT compliance, quality management, and SAP systems, with a strong focus on SAP S/4HANA. 9+ years of experience in SAP S/4 HANA implementation and configuration. SKILLS AND COMPETENCIES Comprehensive understanding of SAP S/4 HANA architecture, modules, and functionalities. To have in depth understanding of regulatory requirements and guidelines required to comply IT systems in Pharma industry DI, ALCOA+, Part 11, Annex 11, GAMP 5 etc. Knowledge and Experience of Pharma domain Quality (QA, QC) (Good to have) Knowledge and experience on handling of CSV project related QMS e.g. Change control, deviation, CAPA and incidents. KEY ROLES & RESPONSIBILITIES To have good understanding and knowledge on SAP S/4 HANA application functionalities. Proven track record of successfully delivering multiple full life-cycle SAP S4 HANA implementation projects. Proficiency in managing integrations with other ERP systems or third-party applications. Accountable to ensure compliance of CSV documentation during various phases (project, operational & retirement) of software lifecycle (SLC) as per GAMP5, CFR Part 11/EU Annex 11 and Data integrity requirements. To define validation strategy and review CSV deliverables for IT projects for the applications SAP ECC, SAP S4 HANA, etc. To Review and approval of QMS documents e.g. Change control, Deviation, Incidents, CAPA, Extension, etc. as applicable. To ensure infrastructure (Network, Servers, Cloud, Database) are qualified as per required Quality Standards and required documents are in place. To support the initiatives undertaken by Quality e-Compliance team across the Central/PPL sites. To guide Central and Site IT teams for CSV, Data Integrity (DI), and Regulatory Compliance activities. To ensure 21 CFR Part 11, EU Annex 11 and GAMP 5 compliance across PPL sites, as applicable. To coordinate & build good working relations with Site/business users, Subject Matter Experts (SMEs) and IT operations team, Manage vendors / partners / support teams. QUALIFICATION: Graduate in Science/Pharmacy/Engineering Post Graduation Science/MBA (Desirable)
Posted 2 months ago
1 - 3 years
3 - 7 Lacs
Bengaluru
Work from Office
About The Role Roles and Responsibilities: Work experience of Accounts Payable/Procure to Pay Knowledge on GST, IGST, CGST, TDS, VAT Invoice Processing/Invoice audit/vendor payments experience must SAP end user experience in FI Module for Financial accounting is must. Advanced Excel, PPT, MIS report and other analytical reporting knowledge & experience is an added advantage. Knowledge about different kind of payment methods and payment term. PO and non PO invoices handling ? ? ? ?
Posted 2 months ago
1 - 3 years
3 - 7 Lacs
Pune
Work from Office
About The Role Roles and Responsibilities: Work experience of Accounts Payable/Procure to Pay Knowledge on GST, IGST, CGST, TDS, VAT Invoice Processing/Invoice audit/vendor payments experience must SAP end user experience in FI Module for Financial accounting is must. Advanced Excel, PPT, MIS report and other analytical reporting knowledge & experience is an added advantage. Knowledge about different kind of payment methods and payment term. PO and non PO invoices handling ? ? ? ?
Posted 2 months ago
20 - 30 years
500 - 1000 Lacs
Baddi
Work from Office
Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaining operational efficiency and equipment reliability. This role plays a pivotal part in inventory control, and CAPA closure, contributing to seamless production operations, compliance with regulatory standards, and effective resource utilization. Roles & Responsibilities • To maintain the facility as per cGMP, and GMP requirements of country where product is being exported and strict adherence of Good Engineering practices during task execution. Can handle Water system operation and maintenance. Can handle HVAC system operation and maintenance. Must have knowledge of RO membranes & EDI replacement and its troubleshooting. Must Have knowledge of SCADA system and cGMP documentation. Spare management, Vendor management, MIS reports etc. Do the planned work on time. e.g. PM, PR, PO's etc. To carry out upkeep round as per schedule and updating of the records. To follow the instructions relating to engineering operations and to ensure their strict implementation. Ensuring continuous improvements and engineering excellence. To follow good documentation practices. To ensure EHS procedures and practices are followed at site to achieve zero lost time accident and compliance. Responsible for documentation related to upkeep of water system and HVAC. Must have knowledge of RCA, FMEA, Change Control, deviation and other GxP documentation. You will be accountable for ensuring implementation of Good Engineering Practices (GEP) at Site. Qualification Educational qualification : A Diploma or a B.Tech in Mechanical or Electrical Engineering Minimum work experience : 5 to 8 years Skills & attributes: Technical Skills Responsible for documentation related to upkeep of water system and HVAC. Responsible of Operation oif water system and HVAC Managing contractors at site. Their Work permits etc. Water system Maintenance and upkeep of HVAC in proper manner. Spare management for water system and HVAC Spares Experience in managing RO Mem. and EDI maintenance plans. Ability to manage maintenance budget of an area/unit. Knowledge of GMP and GEP. Behavioural skills • Communication and collaboration skills to coordinate with cross functional teams, external contractors and agencies. • Attention to detail to ensure preventive maintenance, documentation, and inventory control. • Commitment to quality and compliance. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Posted 2 months ago
2 - 7 years
8 - 12 Lacs
Vadodara
Work from Office
Why Join Siemens? At Siemens, you will be part of a global leader committed to innovation, quality, and excellence. This role offers the opportunity to work on challenging projects, develop professionally, and make a significant impact in the electrical and instrumentation domain, particularly within power plant and renewable energy projects. If you are passionate about leading a talented team and driving technical excellence, we encourage you to apply. As Siemens Energy, "We energize society" by supporting our customers to make the transition to a more sustainable world, based on innovative technologies and our ability to turn ideas into reality. We do this by Expanding renewables Transforming conventional power Strengthening electrical grids Driving industrial decarbonization Securing the supply chain and necessary minerals Looking for a challenging role? If you really want to make a difference - make it with us Job Requirements The candidate will be responsible for reviewing engineering drawing thoroughly from design, manufacturing and site operation point of view. Evaluation of engineering drawing from factory machining facility perspective. Identify in-house or vendor level component machining challenges during project execution. Evaluation of engineering drawing from factory assembly perspective. Identify any assembly challenges during project execution and new product development. Evaluation of complete project based of site execution challenges and operational philosophies for different product fleet lines. Experience of machining, assembly and site execution is a critical aspect for this role in addition to basic design knowledge. We"™ve got quite a lot to offer. How about you? This role is based in Vadodara, where you"™ll get the chance to work with teams impacting entire cities, countries and the shape of things to come. We"™re Siemens. A collection of over 379,000 minds building the future, one day at a time in over 200 countries. We're dedicated to equality, and we welcome applications that reflect the diversity of the communities we work in. All employment decisions at Siemens are based on qualifications, merit and business need. Bring your curiosity and imagination and help us shape tomorrow.
Posted 2 months ago
3 - 8 years
11 - 16 Lacs
Bengaluru
Work from Office
Do you want to help create the future of healthcare? Our name, Siemens Healthineers , was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone to grow personally and professionally. Sound interesting? Then come and join our global team as "˜ Product Owner"™ at Advanced Therapies to drive continuous development and contribute towards high-quality new generation of angiographic solutions. Your tasks and responsibilities: You take responsibility to be the customer voice for your scrum team(s) You take responsibility to be the technically relevant for your scrum team(s) activities You take responsibility to ensure that your scrum team (s) work focuses on product backlog and prioritization based on scope that creates maximum value and is aligned with overall product strategy Own creation of user stories along with your scrum team. Own Acceptance Criteria for owned user stories. Provide scrum team backlog management, iteration/sprint planning, and elaboration/grooming of the user stories Work as part of and with cross-functional scrum teams and various stakeholders, including design/user experience, test engineering, system engineering, user experience and work across the product lines. Prepare Team(s) backlog along with scrum team for Program Increment Planning. Drive" Definition of Ready" for user stories and features before Program Increment Planning Work with Scrum team(s) and other System Engineer, Risk engineers and product manager to adequately help in feature refinements for purpose of program increment (PI) planning and PI roadmap planning Contribute towards slicing of EPIC / Capability into ART Features. Contribute towards EPIC / CAPABILITY getting pulled and sliced down to multiple ART feature, as needed. Participate in various stakeholder meetings like POPM sync meeting. Support product manager towards getting feature finalized according to "Definition of Done." You are responsible for authoring/reviewing documentation (specifications), development/preparation of appropriate system functional specification (having Design Inputs) owned by you. You are responsible for authoring/reviewing and development/preparation of appropriate system or sub system functional specification(s) as Design Inputs. Participate in Change Control Board (CCB). Supports proper Defect Management for Scrum Team defects. Ability to work as an individual contributor and a team player. Wish to go above and beyond the project work and contribute at product level activities including innovation. Your qualifications and experience: Bachelor"™s degree and around 9-13 years of product or project development experience in software or hardware preferably in a medical device/Med tech industry with technical competencies as mentioned below You have many years of professional experience in product development of medical systems as Product Owner You have gained experience in agile development (e.g., SAFe, SCRUM). You have Technical competencies as mentioned: Work experience or good understanding of technology stacks. Technical understanding of web development technologies and frameworks Good understanding of Cloud technologies like Azure or AWS (nice to have) Good understanding of Touch devices like Tablets and mobiles. Potentially you have gained experience as an expert on national / international standards and regulation (EN, IEC, UL, etc.) (nice to have) Potentially you have additional experience (expert status) on a relevant special discipline, Requirements-Engineering, System Integration You have in good knowledge and understanding of IEC, EN and ISO standards for medical Devices (nice to have) You have a good level understanding of SDLC process and IEE 29148 - International Standard - Systems and software engineering -- Life cycle processes -- Requirement's engineering Your attributes and skills: Your excellent fluency in English enables you to collaborate with your international colleagues Your strong analytical and results-oriented mindset, as well as your ability to drive reliable decision-making, set you apart from the rest "We lead by being lean"you take on a role as a Lean-Agile leader - knowing about the autonomy of agile teams, you focus more on influence than authority. You have outstanding communication, facilitation and coordination skills; working with intercultural and interdisciplinary teams comes easily to you.
Posted 2 months ago
2 - 5 years
3 - 5 Lacs
Pune
Work from Office
Analytical QA Reviewer - Officer: Looking for a candidate with 2 to 4 years of work experience as QC analyst / AQA reviewer in reputed pharma companies. Should have Knowledge of handling/ analytical data review of HPLC , FTIR , UV spectrophotometer , KF Autotitrator , Dissolution apparatus. Have Basic knowledge of CGMP , GDP , Data integrity . Should have Basic knowledge of OOS (Out of specification), OOT, OOC
Posted 2 months ago
7 - 12 years
35 - 50 Lacs
Hyderabad
Work from Office
Roles & Responsibilities 1. To perform In-process and Finished product tests for Assay, Related substance, Residual solvent, UOD, Dissolution, and Water content. 2. To perform Exhibit, Hold time and process validation samples analysis. 3. To Handle HPLC, GC, Dissolution, UV and KF systems and its maintenance. 4. To handle Empower software, sample sets loading and processing independently. 5. Good experience in chromatography. 6. Knowledge on Investigations, Deviations, OOT and OOS. 7. To handle SAP, LIMS and DCMS activities. 8. To follow good laboratory practices (GLP) and good documentation practices (GDP). Qualification Educational qualification: MSC chemistry, B-Pharm Minimum work experience: 5-7 years years in QC. Additional Information
Posted 2 months ago
6 - 10 years
0 - 0 Lacs
Vijayawada
Work from Office
Good experience & understanding of IT infrastructure and data centre technologies as well as following practices, - Servers (Dell is preferred ) Unix/Linux operating systems-
Posted 2 months ago
2 - 7 years
3 - 8 Lacs
Ahmedabad
Work from Office
Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities QUALITY ASSURANCE IPQA (Injectable), IPQA (OSD) & QMS / Documentation / Validation and Qualification (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. Injectable Manufacturing Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI OSD Manufacturing / Dispensing / QMS (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification B Sc / M Sc / B. Pharmacy/ M Pharmacy / Diploma Time and Venue : 17th May 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. Preferred candidate profile *Having relevant qualification as mentioned above can attend the scheduled walk-in.
Posted 2 months ago
3 - 5 years
2 - 5 Lacs
Chennai
Work from Office
business development - Warehouse PPC/BD-W/1312211 Contract Logistics PPL Head Office Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 3 - 5 years ShareApply Basic Section No. Of Openings 1 Designation Grade Assistant Manager - M3 Freshers/Experience Experience Employee Bonus One Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Logistics Private Limited Department Contract Logistics Country India State Tamil Nadu Region Chennai Branch PPL Head Office Skills Skill Sales & Marketing Skills Communication skills Customer Data Minimum Qualification Under Graduate CERTIFICATION No data available Working Language English Hindi Tamil About The Role Person should have experience in business development warehousing business and strong customer data base. person able to convert existing customers on a faced manner. Product knowledge and communication skills are essential capable enough to achieve the targets as per the time frame -from the date of joining within three JC business conversion should take place. .
Posted 2 months ago
1 - 2 years
7 - 10 Lacs
Hyderabad
Work from Office
Apply now » .buttontext67bbcd0b84b126cf a{ border1px solid transparent; } .buttontext67bbcd0b84b126cf a:focus{ border1px dashed #00a3e0 !important; outlinenone !important; } Currently at TechnipFMC? Apply here. Intern/Apprentice Subsea/Surface Engineering Location: Hyderabad, IN #job-location.job-location-inline {displayinline;} Employment type: Employee Place of work: Office Offshore/Onshore: Onshore .buttontext3b34abe12d83182e a{ border1px solid transparent; } .buttontext3b34abe12d83182e a:focus{ border1px dashed #5B94FF !important; outlinenone !important; } .buttontexta77353c8ab1a0824 a{ border1px solid transparent; } .buttontexta77353c8ab1a0824 a:focus{ border1px dashed #5B94FF !important; outlinenone !important; } TechnipFMC is committed to driving real change in the energy industry. Our ambition is to build a sustainable future through relentless innovation and global collaboration – and we want you to be part of it. You’ll be joining a culture that values curiosity, expertise, and ideas as well as diversity, inclusion, and authenticity. Bring your unique energy to our team of more than 20,000 people worldwide, and discover a rewarding, fulfilling, and varied career that you can take in anywhere you want to go. Job Purpose About The Role You are meant for this job if: Skills .buttontextb2a1d6d26c880f7c a{ border1px solid transparent; } .buttontextb2a1d6d26c880f7c a:focus{ border1px dashed #5B94FF !important; outlinenone !important; } Being a global leader in the energy industry requires an inclusive and diverse environment. TechnipFMC promotes diversity, equity, and inclusion by ensuring equal opportunities to all ages, races, ethnicities, religions, sexual orientations, gender expressions, disabilities, or all other pluralities. We celebrate who you are and what you bring. Every voice matters and we encourage you to add to our culture. TechnipFMC respects the rights and dignity of those it works with and promotes adherence to internationally recognized human rights principles for those in its value chain. Learnmore about TechnipFMCand find other open positions by visiting ourCareer Page. Follow us onLinkedInfor company updates. Date posted: Apr 29, 2025 Requisition number: 12941 Apply now »
Posted 2 months ago
3 - 8 years
3 - 7 Lacs
Hyderabad
Work from Office
ABOUT AMGEN 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. ABOUT THE ROLE Role Description We are looking for a skilled Validation Associate Analyst to ensure our Master Data Management solutions are of good quality , compliant and GxP validated . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data mastering solutions and pipelines follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities Plan, coordinate, and execute validation activities, including qualification and validation of data products and software applications. ? Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports and get reviewed and approved Ensure validation strategies meet regulatory requirements and company standards Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents and get reviewed, and approved Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. ? Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and data engineering teams to drive validation activities and meet project deadlines. ? Track the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. ? Ensure timely and effective completion of all validation activities in line with project objectives and schedules. ? Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. ? Identify opportunities for process improvements in validation activities. ? Stay current on new technologies , validation trends, and industry best practices to improve validation efficiencies. ? Collaborate and communicate effectively with the product teams. ? Basic Qualifications and Experience Master’s degree with 1 - 3 years of experience in Business, Engineering, IT or related field OR Bachelor’s degree with 2 - 5 years of experience in Business, Engineering, IT or related field OR Diploma with 6 - 8 years of experience in Business, Engineering, IT or related field Functional Skills: Must-Have Skills: 2 + years of experience in validation in a G x P -regulated environment (pharmaceutical, biotech, medical devices, etc.) Experience of working in software validation projects Strong experience on tools like ALM , JIRA etc Must have worked in Agile or SAFe projects Experience with automated and computer-controlled systems validation (21 CFR Part 11) Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation Candidate must be able to write validation scripts in ALM and execute them independently Experience with computer system validation and software validation is a plus Strong problem-solving and analytical skills Excellent communication and teamwork skills Good-to-Have Skills: Understanding of compliance and regulatory considerations in master data. In depth knowledge of GDPR and HIPPA guidelines . Good to have prior work experience in MDM domain Hand son experience on JIRA, Confluence Professional Certifications CSV Certified Agile or SAFe certified Soft Skills: Strong analytical abilities to assess and improve master data processes and solutions. Excellent verbal and written communication skills, with the ability to convey complex data concepts clearly to technical and non-technical stakeholders. Effective problem-solving skills to address data-related issues and implement scalable solutions. Ability to work effectively with global, virtual teams EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with 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.
Posted 2 months ago
5 - 9 years
12 - 16 Lacs
Hyderabad
Work from Office
HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission - to serve patients - drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager – Devices What you will do Let’s do this. Let’s change the world. In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery devices and combination products, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. Responsibilities: Support the development, communication, implementation, and maintenance of JAPAC regulatory strategic plans Lead and/or support JAPAC health agency engagements Lead and/or support JAPAC filing activities and associated health agency inquiries Support device design controls activities and documentation reviews Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions in the JAPAC region Perform change control regulatory assessments as it relates to JAPAC Develop and support implementation and maintenance of internal regulatory processes Perform device determination decisions for regulated items to be developed and/or used in JAPAC region Support supplier engagement teams and due diligence activities in the JAPAC region Review regulatory sections in development, quality, and supply agreements that impacts JAPAC region Support regulatory compliance initiatives in the JAPAC region What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree; or Master’s degree and 2 years of pharma/biotech and/or medical device regulatory affairs experience; or Bachelor’s degree and 4 years of pharma/biotech and/or medical device regulatory affairs experience Preferred Qualifications: Master’s degree in regulatory affairs, engineering, or life sciences 6 or more years of experience in medical device regulatory affairs Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development Experience in drug delivery device or diagnostics device regulatory submission process Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms
Posted 2 months ago
5 - 8 years
0 - 0 Lacs
Bengaluru
Work from Office
Experience -5 to 8 Years Skill: Labware LIMS Developer (Migration Project Experience is mandatory) Location: Bangalore Candidate should hold a Bachelor's degree in a computer system, engineer or Technical graduation. 6+ years of working experience in Labware LIMS, Web Services (REST & SOAP). Proficient in all technical aspects of Interfaces development (SAP), LIMS Basics, preferably Labware LIMS, Subroutines, Instrument interfaces. Good knowledge on the Labware databases. Work on the backlogs, fixing the bugs, and working on the change requests. Work experience on the Labware Migration projects . Very good technical understanding and hands on experience with software development projects. Proficient in usage of processes such as change control, version control, release management, service management and the related tools like JIRA, HPSM, GEAR, source code repositories. Excellent knowledge of GMP in the context of electronic systems. Required Skills Labware LIMS,Web Services,Labware Migration Projects
Posted 2 months ago
5 - 10 years
6 - 8 Lacs
Bhiwadi
Work from Office
Job Description: 1.Handling of QMS related activities i.e., CAPA ,etc 2.Handling of Market Complaint with related investigation. 3.Preparation, review and implementation of SOPs. 4.Handling of Internal Audit and related activities. 5.Preparation and handling of Audit related activities. 6.Preparation of Audit Compliance Report. 7.Preparation of Documentation, i.e., COA, COO, MSDS, TD. 8.Calibration/Validation of Instruments.
Posted 2 months ago
10 - 15 years
13 - 15 Lacs
Hyderabad
Work from Office
Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.
Posted 2 months ago
5 - 6 years
7 - 8 Lacs
Mumbai
Work from Office
Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applicable federal and state laws and regulations to ensure the company's books are compliant.
Posted 2 months ago
5 - 9 years
7 - 11 Lacs
Mumbai
Work from Office
Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applicable federal and state laws and regulations to ensure the company's books are compliant.
Posted 2 months ago
3 - 7 years
1 - 4 Lacs
Jhajjar
Work from Office
Roles and Responsibilities Ensure compliance with IPQA guidelines and regulations during production processes. Conduct regular inspections of manufacturing areas, equipment, and documentation to identify deviations from SOPs. Implement change controls by reviewing changes, conducting risk assessments, and ensuring effective implementation. Monitor CAPAs (Corrective Action Preventive Actions) to ensure closure within specified timelines. Collaborate with cross-functional teams to resolve quality issues and improve overall process efficiency. Desired Candidate Profile 3-7 years of experience in pharmaceutical quality assurance or related field. Strong understanding of IPQA principles, GMP regulations, and industry standards such as WHO GMP Guidelines. Bachelor's of Pharmacy required.
Posted 2 months ago
1 - 2 years
1 - 2 Lacs
Nagpur
Work from Office
Confidence Petroleum is looking for Documentation Executive to join our dynamic team and embark on a rewarding career journey. Preparing and maintaining all types of documents, such as user manuals, training materials, and technical reports Ensuring that all documentation is accurate, complete, and up-to-date Collaborating with cross-functional teams to gather information and develop comprehensive documentation Reviewing and editing documentation to ensure consistency and readability Developing and implementing documentation processes and procedures Staying current with industry trends and best practices in technical documentation Managing document version control and ensuring that all documentation is stored securely
Posted 2 months ago
5 - 10 years
5 - 9 Lacs
Mysuru
Work from Office
Please download the comprehensive job description, including the position summary, specific responsibilities, and qualifications . APPLICATION DEADLINE: Applications will be reviewed as they are received, so interested candidates should apply immediately.
Posted 2 months ago
1 - 2 years
2 - 6 Lacs
Mumbai, New Delhi, Hyderabad
Work from Office
Lake Chemicals Pvt.Ltd., (Sterling Lab), is looking for Quality Control- Senior 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 Qualification: MBA/BBA/BBM in Marketing Experience: Fresher / 1-2 years of experience in API Marketing
Posted 2 months ago
2 - 5 years
0 - 3 Lacs
Gandhinagar
Work from Office
About: Sahajanand Medical Division Medical division is approved by state and central licensing authorities and it delivers efficient performance to meet specific requirements. The SLTL brand stents embody that bold spirit, offering a unique blend of our leading-edge technologies and time-tested engineering With Technical Collaboration & Patent Design, the company started indigenous manufacturing of Coronary products, in 2009. The company has a dedicated in-house R&D department approved by DSIR (Department of Scientific and Industrial Research). We believe that every product we make should stand for something. Something more than expected. And thats why we dont manufacture products for stereotypes. We build them for you. Kindly go through our websites mentioned below for further details. Website: www.sltlmedical.com Roles & Responsibility: Handling QA - QMS activities Change Control Deviation Non-conformity documents Line clearance activities Document Issuance Work as an Internal Auditor Skill/Knowledge Required: Graduate / Post Graduate in Science, Pharma, Biomedical 2-5 Years work experience in Quality Assurance role. Preferred from Medical Device industry / Pharma Industry Interested one can share resume on placement@sltl.com/ or What's app at - 9099923320
Posted 2 months ago
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