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5.0 - 10.0 years
11 - 12 Lacs
Pune
Work from Office
Participate in FAT tests prior to commissioning on site. Is responsible for checking that the systems and plants at customer site is ready for start-up incl. I/O tests and mechanical inspection. Start-up and commissioning according to specified procedures incl. test of functionality and completion of SAT tests. Reporting of results incl. feed back to the project team. Training of customers operators and handing over of the installation. Help the project managers to ensure that plants and systems delivered to the customers are according to the specifications when shipped from AL. Participate in project reviews to secure that experience from previous commissioning jobs are brought back to new projects and new standard concepts. Execute performance reviews of installations already handed over to customers. Coach and mentor less experienced Quotation engineers. Check the quality of their work and help them resolve problems and issues. Site visit for trouble shooting and Audit Who you are Commissioning Engineer based in Pune to execute start-up, pre-commissioning, commissioning and training of modules, systems and plants at customer site. Audit of existing plant to check the performance of the plant. What you can be Chemical Engineer graduate, having relevant experience in the same field (Edible Oil). Minimum 5 Years to 10 Years of experience. Fluent in written and spoken English. Experience in engineering and commissioning You are proactive. You have good Cross-functional awareness. Reedy to travel (Domestic and International)
Posted 1 week ago
1.0 - 5.0 years
1 - 2 Lacs
Bengaluru
Work from Office
Will implement marketing strategies&campaigns for product promotion to doctors, effective in-clinic presentation to doctors, identifying & promoting right product for right doctors, retail chemist prescription audit, timely reporting&achieve targets Required Candidate profile Preferably D. Pharm, B.Sc having 1-3 year exp. in pharma ethical selling having high energy level, effective communication / presentation / convincing skills and proven track record of achievements
Posted 1 week ago
3.0 - 8.0 years
3 - 4 Lacs
Kota, Banswara, Ajmer
Work from Office
We are looking for active and friendly people to join our sales team in Rajasthan. Your main work will be to meet customers and tell them about our products. Roles and Responsibilities: Manage a team of field sales executives. Plan daily activity schedules and monitor productivity. Analyze territory performance and refine strategy. Train new hires on field processes. Collaborate with leadership on campaign planning. Salary: 4.00 LPA + Attractive incentives Required Qualifications: Any graduate with minimum 2+ year of field experience Quick learner with strong persuasion skills Must be ready to join immediately Bike and valid DL are mandatory Skills: Strong communication, negotiation, and leadership skills Target-driven and self-motivated Familiarity with medical sales regulations Willingness to travel across the state Interested candidate share there resume on +91 92652 97550
Posted 1 week ago
5.0 - 6.0 years
8 - 9 Lacs
Bengaluru
Work from Office
Primary Responsibilities Ensures software applications are accurate, complete and conform to all user, company and regulatory requirements by Planning, creating, and implementing automated verification processes Creating associated validation documentation using proper documentation methods Assisting in the development and maintenance of automated testing procedures, processes, and quality standards Performing troubleshooting methods as necessary to maintain a stable and effective automated testing environment Working with software developers to resolve issues and retest applications Evaluating and analyzing test results Participating in project team meetings as needed Updating automated test scripts by Maintaining scripts and associated test matrices Identifying new areas for regression testing Mentors junior validation staff by Assisting in the quality review of automated validation packages and providing related feedback Assisting staff with problem solving and troubleshooting issues Maintains Quality Service and Departmental Standards by Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs) Assisting in establishing and enforcing departmental standards including defining, documenting and implementing validation standards as needed Secondary Responsibilities Contributes to team effort by Training staff on departmental processes, validation protocol, testing techniques and documentation methods. Performing code reviews and offer feedback on best coding practices when necessary. Evaluating, monitoring and prioritizing workload of staff to ensure projects are on time; affecting change when necessary Offering technical and quality feedback/advice to both internal and external client. Working with internal staff including technical staff, project managers and applications developers to assist with the development of project specifications Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Performing other duties as assigned Maintains Technical and Industry Knowledge by Attending and participating in applicable company-sponsored training Qualifications: Education: Bachelor s Degree in Computer Science, Engineering, Life Sciences or related field required; Master s preferred. Experience: 4+ years experience in validation/software testing required Experience working with test automation tools such as Coded UI, Selenium, Ranorex, Test Complete preferred Experience working with computer software including Word, Excel and Access preferred 2+ years experience working with clinical trials and/or within pharmaceutical environment preferred Working knowledge of the drug development process including knowledge of FDA requirements for GxPs and 21 CFR Part 11 preferred Proven problem-solving abilities Additional skill set: Ability to adjust to changing priorities Strong understanding automated software QA methodologies Excellent attention to detail and orientation toward careful meticulous work Must be highly motivated, result-oriented, and possess the ability to handle multiple projects with multiple deadlines concurrently with minimal supervision Strong problem-solving, documentation and organizational skills Excellent oral and written communication skills Ability to project and maintain a professional and positive attitude Working conditions: Travel: 0-5% Lifting: 0-25lbs Other: Computer work for long periods of time This position description should not be deemed all inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs. Acknowledgement By electronically signing off on this document, I am acknowledging that I have received a copy of my job description and I understand my roles and responsibilities as it relates to my position. EEO Statement Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
Posted 1 week ago
7.0 - 10.0 years
8 - 13 Lacs
Pune
Work from Office
Aftermarket Manager- Indirect Sales Job Details | our company We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser s local storage. This includes cookies necessary for the websites operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve websites performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Modify Cookie Preferences Accept All Cookies Search by Keyword Search by Location Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Aftermarket Manager- Indirect Sales Edwards India Private Ltd Date of posting: Jul 12, 2025 Your Role Dealer policy & Agreement Finalise Dealer policy & agreement in alignment with Equipment sales team. Communicate with dealers & sign off in the beginning of each year. Define Dealer territory Set Service Product wise targets based on allotted Territory & its installed base Focus on long term Service plans Define Dealer Safety Stock & review periodically during in person visits. Prepare Dealer Price list including labour charges in alignment with local market & divisional price list Derive Dealer Loyalty plan & implement it in the beginning of each year Prepare Lost customers (related to dealer) regain plan & implement Develop Dealer team competency in terms of Sales in coordination with VTS Training academy & local VTS Technical support Review dealer Performance on monthly basis & take actions for improvement. Prepare dealer segmentation & derive Dealer development plan to move them to next level Interact with dealer end users/customers through joint visits. Offer customised solutions to align with customer expectations. Dealer Service leads tracking & close looping in C4C Degree in Mechanical / Electrical Engineering Minimum 7-10 yrs. experience in Service Sales field. Applicants who are already working as Team leader or Dealer Manager in similar type of industry is preferred. Knowledge in Service Sales & Value Selling Ability to build Network & aggressive team Ability to work in MS office environment Excellent presentation skill set SAP knowledge and familiar with Sales Management Stakeholder management across different levels within and outside of the organization Excellent communication style as to explain expectations, make decisions understandable and positively influence team - Strong ability to drive Service Sales Excellence Strong ability to coordinate multi stake holders to provide solutions Strong ability to manage meeting and performance reviews Practical in nature with good communication skills. Capability to Lead from front Self-Disciplined & punctual Ownership ability Flexible to adopt & absorb market changes In return, we offer you Have multiple interactions with different stakeholders internally and externally A culture known for respectful interaction, ethical behaviour and integrity where sustainability matters Potential to see your ideas realized and to make an impact on technically interesting projects New challenges and new things to learn every day Plenty of opportunities to grow and develop Global job opportunities, as part of the Atlas Copco Group Edwards is a leading developer and manufacturer of sophisticated vacuum products, exhaust management systems and related value-added services. Edwards solutions are integral to manufacturing processes for semiconductors, flat panel displays, LEDs and solar cells. They are also used within an increasingly diverse range of industrial processes including power, glass and other coating applications; steel and other metallurgy; pharmaceutical and chemical; and for scientific instruments in a wide range of R&D applications. Edwards has over 4,000 employees worldwide engaged in the design, manufacture and support of high technology vacuum and exhaust management equipment. Edwards has state-of-the-art manufacturing facilities in Europe, Asia and North America. When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. These cookies are required to use this website and cant be turned off. Provider Description Enabled SAP as service provider We use the following session cookies, which are all required to enable the website to function: "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data center "JSESSIONID" is placed on the visitors device during the session so the server can identify the visitor "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another Functional Cookies These cookies provide a better customer experience on this site, such as by remembering your login details, optimizing video performance, or providing us with information about how our site is used. You may freely choose to accept or decline these cookies at any time. Note that certain functionalities that these third-parties make available may be impacted if you do not accept these cookies. Advertising Cookies These cookies serve ads that are relevant to your interests. 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Posted 1 week ago
6.0 - 8.0 years
8 - 12 Lacs
Hyderabad
Work from Office
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com . Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azuritys success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief team/department description: The analytical team in Azurity Pharmaceutical is responsible for support of formulation development and related analytical activities for various formulations intended primarily for US market. Principle Responsibilities: Minimum 6 to 8 Years working experience in analytical research and development lab with hands on experience of Method development, Stability analysis in Solid Oral (tablets, Capsules), Oral suspension and Oral solution. Hands on experience on at least HPLC/ UPLC, GC, UV, IR, pH meter, Dissolution, KF titrator etc. Should have potential exposure on method validation/method transfer of different analytical test methods. Good understanding of GLP, GDP, Data integrity and Documentation practices in lab work. Preparation of SOP, Test methods, Validation/Transfer protocols and reports knowledge is added advantage. Good knowledge and exposure on Related test and impurity profile methods development is needed. Knowledge about regulatory requirements on analytical methods, characterization of standards, and impurities is needed. Experience in calibration of different instruments like HPLC, GC, UV, IR, pH meter, Dissolution, KF titrator is required. Qualifications and Education Requirements M.Sc. Chemistry/ Analytical sciences or M. Pharmacy (Chemistry, Analysis or Pharmaceutics By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.
Posted 1 week ago
4.0 - 6.0 years
12 - 17 Lacs
Hyderabad
Work from Office
A highly motivated and analytical Pharma Competitive Intelligence professional to join our growing team. You will be responsible for delivering timely, accurate, and actionable insights to support strategic business decisions, managing competitor monitoring projects, and producing in-depth market and competitive landscape reports. The ideal candidate should demonstrate strong cross-functional collaboration, clear communication, and the ability to work independently in a fast-paced, global environment. This is a critical role requiring immediate impact and deep CI expertise, along with a forward-looking mindset to leverage AI tools that enhance research workflows, accelerate insight generation, and improve overall efficiency. Key Responsibilities: Independently develop and deliver in depth, comprehensive CI deliverables including periodic monitoring, indication-based pipeline landscapes, competitor asset profiles, market landscapes, key event trackers, competitor approval timelines, conference coverage, newsletters etc. Analyze and triangulate information from multiple secondary data sources and propriety databases such as TrialTrove, PharmaProjects, Cortellis, Evaluate, DRG, AlphaSense, and more to deliver holistic competitor profiles and landscape assessments Develop client- ready outputs (slides or documents) with the best suited data synthesis and convincing visualization to convey key messages while maintaining rigorous quality checks on insights and outputs to ensure data accuracy and relevance Manage multiple CI projects under tight timelines interfacing with global clientele and prioritize requests based on the criticality and client expectations and strategic priorities Leverage advanced tools and innovative methods, including AI to enhance data collection, accelerate analysis, and improve efficiency and impact of deliverables by thinking beyond traditional approaches Understand business context about key client assets and competitor dynamics to monitor KITs/KIQs, and develop meaningful insights and recommendations from diverse data sources What You Bring: Experience: 4-6 years experience in competitive intelligence in pharmaceutical or life sciences industry Functional Skills: In-depth understanding of global pharmaceutical markets across development stages early pipeline, pre-launch, and marketed products including clinical development processes, regulatory pathways, and commercial considerations Strong experience in working with pharmaceutical databases including (but not limited to) BioMed tracker, PharmaProjects, Trial trove, IQVIA, Cortellis, Evaluate, DRG, AlphaSense Past experience of contributing to projects in but not limited to market landscaping, product/asset profiling, competitor benchmarking, pipeline assessments, conference monitoring, and triangulating data from multiple sources Proficient in Microsoft Office tools (PowerPoint, Excel, Word); ability to create compelling, insightful, and client-ready deliverables presentations and reports Awareness of and curiosity about AI/ML tools and their potential applications in CI workflows Behavioral Skills: High learning agility and a proactive mindset Resilient and adaptable in a dynamic, fast-paced work environment Team player with leadership potential, willing to take ownership and contribute to collective success Strong collaboration and interpersonal skills and work independently within a global and multicultural team (both virtual and in-person) Effective communication and articulation skills, ability to convey complex insights in a structured and impactful manner Strategic thinking to connect dots across data sets with attention to detail Good organizational, time management and priority setting skills, and the flexibility to multi-task Preferred Qualifications: Educational Qualifications: PhD/Masters Degree in Life Sciences. MBA from reputed institutes.
Posted 1 week ago
1.0 - 2.0 years
3 - 6 Lacs
Chennai
Work from Office
Investigator Payment Associate - India, Chennai - Hybrid, Office-Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking an Investigator Payment Associate to join our diverse and dynamic team. As an Investigator Payment Associate at ICON, you will play a crucial role in facilitating investigator payments, ensuring compliance with regulations, and reviewing the financial aspects of clinical trials. What you will be doing: Processing investigator payments accurately and timely according to study protocols. Maintaining documentation and records related to investigator payments in compliance with regulatory requirements. Discussing with internal teams to resolve payment discrepancies and address inquiries from investigators. Assert the development and implementation of processes to streamline investigator payment procedures. Assisting in the preparation of financial reports and analysis related to investigator payments. Your profile: Bachelor s degree in finance, Accounting, or related field. 1-2 years of experience in finance or accounting roles, preferably in the pharmaceutical or clinical research industry. KNwledge of regulatory requirements related to investigator payments (e.g., Sunshine Act, FMV). Strong attention to detail and ability to work accurately in a fast-paced environment. Proficiency in Microsoft Excel and financial software (e.g., SAP, Oracle). Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply
Posted 1 week ago
1.0 - 3.0 years
14 - 15 Lacs
Bengaluru
Work from Office
Responsible for assisting Project Management personnel with various tasks throughout the study lifecycle. ESSENTIAL DUTIES AND RESPONSIBILITIES: Assist with the Planning and Setup, Monitoring, and Closeout Phases of study management which may include: Database setup. Study documentation development. Equipment distribution/tracking. Report creation/distribution. Archival of study documentation. Coordinate Project Assurance meetings and assist with compiling meeting minutes and action items. Support financial components of study management including: Assistance with documentation/database updates due to scope changes. Follow-up related to invoice reconciliations. Preparation of reports in support of study forecasting activities. Facilitate issue management by documenting and tracking progress to ensure timely resolution to customer escalations. OTHER DUTIES AND RESPONSIBILITIES: Ensure compliance with timely training completion/documentation. Respond to customer inquiries and participate in customer calls/meeting upon Project Manager s request. Take the lead in managing various aspects of a project as requested. Other related projects and tasks as assigned. QUALIFICATIONS AND SKILLS NEEDED: Education : Bachelor Degree preferred. Experience : At least 1-3+ years of experience in pharmaceutical field (or related industry experience). Knowledge of the drug development process. Good organizational, interpersonal, time management, and prioritization skills Excellent verbal and written communication skills, including ability to communicate effectively in English. Detail oriented and responsive to inquiries and requests. Working knowledge of Microsoft Office products. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract. The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.
Posted 1 week ago
2.0 - 3.0 years
5 - 9 Lacs
Hyderabad
Work from Office
Job Description: Role : Executive Analytics Location : Hyderabad Job Purpose/Overview To ensure the Dry Pet Food products leaving the factory operation conforms to the MARS specifications through the assurance of raw materials quality & compliance to process parameters by demonstrating quality inspections, process monitoring & control. The R&D Associate shall assist the Quality & Food Safety In charge in managing the Site Quality Laboratory (Analytical) in terms of executing test plans in timely manner, follow GLP, & cost optimisation. Shall actively participate in design & implementation of QMP (HACCP) Job Responsibilities Coordinate & ensure Proximate profile is tested for Raw Materials, Intermediate and Finished products including new RM, Library samples and Complaint samples on NIR Assist in conducting the testing of Mycotoxin/Aflatoxins analysis using techniques like Chemwell-ELISA, HPLC. Test and release the Packaging Materials according to defined test plan Support to develop and stabilize the analytical techniques in-house as required Coordinate to update and maintain the trend records on different analytical testing s. Manage the consumables for analytical lab and arrange procurement Communicate the release status of received RM, PM and Finished Products to all stakeholders Maintenance of instruments and equipment s related to analytical lab Coordination and execution of third-party testing requirements from different internal stakeholders NIR calibration and maintenance. Support the implementation of Laboratory standard requirements in day-to-day operations in lab by adopting the new procedures and using the new template provided Support Lab & Sanitation Manager via Walk through and Internal audits in the plant and in house laboratory Job Specifications/Qualifications 1. Educational & Professional Qualification MSc Chemistry with first class (or)/ B.Tech Food technology or MSc- in any Life Sciences, with Chemistry as one of the subjects in B Sc. with first class. 2. Knowledge/Experience Minimum 2-3 years working experience in analytical or microbiological laboratory. Working experience with Food/ Pharma Company is preferable.
Posted 1 week ago
3.0 - 4.0 years
7 Lacs
Hyderabad
Work from Office
Job Description: Role : Executive Microbiologist Location : Hyderabad Job Purpose/Overview To ensure the Dry Pet Food products leaving the factory operation confirms to the MARS specifications through the assurance of raw materials quality & compliance to process parameters by demonstrating quality inspections, process monitoring & control through microbiological testing of samples. The Microbiologist shall assist the Quality control lab manager in managing the Laboratory (microbiology) in terms of executing test plans in timely manner, follow GLP, & cost optimization. Shall participate & support effectively in design & implementation of Food Safety Quality Management Systems (HACCP) and essential Pre-requisite programs (PRPs) for Dry Pet food plant. Job Responsibilities 1. Plant Responsibilities: o Conduct analysis of incoming raw materials, Finished products as per Microbiological test plan. o Conduct routine microbiological tests as per the Mars Micro verification standard. o Communicate the status of materials or products for release/hold/ rework/ reject o Ensure effective implementation of personal-plant hygiene, cleaning & sanitations programs in line with GMP standard o Ensure Calibration the laboratory testing & measuring equipment s as per calibration plan o Conduct microbiological analysis for intermediate products & finished products as per test plan o Learn & implement new testing methods, as required. o Track & report the microbiological performance using trend charts , suggest & follow up corrective & preventive actions o Maintain Lab testing data and relevant test records. Ensure timely completion of all testing and documentation. o Conduct Environmental Monitoring of plant by taking Swabs samples, Air Monitoring and water testing. 2. Suppliers Interface: Track supplier performance basis raw materials quality, microbiological contaminations, handle non-conformities & record Communicate materials/ suppliers related issues to Supply chain and follow up Conduct/ Co-ordinate analysis of Shelf life samples, Market samples & Concerned samples to track product performance and feedback Co-ordinate/ facilitate with external testing laboratories for analysis & records 3. Support Quality & Food Safety Systems: Support effective implementation of HACCP in the plant by ensuring cleaning sanitation. Assist in designing MRAs for raw materials by sharing the analysis outcomes. Support in CCP/OPRP verifications wherever applicable through Microbiological Samples collections, Testing and reports sharing. Support in GMP verifications at site. 4. Other Responsibilities: Demonstrate GLP & support Lab cost optimization initiatives Conduct Associate on-job and classroom training on Food Safety Management. Focus on personal-plant hygiene, cleaning & sanitation plans. Quality- Associate is responsible to ensure effective implementation of Mars QMP (Quality Management Process), Quality and Food Safety requirements including Personnel Hygiene and GMP stated by the Organization as applicable. Associate shall deliver through Respective Area/Process Standard Operating Procedures. Meet basic competency requirements mentioned in the job Role Skill Matrix to ensure Quality and Food Safety requirements are implemented to satisfactory level. SES-Overall responsibility to ensure the individual compliance to Mars Global/Asset conservation standards and other relevant local SES legislation. Responsible for implementing and maintaining all relevant SES Management systems in their respective work area. Responsible for understand risks and controls in their area, get appropriate training, report all incidents and ensure that SES objectives are captured as KRAs in TMS The incumbent would work collaboratively with other Executives Microbiology for supporting the deliverables of the Lab He/She would act along with other Executives Microbiology as interface to Suppliers related to Microbiology testing Media procurement, PCR vendors and External microbiology labs. Job Specifications/Qualifications 1. Educational & Professional Qualification MSc- Microbiology or B. Tech with Microbiology Knowledge/Experience 3-4 years experience in microbiology Lab Required experience with Food/ Pharma Company
Posted 1 week ago
2.0 - 7.0 years
1 - 2 Lacs
Chennai
Work from Office
Job Description Job Title: Customer Success Executive Experience: 6 months 2 years Employment Type: Full-time About SANeForce: SANeForce is a leading technology company specializing in Sales Force Automation, Distribution Management, and Cloud-based software solutions tailored for the Pharmaceutical, Healthcare, FMCG, Dairy, and Consumer Goods industries. With a client base across India and abroad, we are committed to delivering innovative solutions and building lasting relationships through exceptional customer support and product excellence. Job Summary: We are looking for a dynamic and customer-focused Customer Success Executive to join our International Voice Process team. The ideal candidate will have excellent communication skills, a customer-centric approach, and prior experience in handling international clients over voice support. You will play a key role in ensuring customer satisfaction, resolving queries, and helping customers maximize the value of our solutions. Key Responsibilities: Handle inbound and outbound calls from international clients (primarily English-speaking countries). Provide prompt and efficient support for queries related to our software products and services. Build strong relationships with clients by understanding their business needs and ensuring a positive customer experience. Collaborate with internal teams to resolve technical or functional issues efficiently. Follow up with customers for issue resolution and ensure timely closure of open tickets. Identify opportunities for upselling or cross-selling based on customer needs. Maintain accurate records of client interactions using CRM tools. Requirements: 6 months to 1 year of experience in international voice process/customer support. Excellent verbal communication skills in English. Strong interpersonal and problem-solving skills. Basic knowledge of CRM tools and customer service best practices. Ability to work independently and as part of a team. Preferred Qualifications: Bachelor s degree in any discipline. Prior experience in a SaaS or IT-enabled service company is an advantage. Knowledge of customer lifecycle and success metrics is a plus. What We Offer: A dynamic and collaborative work environment Training and development opportunities Exposure to international markets and clients
Posted 1 week ago
5.0 - 10.0 years
8 - 9 Lacs
Bengaluru
Work from Office
About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Planning and executing various analytical method development, validation for new products, comprehensive testing of API and finished dosages with all established regulatory and compliance and safety requirements. Review of laboratory data, instrument logbook and reports wherever applicable. Initiation of departmental CCRs and tracking the progress to execute the proposed changes through QMS system. Preparation of TAP (Transfer of Analytical Procedures) protocol and Report for various sites. Procuring respective samples and Impurities accordingly. Planning and executing the assigned TAP projects to various sites. Preparation, maintenance and archival of regulatory submission documentation like SOP, protocols, reports for method development and validation. Job Responsibilities Prepares working plan for assigned projects and provides timeline to Manager. Develops stability indicative analytical methods for drug substance and finished product Responsible for all activities in Analytical Development, including cGLP, documentation and implementation of departmental quality systems. Applies AQbD approach to analytical method development where applicable. Responsible for protocol preparation, planning, execution, review and report preparation of various analytical method validation parameters. Ensures analytical methods validation is conducted according to approved validation protocols in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines. Responsible for method verifications and publishing of analytical methods. Maintenance and archival of analytical method validation documents. Performs all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation. Performs all analytical tests for PE/PO samples, including assay, degradation products and dissolution. Performs all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing. Conducts other tests required for dosage submissions. Conducts lab investigations for OOS and OOT results. Raising Change control for various analytical activities (Method SOP and department SOPs) by QMS trackwise To prepare General, Operation and Calibration Standard Operating Procedures. Responsible for initiation, execution and completion of technology transfer and collaborative validation activities of analytical methods to and / or from other departments of Apotex wherever applicable. Responsible for technology transfer and Transfer of analytical procedures activity to support the supervisor. Communicating the requirements for the Leaders and within the team members for effective cGLP procedures and departmental quality systems to achieve all outcomes. With minimal guidance, performs troubleshooting on complex issues with respect to the stability of drug substances and drug products. To participate in the mandatory trainings to execute the day to day job responsibilities. Assist in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GLP. Develops and maintain strong relationships within Analytical R&D to ensure that the projects are delivered on time. Practice and up-gradation of knowledge with respect to cGMP. Performs all work in accordance with all established regulatory and compliance and safety requirements. Participates in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements. Ensures all instruments assigned with responsibility within group/department are well maintained. Performs the calibration of instruments in Analytical R&D and ensures the compliance as per cGLP requirements. Work as a member of a team to achieve all outcomes. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field. Knowledge, Skills and Abilities knowledge of the instrumentation such as HPLC, GC, UV, IR spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques. Knowledge in HPLC method development and method validation. Knowledge on preparation and review of various documents like SOPs, Formats, Protocols, Reports, analytical data, investigation and deviation reports. Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities Should possess troubleshooting knowledge on Instruments and analysis. Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems. Working knowledge of LIMS is an asset. Good written and verbal English communication skills. Experience BSc with 5 years or MSc with 4 years or PhD with 2 years experience in a pharmaceutical lab in an R&D environment. Chromatographic method development and validation. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
Posted 1 week ago
0.0 years
2 - 3 Lacs
Chennai
Work from Office
To perform IPQA activities at shop floor in every stage of OSD manufacturing and packing. Review of BMR & BPR. Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. Review of documents of respective areas and logbooks for adequacy and completeness. QA overview for receipt of material from warehouse to production. IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. Preparation & Review of process validation protocols and reports. Any job activity assigned by HOD
Posted 1 week ago
4.0 - 12.0 years
8 - 11 Lacs
Hyderabad
Work from Office
Career Category Information Systems Job Description Let s do this. Let s change the world. In this vital role you will collaborate with business partners, service owners and IS peers to develop predictive models and insights across the US Commercial Organization. This position will innovate and build significant business impact through the use of sophisticated analytics techniques to help Amgen with its mission to serve patients by helping them get the therapies they need. Flexible Commuter role to Amgen India office. You will work on-site 2-3 days a week. This position will be primarily responsible for: Working collaboratively with cross-functional teams on projects and/or programs with aims to systematically derive insights that ultimately derive substantial business value for Amgen and our patients Identifying business needs and proposing potential analytics approaches for solutions Crafting and deploying a framework to supervise the performance of various campaigns, and tactics at a granular level Leading measurement and tracking of various omnichannel CX enablement initiatives Supporting the development of data science, machine learning prototypes, proof of concepts and models for testing various omnichannel strategies Communicating analysis ideas, progress and results to leadership and business partners What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree ORdata science and/or analytics experience Master s degree and 4 to 6 years of data science and/or analytics experience OR Bachelor s degree and 6 to 8 years of data science and/or analytics experience OR Diploma and 10 to 12 years of data science and/or analytics experience Preferred Qualifications: Relevant work experience in campaign measurement, marketing analytics and resource optimization in the pharma domain Programming experience with Python, R, or SAS and experience with ML libraries like scikit-learn, MLib, or TensorFlow Experience working with large datasets, experience working with distributed computing tools (Spark, Hive, etc.) is a plus Ability to communicate analysis in a clear, detailed, and practical manner Passion for learning and staying on top of current developments in sophisticated analytics Biotech / Pharma experience What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com .
Posted 1 week ago
3.0 - 6.0 years
6 - 10 Lacs
Bengaluru
Work from Office
Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level. Provide support to management with insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives . Manage the quality assurance oversight of projects, assignments, training and staff. Essential Functions Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies. Oversee and participate in the documentation, reporting, and closure of compliance issues. Organize and deliver training to other IQVIA departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc. Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified. Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements. Serve as author of Quality Assurance Standard Operating Procedures ( SOPs) as assigned. Advise Quality Assurance management on system audit needs. Ensure the Quality Assurance database is maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status. Host customer audits, mock regulatory inspections, and regulatory facility inspections as needed Qualifications Bachelors Degree Pref 7 years Quality Assurance experience in pharmaceutical, technical, or related area. Equivalent combination of education, training and experience. Knowledge of word-processing, spreadsheet, and database applications. Extensive knowledge of pharmaceutical research and development processes and regulatory environments. Considerable knowledge of quality assurance processes and procedures. Strong interpersonal skills. Excellent problem solving, risk analysis and negotiation skills. Exceptional training capabilities. Effective organization, communication, team orientation, and leadership skills. Ability to work independently with initiative. Ability to manage multiple projects. Ability to establish and maintain effective working relationships with coworkers, managers and clients. . IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs. iqvia. com
Posted 1 week ago
6.0 - 7.0 years
8 - 12 Lacs
Bengaluru
Work from Office
Mgr, RA EU Generics Labeling Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Area of Interest Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Mgr, RA EU Generics Labeling Jul 21, 2025 Bangalore, India, 560064 Who we are The opportunity Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products. Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues. Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling. How you ll spend your day Responsible for creating and updating compliant English product information for EU procedures. Strategic planning and implementation of changes affecting multiple product information documents. Determination of an implementation plan and tracking the implementation of updates due to new requirements (e. g. new excipients warnings, QRD template update). Providing instructions and guidance to local RA (e. g. calculations due to new excipients warnings). Discussion of the content of product information for innovative products (pre- and post-approval) in project teams. Evaluate and approve change requests; coordinate submissions with EU regulatory units. Collaborate on patent-related issues with Global IP Group. Contribute to readability studies and ensure PIL readability and compliance with legal requirements. Adaption to reference medicinal product (generic, hybrid, biosimilar procedures). Preparation of Expert statements (justification) for type II variations. Providing scope of variation to regulatory affairs. Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates. Monthly monitoring and communicating safety updates from EU authority websites. Track reference product updates and legal/guidance changes affecting product information. Assess need for updates based on Company Core Safety Information (CCSI). Implement PV triggered and non-PV triggered safety updates (e. g. PRAC/PSUSA/PSUFU, Referrals (Articles 31 + 107i), article 30 procedures, etc. ) in line with SOPs; collaborate on safety-related actions with Pharmacovigilance and QA. Participation in Product Safety Group (PSG) Meetings. Implementation of internal signals (including determining PIL wording). Scientific Work & Authority Communication Respond to authority deficiency letters in collaboration with other departments. Coordinate creation and approval of packaging mockups, Braille, and specimens. Address authority queries and ensure compliance with EU regulations. Assist with training new team members Your experience and qualifications Experience: 6 to 7 years in relevant fields (medicinal information and EU labeling in the pharmaceutical industry) ideally in Regulatory Affairs. Education: Completed at least 8-semester university degree in natural sciences (e. g. , Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry), preferably with a PhD. Other: Advanced English (spoken and written), strong MS Office skills, knowledge of European pharmaceutical law and regulatory affairs. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Posted 1 week ago
1.0 - 6.0 years
8 - 9 Lacs
Bengaluru
Work from Office
Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Treasury Analyst I Jul 22, 2025 Bangalore, India, 560064 Who we are The opportunity The Treasury Analyst role includes technical or transactional responsibilities - primarily in payments, cash and liquidity management, inter-company funding, cash forecast and banking as well as more strategic and business partnering requirements. Communication and (internal) stakeholder management with higher management levels within the Global Teva organization is required in this process How you ll spend your day Supporting day-to-day treasury operation activities, including preparing daily cash position, investigations and monitoring payments process initiated by Operations Tracking and settle inter-company receivables and payables and manage activities across in-house banking Supporting FX conversions and derivatives operation activities. Playing an active role in promoting an advanced risk management culture, including awareness of the various foreign exchange exposures, ensuring timely & accurate booking of FX exposures (performed by accounting), awareness of translation differences on cash, etc. Preparing and supporting Guarantees and Letter of Credits when needed, according to the relevant policy The implementation of, and compliance with, all Treasury Policies & guidelines Support and lead complex and international ad-hoc projects and ad-hoc reporting Support systems implementation and modification to existing system and ensure timely delivery of all system testing and validation. Process documentations and certifications will have to ensure that all process are appropriately documented and periodically certified by team members on regular basis. Working on cash forecasting and working capital projects Your experience and qualifications University education in Accounting or Finance required CA Inter qualified is must. Minimum 1 year of relevant treasury experience is good to have Well versed with Finance world, latest trends, technology & best practices in the industry Experience in fast-paced multinational matrix organization Strong change management, communication and influencing skills Fluent verbal and written communication in English Hands-on and proactive; strong organizational skills Results driven and service oriented to internal and external customers Ability to work effectively under pressure Associate Director Treasury Already Working @TEVA The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Posted 1 week ago
2.0 - 4.0 years
2 - 6 Lacs
Chennai
Work from Office
Position Purpose The PSSR Aggregate Report Analyst creates documents pertaining to post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. These documents include but are not limited to integrated analyses of safety data in support of aggregate reports (e. g. , Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc. ), responses to regulatory queries on safety topics, post-marketing safety assessments, and Risk Management Plans and relevant documents. Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents. Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues. Provide oversight for internal or external (contractor) co-authors when required for a particular project or assignment (e. g. , Canadian Annual Report). Primary Responsibilities Communicate WWS s position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed. Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations. Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents. Deliver assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality. If overseeing the work of or leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team. Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance. Understand relationships and dependencies between documents and analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and ACOs. Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents. Develop and sustain constructive relationships within other Pfizer lines including country organizations. Identify potential areas for process improvements and possible solutions and communicate these to line management or appropriate functional line. Education Bachelors Degree in life sciences and 2+ years relevant medical experience such as, patient care, clinical trial experience / investigator, academic medicine, specialty training or pharmaceutical industry experience, ideally in safety, regulatory or clinical areas Advanced degree preferred (MD, DVM, PharmD, or Master s/PhD in relevant field) Experience and Attributes Able to execute routine analyses and interpret routine safety analyses with guidance from team members ( analytic skills) Understands regulatory guidance as it pertains to presentation and communication of benefit/risk and pharmacovigilance ( regulatory knowledge) Is able to synthesize analyses of aggregate or individual patient data into clearly written text under general supervision. (writing skills) Has basic understanding of medical concepts of the disease and the specific approach to treatment. Makes decisions that require choosing between multiple options to resolve moderately complex problems in standard situations. (analytic skills, and maybe interpersonal skills as well) Medical #LI-PFE
Posted 1 week ago
3.0 - 6.0 years
5 - 9 Lacs
Chennai
Work from Office
Position Purpose The PSSR Aggregate Report Analyst creates documents pertaining to post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. These documents include but are not limited to integrated analyses of safety data in support of aggregate reports (e. g. , Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc. ), responses to regulatory queries on safety topics, post-marketing safety assessments, and Risk Management Plans and relevant documents. Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents. Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues. Provide oversight for internal or external (contractor) co-authors when required for a particular project or assignment (e. g. , Canadian Annual Report). Primary Responsibility Communicate WWS s position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed. Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations. Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents. Deliver assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality. If overseeing the work of or leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team. Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance. Understand relationships and dependencies between documents and analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and ACOs. Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents. Develop and sustain constructive relationships within other Pfizer lines including country organizations. If assigned by manager, serve as the WWS point of contact for all document issues for a given product or set of products. Identify potential areas for process improvements and possible solutions and communicate these to line management or appropriate functional line. Education: Bachelors Degree in life sciences and 3+ years relevant medical experience such as, patient care, clinical trial experience / investigator, academic medicine, specialty training or pharmaceutical industry experience, ideally in safety, regulatory or clinical areas Advanced degree preferred (MD, DVM, PharmD, or Master s/PhD in relevant field) Experience and Attributes: Able to execute routine analyses and interpret routine safety analyses with guidance from team members ( analytic skills) Has comprehensive understanding of regulatory guidance as it pertains to presentation and communication of benefit/risk and pharmacovigilance ( regulatory knowledge) Is able to synthesize analyses of aggregate or individual patient data into clearly written text with minimal supervision. (writing skills) Has good understanding of medical concepts of the disease and the specific approach to treatment. Makes decisions that require choosing between multiple options to resolve moderately complex problems, some of which deviate from standard situations. (analytic skills, and maybe interpersonal skills as well) Medical #LI-PFE
Posted 1 week ago
4.0 - 7.0 years
6 - 10 Lacs
Visakhapatnam
Work from Office
Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. What You Will Achieve In this role, you will: Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements. Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution. Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations. Guide the writing, review, and approval of validation process documents and technical reports, ensuring adherence to the latest Pfizer Quality Standards. Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities. Manage routine Quality systems such as Change Control, Quality Agreement, Documentation, and Investigations, and coordinate testing with functional groups. Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering validation on site or network teams. Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations. Here Is What You Need (Minimum Requirements) High school diploma (or equivalent) with 8+ years of experience or associate s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience Proven expertise in Good Manufacturing Practices Strong working knowledge of various quality systems and processes Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System Excellent verbal and written communication skills Ability to work independently and in a team environment Bonus Points If You Have (Preferred Requirements) Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems Experience with sterile products and medical devices Strong analytical and problem-solving skills Strong organizational and time management skills Ability to mentor and guide other colleagues Experience in regulatory audits and compliance Quality Assurance and Control #LI-PFE
Posted 1 week ago
9.0 - 12.0 years
11 - 12 Lacs
Bengaluru
Work from Office
Designation: Assistant Manager Job Location: Bangalore Job Grade: 8-II The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1. 9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. Key Result Areas Role-specific: Maintain good aseptic behavior inside BMP4 facility. Perform all the Downstream activities like Assembly preparation, accessories arrangement for step, Dispensing of raw materials and consumables, Reconciliation of excess and unused raw materials and consumables Buffer Preparation, Harvest Clarification, Chromatography operation, Low pH and Intermediate depth filtration, Viral filtration, TFF Operation and 0. 2 filtration. Operating and cleaning of downstream equipment(s) as per standard operating procedures and EOP. Monitoring and process control of the specific Operations of the Downstream. Maintenance of Quality records. Perform In-process product sampling, sample submission and storage. Perform room owner responsibility for the assigned DSP area. Perform equipment/instrument ownership related responsibilities related to DSP. Initiate Complaint Slips (work orders) for DSP related areas and equipment. Coordinate with QA for line clearance. Maintaining process area All-time ready for Inspection/ audit purpose. Maintain facility and assigned zone all-time ready for visit and audit. Involve and support in execution of batches as and when required and perform error free operation as per Batch Manufacturing Record (BMR). Involve in shipment of samples / final product as per packing and dispatch record. Work proactively to meet all document(s) on time closure requirement. Execute the protocols related to Downstream related activity and equipment / instrument qualification. Involve in Shipment of samples /final product as per packing and dispatch record. Execute the batch activity as per BMR and report nonconformity to the supervisor. Issuance of annexures, RM, consumables and BMRs. Track the work order status and ensuring timely closure. Education and Experience Education Master s degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field. Industry Experience Minimum 9-12 years of relevant practical experience in Downstream Manufacturing for biopharmaceuticals, specifically with CHO cell lines for monoclonal antibodies, fusion proteins, etc. Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Pls visit us at https://syngeneintl. com/ to know more about us and what we do.
Posted 1 week ago
0.0 - 2.0 years
0 - 0 Lacs
chennai, vellore, cuddalore
On-site
Job Opportunity: Medical Coder Contact: HR Anu: + 91 9500408540 Position: Medical Coder Trainee Location: Chennai, Bangalore, Hyderabad, Thrichy Shift: Day Shift Working Days: Monday to Friday (Weekends Off) Job Description: Medical Coding involves converting text information related to healthcare services into numeric diagnosis (ICD-10 CM) and procedure codes (CPT) used for billing and records. Requirements: Knowledge of Anatomy and Physiology Good communication and interpersonal skills Basic computer skills Passion for healthcare and precision in work Eligibility: Candidates with the following qualifications are eligible to apply: Nursing : B.Sc. Nursing, GNM, DGNM Allied Health & Life Sciences : Sc. / M.Sc. in Life Sciences, Biology, Zoology, Advanced Zoology, Biochemistry, Microbiology, Biotechnology, Plant Biotechnology Sc. / M.Sc. in Paramedical Sciences, Clinical Nutrition, Medical Laboratory Technology, Medical Sociology, Epidemiology, Molecular Virology, Medical Biochemistry, Medical Microbiology Sc. in Physician Assistant, Accident & Emergency Care Technology, Audiology & Speech Language Pathology, Cardiac Technology, Critical Care Technology, Dialysis Technology, Operation Theatre & Anesthesia Technology, Nuclear Medicine Technology, Respiratory Therapy, Radiology & Imaging Technology, Radiotherapy Technology, Medical Record Science, Optometry Technology Bachelor of Science in Optometry Pharmacy , Physiotherapy , Dentistry , Biomedical Engineering Vacancies: 10 Positions Salary & Benefits: Salary (Fresher): 14,000 18,000 per month Performance Incentives: Up to 5,000 Additional Perks: Pick-up and Drop Facility Free Food Corporate Standard Benefits
Posted 1 week ago
2.0 - 6.0 years
0 Lacs
hyderabad, telangana
On-site
As a stem cells banking sales representative, your primary responsibility will be to generate prospective leads and convert them into productive sales. This is a full-time position with a day shift schedule. The ideal candidate will have 2 years of experience in the pharmaceutical industry, with a total of 3 years of work experience being preferred. The work location for this role is in person. Benefits for this position include commuter assistance. The expected start date for this role is 01/09/2024. If you are a motivated individual with a background in pharmaceutical sales and a passion for driving sales in the stem cells banking industry, we would love to hear from you.,
Posted 1 week ago
3.0 - 5.0 years
30 - 35 Lacs
Hyderabad
Work from Office
Career Category Regulatory Job Description 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. Manager, Global Regulatory Intelligence The Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director. This role often has a technology and data focus , managing the tools and information that drive the intelligence process. Key Responsibilities: Intelligence Gathering & Analysis: Assist in monitoring and analyzing the global regulatory landscape, and in developing intelligence reports and updates as directed by the RI Director. A core duty is to collect and synthesize new or updated local regulatory requirements obtained from Amgen s local regulatory teams, for the Manager s assigned areas of responsibility. This information feeds into the group s centralized knowledge base. The Manager helps execute the regulatory intelligence workplans by preparing agreed deliverables for example, compiling monitoring reports, bulletins, and landscape summaries that highlight regulatory changes or requirements relevant to upcoming filings. They ensure that these deliverables are coherent and actionable, providing clear recommendations or insights where appropriate . Tools & Data Management: Take ownership of the tools, databases, and documentation that support intelligence gathering and dissemination. The Manager is responsible for facilitating and maintaining these systems on a day-to-day basis. This includes ensuring that repositories of regulatory requirements and intelligence reports are up-to-date and accessible to stakeholders. Importantly, the Manager may also be expected to build or modify new tools and databases as needed, not just use existing ones. (For example, if a new tracking database or dashboard is required to capture regulatory changes, the Manager would play a key role in its development or configuration.) Emphasizing this in the job description sets clear expectations that the role involves technical initiative in improving intelligence systems. Cross-Functional Support: Work closely with other members of the Regulatory Policy & Intelligence team and with regulatory staff in various functions to ensure intelligence is applied effectively. The Manager engages with policy analysts, product regulatory leads, and other cross-functional team members to share findings and gather input. While the Manager may not lead cross-functional projects independently, they support these efforts by providing the necessary data or analysis. For instance, if a cross-product regulatory strategy project is underway, the Manager might supply the compiled country requirements or recent regulatory changes needed for decision-making. They help ensure that agreed intelligence deliverables are executed on time and that any intelligence requests from internal stakeholders are addressed promptly. Progress Tracking & Improvement: Monitor the progress of intelligence-gathering activities against the team s objectives and timelines. The Manager tracks their assignments (e.g., monitoring tasks or updates due) and regularly reports status to the RI Director. If there are delays or obstacles in obtaining information, the Manager flags these and helps troubleshoot solutions. Additionally, the Manager contributes to process improvement discussions identifying any inefficiencies in how intelligence data is collected or shared and suggesting enhancements. They participate in continuous improvement of the function s processes and tools, helping to refine workflows for greater efficiency and reliability. Knowledge & Skills: Regulatory Knowledge: A solid grounding in regulatory affairs processes and requirements is needed. The Manager should understand regulatory submission guidelines and procedures across different regions (major markets and smaller markets) and have familiarity with how local regulations impact drug development and filings. While they may rely on senior staff for deeper analysis, the Manager must be able to interpret regulatory documents or health authority guidance and extract key points. The ability to handle complex information and distill it into clear summaries is crucial often the Manager will be the first to review new regulations and must highlight what matters to Amgen s products. Attention to Detail and Analytical Skills: The role requires strong analytical abilities and attention to detail. The Manager will be dealing with regulatory texts, tracking changes, and inputting data into intelligence systems so accuracy is paramount. They should be skilled at comparing regulatory requirements and spotting differences or trends. At the same time, they need to maintain a big-picture view to recognize how a particular change might affect Amgen s global filing strategy. Being able to propose practical solutions or escalate important findings is part of this analytical skill set. Technical and Project Skills: Proficiency in using information systems and databases is important, as this role often acts as the power user of regulatory intelligence tools. Experience with managing or configuring databases, spreadsheets, or tracking tools will be useful. The Manager should also have good project coordination skills capable of managing their own workstreams, meeting deadlines, and juggling multiple intelligence requests or projects. Strong written and oral communication skills are needed to draft clear reports and to communicate findings to the team or other stakeholders. Additionally, a willingness to learn and even create new technical solutions (e.g., leveraging an internal SharePoint site or an intelligence software platform) is highly valued in this position. Qualifications: Education & Experience: It is recommended that candidates have at least a Bachelor s degree in a relevant discipline (such as life sciences or regulatory affairs) plus relevant experience in regulatory or drug development roles. An advanced degree ( Master s or higher) in a related field is a plus. While Amgen s internal templates for similar roles have sometimes listed lower educational minima ( e.g. associate degree or high school with significant years of experience), for a Regulatory Intelligence Manager it is preferable to require a Bachelor s degree as the minimum qualification . This ensures the candidate has a sufficient foundation to grasp complex regulatory information. In terms of experience, a few years of hands-on regulatory affairs or regulatory operations experience (for instance, ~3-5 years with a Bachelor s degree ) would likely be expected, given the need to work independently and with understanding of the regulatory context. Preferred Background: Relevant industry experience in pharmaceutical/biotech regulatory affairs or compliance is strongly preferred. Experience specifically with regulatory intelligence or policy tracking whether in a prior role or via project work would allow a new hire to hit the ground running. Familiarity with regulatory intelligence tools or subscription databases (such as Tarius or similar services) and experience interacting with global regulatory colleagues would also be advantageous . The ideal candidate will be one who not only has the technical skills to manage data and tools, but also the curiosity and insight to understand why regulatory changes matter and how to communicate those insights effectively.
Posted 1 week ago
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