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2.0 - 6.0 years

4 - 6 Lacs

Pune

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Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

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0.0 - 1.0 years

2 Lacs

Chennai

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Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for any graduation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Posted 17 hours ago

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4.0 - 8.0 years

6 - 10 Lacs

Mumbai

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The Apex Group was established in Bermuda in 2003 and is now one of the worlds largest fund administration and middle office solutions providers. Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully delivered on an unprecedented growth and transformation journey, and we are now represented by over circa 13,000 employees across 112 offices worldwide.Your career with us should reflect your energy and passion. Thats why, at Apex Group, we will do more than simply empower you. We will work to supercharge your unique skills and experience. Take the lead and well give you the support you need to be at the top of your game. And we offer you the freedom to be a positive disrupter and turn big ideas into bold, industry-changing realities. For our business, for clients, and for you The Role: Understand the global outsourcing policy and framework and support the Global Outsourcing Team in ensuring the business comply with this and supporting in annual refresh of policy and process. To join regular calls and meetings with the Global Outsourcing Team to shadow and learn the business and operating model from an outsourcing perspective. Support the regulated businesses across Apex with maintenance of the Nexus Assurance Navigator system. Take responsibility and ownership of Nexus Navigator and validation and integrity of data within. Work with various technology stakeholders across the business to ensure there is accurate and seamless data feeds and support with development of reporting in and out of the platform. At as project manager for any system, data or reporting projects and initiatives Support the regulated businesses across Apex with Outsourcing tasks within the platform Perform analytics on data outputs Create reports from excel outputs and support with development of dashboards to present data Support the India Outsourcing Lead, GSC and local businesses with maintenance of the Nexus Assurance Navigator system and to support with preparation of reports. Support the India Outsourcing Lead and Local MGT with amending, preparing and reviewing outsourcing spreadsheets Support the India Outsourcing Lead and Local MGT with signing of all outsourcing documents and uploading into the system Support with Nexus Assurance on-going development and system enhancement projects. Act as super user on Nexus, providing support globally and over time supporting with delivering training and guidance on the system Support with various outsourcing projects with internal stakeholders. Maintaining outsourcing registers in excel and on systems. Preparing and presenting quarterly and ad-hoc reporting packs. Assisting in audits including internal audits and risk assessments and reviews from an outsourcing perspective. Maintaining and updating trackers internally and ensuring data integrity and confidentiality of internal information. Be a member of the Global Outsourcing working group and take part in joining each of the initiatives/project teams that this group are tasked with. Preparation of annual due diligence reports Quality assurance and control The Skills: Strong communication and drafting skills including drafting of presentations and reports and supporting in writing policies and procedures Ability to learn and grasp new compliance/risk/regulatory concepts and understanding these across multiple global jurisdictions within the business. Strong work ethic. Adapting and flexible approach towards learning new systems and operational procedures. Ability to work under pressure and tight timelines, excellent time management and multi-tasking skills. Strong interpersonal, verbal and non-verbal communication skills. Team Player with excellent collaborative, analytical, problem solving and organisational skills. Result oriented, detail oriented, team player with ability to work effectively with minimum supervision, in a fast paced, complex and dynamic environment. Very strong MS Office skills (including MS Excel Outlook, MS Word, MS PowerPoint) DisclaimerUnsolicited CVs sent to Apex (Talent Acquisition Team or Hiring Managers) by recruitment agencies will not be accepted for this position. Apex operates a direct sourcing model and where agency assistance is required, the Talent Acquisition team will engage directly with our exclusive recruitment partners.

Posted 3 days ago

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0.0 - 1.0 years

2 - 6 Lacs

Chennai

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Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Language - Ability: English(International) - Intermediate About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Posted 4 days ago

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0.0 - 1.0 years

2 - 6 Lacs

Chennai

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Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Language - Ability: English(International) - Intermediate About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

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0.0 - 1.0 years

2 - 6 Lacs

Navi Mumbai

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Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for contract conversion Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

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0.0 - 1.0 years

2 - 6 Lacs

Chennai

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Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Good Communication skills and Any degree expect BE & B.TechGood Communication skills and Any degree expect BE & B.Tech Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

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0.0 - 1.0 years

2 - 6 Lacs

Navi Mumbai

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Skill required: Provider Network - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Any graduate with some Health care experienceAny graduate with some Health care experience Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

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1.0 - 3.0 years

2 - 6 Lacs

Bengaluru

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Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Ability to meet deadlinesAbility to perform under pressureAbility to work well in a teamAdaptable and flexibleAgility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

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12.0 - 17.0 years

14 - 19 Lacs

Hyderabad

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Job Area: Finance & Accounting Group, Finance & Accounting Group > Global Accounting Ops Center General Summary: Job Overview The EMEA Payroll Staff will support the Qualcomm EMEA Payroll function, its processes, and internal or external relationships with General Accounting, Human Resources, Legal, Benefits, Employee Relations, Stock Programs, IT, Tax Auditors, ADP, and other related entities. This position will be responsible for developing, implementing, and maintaining processes that will contribute to efficient payroll processing for 5,000+ employees across multiple EMEA countries. This position will report to the Payroll Manager, located in Hyderabad, and will be responsible for coaching and guiding junior team members. The ideal candidate for this position is a people manager with 12+ years of experience, including a minimum of 3+ years in people management. We are looking for an individual with demonstrated experience in multi-country accurate and timely payroll processes who can effectively communicate with a global team. Responsibilities Own the operations of EMEA payroll for countries such as the UK, Ireland, France, Sweden, Netherlands, etc. This may include directly managing the EMEA payroll teams processing of monthly payroll, including ESPP and RSU stock reporting, benefits, tax, and social insurance requirements and reporting Timely review and first approval of multiple monthly payrolls for the accuracy, completeness and compliance Ensure compliance in operational controls around critical payroll processes such as new hires, terminations, and one-time payments Collaborate closely with the global payroll team and payroll partners on payroll processing, department initiatives, and projects Analyze payroll processes and controls, identify opportunities for improvement, and ensure global process consistency where applicable Liaise with external auditors and manage payroll-related audits Perform other special projects and analyses as directed by management Keep an eye on payroll KPIs and lead from front to improve them Minimum Qualifications Bachelors degree or equivalent foundation degree Certified Payroll Professional certification- good to have 10-12 years of total EMEA country payroll experience Demonstrable experience of mentoring junior team members Experience working in a multinational organization Expert skills with ADP Global View and Workday Excellent understanding of payroll systems, data workflows, and root cause analysis Current knowledge of applicable tax, social security, and other compliance requirements across multiple EMEA countries Fluent in spoken and written English Knowledge of taxable and non-taxable earnings and expenses; payroll tax laws and complex employee benefit programs impacting payroll Proven experience in designing and implementing processes, controls, and systems Solid understanding of equity-related transactions (RSU, ESPP gain) Ability to handle multiple tasks, set priorities, and meet deadlines in a high-volume, fast-paced environment High degree of accuracy, attention to detail & strong Excel and numerical skills Strong knowledge of payroll accounting and reconciliations Outstanding written and oral communication, organizational, and leadership skills Preferred Qualifications Masters degree in accounting Proficiency in French or any other European language Hands-on payroll knowledge of France, Sweden, and UK payrolls Any payroll certification is a plus End-to-end project experience with ADP Global View implementation Exposure or experience in mergers and acquisitions Minimum Qualifications: Bachelor's degree. 6+ years of Finance, Accounting, or related work experience.*Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Job Overview The EMEA Payroll Staff will support the Qualcomm EMEA Payroll function, its processes, and internal or external relationships with General Accounting, Human Resources, Legal, Benefits, Employee Relations, Stock Programs, IT, Tax Auditors, ADP, and other related entities. This position will be responsible for developing, implementing, and maintaining processes that will contribute to efficient payroll processing for 5,000+ employees across multiple EMEA countries. This position will report to the Payroll Manager, located in Hyderabad, and will be responsible for coaching and guiding junior team members. The ideal candidate for this position is a people manager with 12+ years of experience, including a minimum of 3+ years in people management. We are looking for an individual with demonstrated experience in multi-country accurate and timely payroll processes who can effectively communicate with a global team. Responsibilities Own the operations of EMEA payroll for countries such as the UK, Ireland, France, Sweden, Netherlands, etc. This may include directly managing the EMEA payroll teams processing of monthly payroll, including ESPP and RSU stock reporting, benefits, tax, and social insurance requirements and reporting Timely review and first approval of multiple monthly payrolls for the accuracy, completeness and compliance Ensure compliance in operational controls around critical payroll processes such as new hires, terminations, and one-time payments Collaborate closely with the global payroll team and payroll partners on payroll processing, department initiatives, and projects Analyze payroll processes and controls, identify opportunities for improvement, and ensure global process consistency where applicable Liaise with external auditors and manage payroll-related audits Perform other special projects and analyses as directed by management Keep an eye on payroll KPIs and lead from front to improve them Minimum Qualifications Bachelors degree or equivalent foundation degree Certified Payroll Professional certification- good to have 10-12 years of total EMEA country payroll experience Demonstrable experience of mentoring junior team members Experience working in a multinational organization Expert skills with ADP Global View and Workday Excellent understanding of payroll systems, data workflows, and root cause analysis Current knowledge of applicable tax, social security, and other compliance requirements across multiple EMEA countries Fluent in spoken and written English Knowledge of taxable and non-taxable earnings and expenses; payroll tax laws and complex employee benefit programs impacting payroll Proven experience in designing and implementing processes, controls, and systems Solid understanding of equity-related transactions (RSU, ESPP gain) Ability to handle multiple tasks, set priorities, and meet deadlines in a high-volume, fast-paced environment High degree of accuracy, attention to detail & strong Excel and numerical skills Strong knowledge of payroll accounting and reconciliations Outstanding written and oral communication, organizational, and leadership skills Preferred Qualifications Masters degree in accounting Proficiency in French or any other European language Hands-on payroll knowledge of France, Sweden, and UK payrolls Any payroll certification is a plus End-to-end project experience with ADP Global View implementation Exposure or experience in mergers and acquisitions Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail or call Qualcomm's toll-free number found . Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact .

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2.0 - 4.0 years

5 - 12 Lacs

Navi Mumbai

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Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Review Associate in Mumbai, India to join our Global Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Comprehensive manual review of clinical data collected in trials Development of clinical review guidelines for specific therapeutic areas Interface with Data Management team to assure query resolution Seeking specialization in following therapeutic areas: Oncology Hematology Infectious Disease Endocrinology Metabolic disorders Qualifications Bachelor’s Degree in Nursing / Medicine, or more advanced clinical degree Professional / or Post-Qualification Nursing experience, preferably in Oncology and Hematology background General knowledge of clinical trial processes and/or experience working with clinical data Experience with using MedDRA and WHO Drug dictionaries will be a plus. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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2.0 - 7.0 years

3 - 8 Lacs

Ahmedabad

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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 Injectable Manufacturing & Visual Inspection 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 / QMS (Senior Officer / Officer / Executive) Experience - 02 to 07 Years Qualification – B. Pharmacy/ M Pharmacy Engineering (Instrumentation / Process Equipment Maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification – BE / B Tech Time and Venue : 14th June 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. *Having relevant qualification only can attend the scheduled walk-in.

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10.0 - 15.0 years

10 - 12 Lacs

Nagpur

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Role & responsibilities 1. Shall responsible to review implementation & maintain of the Quality Management system with the regulations. 2. Determining, negotiating, and agreeing on in-house quality procedures, standards and specifications 3. Checking & Maintaining of Master Documents related to the QMS system. 4. Shall responsible to review filled Batch Production control record & analysis report for batch release. 5. Responsible for coordinate validation activity and validation protocols. 6. Responsible for control and approve deviations whenever raised in the concerned department and record the deviations. 7. Review and approval of the standard operating procedures for other concerned departments. 8. Responsible to plan and carry out internal audits & MRM. 9. Responsible for Coordinate with QC/Production for handling and investigation of Market complaints. 10. Responsible for conducting on-going training programs for new recruits and retraining for existing employees of concern department on the topic of SOP, GTP, GLP cGMP, WHO, ISO, etc. whenever required or as per schedule & Responsible for verifying the effectiveness of training programs system. 11. To check and approve artworks in coordination. 12. Verification and approval of the change control whenever the change in the document, facility, process, and equipment. 13. Verification and approval of documents concern to the production process, analysis including quality system. 14. Responsible for verifying the effectiveness of corrective action and preventive action systems. 15. Responsible to review & maintain system represent in QA department SOPs like OOS, OOT, (document record, storage & retention), Document control, APQR, Calibration, Trend data, etc. 16. Should have better co-ordination with QA, Production, QC, Engineering & Maintenance, for implementation of cGMP and also the electrical department. 17. Responsible for complying with all regulatory queries during any inspection and audit. 18. Responsible for application to FDA, FSSAI, Kosher, Halal, ISO, and others for any approval like Technical person, License/Renewal License, and additional Product, GMP. 19. Also responsible to work on time and to ensure TAT (Turn Around Time) given by Directors, any other job assigned by Superior. 20. Ensuring the manufacturing processes comply with standards at both the national and international levels. Job Type: Full-time

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3.0 - 8.0 years

4 - 6 Lacs

Fazilka

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JD @ QC Executive will ensure that products meet quality standards & regulatory requirements with analyzing samples, conducting tests, maintaining documentation & more Accommodation, Meals & Transport from client side Saturdays are Half day

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2.0 - 7.0 years

2 - 7 Lacs

Hyderabad

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Walk In Drive For Quality Control Department In Formulation Division @ Corporate Office Department:- Quality Control Qualification :-BSC | B Pharmacy | MSC | M Pharmacy Experience :- 2 To 8 Years Skills :- HPLC | GC | Dissolution | IP/FP | Stability (OSD & Injectables) | USFDA | Regulatory approvals Division :- Formulation Interview Date:- 15-06-2025 (Sunday) Interview Time :- 9.00AM TO 2.00PM Work Location:- MSN Formulation Unit II, Kothur & MSN Formulations Unit- V, RK Puram Venue Location:- MSN Corporate, H. No. 2-91/10 & 11 /MSN, Whitefield's, Kondapur, 5000845 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

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4.0 - 9.0 years

4 - 9 Lacs

Hyderabad

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Handling of all Vendor Management related activities including qualification of Vendors, Service Providers, Contract Manufacturing and Contract Testing Laboratories across R&D, API and Formulation units of Biological E, pharma divisions. To perform On-site audits as part of vendor audits, contract testing laboratories, contract manufacturing, external service vendors qualifications. Initiation and Review of Quality Management Systems (QMS), including Change controls, Deviations, Investigation reports and CAPAs. To perform Risk assessments related to Vendor, Contract Testing Laboratories and Contract Manufacturing and Service Provider qualification related activities. Preparation & review of Quality agreements & Technical agreements. To provide support / relevant information to the customers / suppliers as per the requirement and to provide remediation plans for the audit observations, if any To schedule, perform the self-inspections and review the Self-Inspection reports and relevant documents as applicable. To facilitate and review the performance of quality system through the review of QMS documents for Management Review Meetings. To co-ordinate for Management Review Meetings. To review and monitor the effectiveness of system changes and adequacy of CAPAs and post closure effectiveness checks. To track the health authorities observations at the Site and R&D and verify the compliance. To coordinate with the team for preparation and implementation of SOPs pertaining to Corporate Quality.

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20.0 - 25.0 years

20 - 30 Lacs

Visakhapatnam

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Hi Jobseeker, Greetings from Laurus Labs Ltd...! Please find the below Opening for Packing (OSD-Formulations) at Laurus Labs Ltd - Visakhapatnam. Department : Manufacturing- Packing Designation : Asst.General Manager Exp : 20-25 years Interested candidates can send their resume to Sarvani.gontu@lauruslabs.com and please send the below details for further process. Total Exp : Current CTC : Expected CTC : Notice Period : Regards, HR Team Laurus Labs Ltd

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4.0 - 5.0 years

3 - 7 Lacs

Chennai

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Prepare and submit regulatory documentation for new and existing products. Monitor and interpret global regulatory requirements relevant to physiotherapy and medical equipment. Maintain regulatory compliance throughout the product lifecycle. Interface with regulatory agencies, notified bodies and external consultants. Ensure accurate and timely product registrations in target markets. Maintain up-to-date Device Master Files (DMF) and Technical Documentation. Support clinical evaluation and risk assessment documentation where required. Ensure products comply with applicable regulations, standards and guidelines Manage change notifications, renewals, amendments and post-market surveillance requirements. Support A for audits, CAPAs, internal documentation practices and inspections from regulatory bodies. Provide regulatory guidance to R&D, QA, Marketing during product development and changes. Review and approve labeling, packaging and promotional materials to ensure compliance. Collaborate with external consultants, legal teams or distributors for country-specific compliance. Monitor regulatory changes and industry updates across markets. Participate in external seminars, forums and internal training to build regulatory awareness. Supporting and enabling effective and efficient communication that results in operational excellence. Skills required: Degree in Biomedical Engineering, Pharmacy or related field. 36 years of regulatory experience in the medical device industry. Strong knowledge of regulatory frameworks (US FDA, EU MDR, CDSCO, ISO 13485). Experience with regulatory submissions and product registrations. Excellent technical data interpretation skills including problem solving Excellent oral and written communication skills with strong presentation skills Demonstrate subject matter and area expertise Excellent computer skills; Good knowledge of document management systems Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

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6.0 - 8.0 years

7 - 9 Lacs

Ahmedabad

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Role & responsibilities Review and approve product test license, Import license for RLD and API. Review and approve standard operating procedures (SOPs) of equipment, instruments & facilities. Plan and execute reverse engineering of RLD and marketed products. Conduct Pre-formulation and formulation studies to evaluate the physical and chemical properties of drug substances and drug products. Plan and optimize formulation for Injectable dosage forms. Compile, review and approve technical documents, including Formulation Development and Stability study protocol reports. Plan and perform stability studies to ensure formulation meets stability requirements. Compile, review and approve API, Formulation stability reports. Ensure compliance with regulatory documents and company quality standards. Coordinate with Analytical, Regulatory, Stores, Purchase, Project management and Development Quality Assurance teams to support product development and regulatory submissions. Maintain laboratory equipment and ensure proper calibration and maintenance. Participate in technology transfer activities to manufacturing sites. Prepare FD lab for agency audits and customer visits. Other roles and responsibilities assigned by the FD Manager and R&D Head. Preferred candidate profile Master's degree in Pharma or related field Must have 06 - 08 years of Experience in Formulation Development Must have 04 - 06 years of team handling role in R&D Centre

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4.0 - 6.0 years

5 - 7 Lacs

Ahmedabad

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Role & responsibilities Prepare, review and submit regulatory documents for new drug applications, product registrations, amendments and renewals to the US, Brazil, EU, India and State Level authorities. Regulatory Submissions : Prepare and submit regulatory documents, including INDs (Investigational New Drug Applications) and NDAs (New Drug Applications) to regulatory authorities. Compliance and Licensing: Ensure compliance with regulatory requirements of US, Brazil, EU & India. Liaise with regulatory authorities for drug licensing, including product registrations, renewals and manufacturing licenses for local and international markets. Ensure timely submission of import licenses and NOcs (No Objection Certificates) for imported pharmaceutical products. Regulatory Strategy: Provide strategic input on regulatory requirements for new product development, lifecycle management and post-market activities, including regulatory intelligence gathering and competitive landscape analysis. Cross Functional Collaboration: Collaborate with R&D, Clinical, Quality, Manufacturing and Marketing teams to ensure alignment with regulatory strategies and compliance. Regulatory Health Authority Communication: Act as a liaison between the company and regulatory agencies to address questions or requests regarding regulatory fillings and approvals. Documentation and Reporting: Maintain accurate and up-to-date records of regulatory agencies submissions, communications with regulatory authorities and product approval status. Regulatory Training: Assist in training internal teams on regulatory requirements and best practices to ensure overall compliance across departments. Audit and Inspection Management: Coordinate with regulatory bodies in the event of audits, inspections or investigations. Preferred candidate profile Education: Bachelor's degree in Life Sciences (Pharmacy, Biology, Chemistry or related field). Advanced degrees (e.g. Master's or Ph.D.) are a plus. Experience: Minimum 05 -07 Years of experience in Regulatory Affairs, with a focus on regulatory submissions and drug licensing in the pharmaceutical industries. Knowledge: In-depth knowledge of regulatory requirements (FDA, EMA, ICH, etc.) drug development processes and regulatory submission strategies.

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2.0 - 7.0 years

2 - 7 Lacs

Hyderabad

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Walk In Drive For Quality Control Department In Formulation Division @ Bollaram Department:- Quality Control Qualification :-BSC | B Pharmacy | MSC | M Pharmacy Experience :- 2 To 8 Years Division :- Formulation Interview Date:- 08-06-2025 Interview Time :- 9.00AM TO 2.00PM Work Location:- MSNF-II , Kothur | MSNF-V, Rk Puram Venue Location:- Plot No- 42, Anrich Industrial Estate, Bollaram Village, Hyderabad, Telangana 502325 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Quality Control Formulation ( HPLC,GC,UV,Dissalution, LCMS, GCMS). About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

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10.0 - 15.0 years

10 - 14 Lacs

Vapi, Daman & Diu

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Role & responsibilities : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quality Audit and maintain the company anytime audit ready. Participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs & NCs. To monitor & handle market complaints. Conduct Management review at site. Conduct Calibration of instrument & Maintain Calibration Matrix . Ensure that a respective Change Control procedure is in place and adhered to . Process validation protocol preparation & implementation. Provide leadership and expertise on all aspects of product regulatory compliance to ensure that products are successfully introduced and maintained domestically and globally pursuant to regulatory compliance. Must be capable to handle all types of Audit. To Lead and face the regulatory audits and close all queries and NC in stipulated time. To maintain all documents related to compliances. Create Maintain & update Device Master/ Product Technical File. Preferred candidate profile: Graduate in Science or Engineering . Post Graduation preferred. Thorough Experience in quality and regulatory areas. Thorough experience in ISO 13485, GMP, US FDA, EU MDR, CDSCO, ISO 9001. Regulatory functions throughout the organization including monitoring , improvement , audits, and team building. Thoroughly conversant with technical documentation requirement and preparation. Excellent MS office skills. Should have faced multiple audits from multiple agencies Should have thorough knowledge of the applicable standards Perks and benefits: Medical Insurance for Spouse , 2 Kids Below 18 years upto Rs. 3lac.

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2.0 - 4.0 years

8 - 12 Lacs

Mumbai

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Dossier Power House

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8.0 - 13.0 years

10 - 15 Lacs

Mumbai

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Role & responsibilities :- Job overview :- The role requires strong analytical data review skills and experience with various QC instruments . The position involves supporting their North American sites , Potentially requiring the candidate to work according to US time zone. Key Responsibilities & Required Experience: Strong exposure to Analytical Data Review and electronic data review from QC instruments such as HPLC, GC, Dissolution Apparatus, and Malvern 3000 Thorough understanding of Quality Control investigations, including Lab Incidents, OOS, and OOT Preparation and Review of Method validation, Method Transfer, Method Verification and Equivalency documents, etc Review of Analytical raw data, Chromatography, and LIMS for Raw Materials/In-process/Finished Products. Preparation and Review of new SOPs. Candidates must have relevant experience in Oral Solid Dosage (OSD) formulations and/or Active Pharmaceutical Ingredient (API) processes. Kindly note the following: The selected candidate will support one of their sites in North America and will be required to work as per the US time zone . Strong communication skills are essential for this role.

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11.0 - 16.0 years

35 - 40 Lacs

Ahmedabad

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Job Description: Extensive knowledge of ANDA & ANDS submission activities and post-approval procedures and related ICH, USFDA and Health Canada related guidelines. API DMF review with respect to complete USFDA regulatory requirement. Thorough knowledge of Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. Ability to assess the dynamic change cases with respect to ICH Quality / post approval USFDA guidance and Knowledge of Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling Finalization of the Annual Report with required submission data as per USFDA guidance and ensuring its submission as per stipulated timeline. High quality review of entire submission package to avoid any major deficiencies for submitted supplements. Having knowledge about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames. Ensure to better management of major supplements submissions and approval process. Coordination with Cross Functional teams for the documents acceptance as per regulatory requirements. Ensure the no delay in submission always keen to adopt all regulatory submission requirements for complete submission. Maintain regulatory information as per current department practice. Having good Regulatory review and communication skills. Having good team management skills

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