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2.0 - 6.0 years
4 - 6 Lacs
Pune
Work from Office
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
Posted 4 months ago
2.0 - 7.0 years
3 - 8 Lacs
Panvel
Work from Office
The reputed pharmaceutical company engaged in development, manufacturing and marketing of oral solid dosages forms in regulated market. We are looking for competent, growth-oriented professional in Quality Assurance and Quality Control profiles for our USFDA & EU-GMP approved OSD manufacturing facility at N-32, Additional Patalganga MIDC, Tal.- Panvel, Dist.- Raigad.Roles and Responsibilities Ensure compliance with cGMP guidelines during formulation development, solid oral manufacturing, and OSD production. Conduct analytical method validation, stability studies, and quality control activities to ensure product quality. Develop and maintain documentation for batch records, test results, and ...
Posted 4 months ago
2.0 - 7.0 years
3 - 8 Lacs
Panvel, Navi Mumbai, Mumbai (All Areas)
Work from Office
The reputed pharmaceutical company engaged in development, manufacturing and marketing of oral solid dosages forms in regulated market. We are looking for competent, growth-oriented professional in Quality Assurance and Quality Control profiles for our USFDA & EU-GMP approved OSD manufacturing facility at Patalganga MIDC, Tal.- Panvel, Dist.- Raigad.Roles and Responsibilities Ensure compliance with cGMP guidelines during formulation development, solid oral manufacturing, and OSD production. Conduct analytical method validation, stability studies, and quality control activities to ensure product quality. Develop and maintain documentation for batch records, test results, and equipment calibra...
Posted 4 months ago
15.0 - 24.0 years
0 - 0 Lacs
Udaipur
Work from Office
Job Description: Head of Quality Experience: 15 Years or more Location: Udaipur About Macsen Drugs: Macsen Drugs is a USFDA registered, WHO-GMP certified, TGA GMP certified, and EU GMP (Written Confirmation) certified manufacturer of active pharmaceutical ingredients or bulk drugs for varied therapeutic applications like antidote, urinary antiseptic, topical antiseptic, ophthalmic diagnostic, anti-dandruff, anti-acne, and several other applications. Job Overview: We are seeking an experienced and detail-oriented individual to perform research activities as designing and conducting scientific experiments, analyzing and interpreting results, leading to significant value to the process developm...
Posted 4 months ago
7.0 - 12.0 years
6 - 16 Lacs
Hyderabad, Bengaluru
Work from Office
Position: Senior Medical Coder OVERVIEW Experienced Senior Medical Coder, specializing in MedDRA and WHODrug coding and Serious Adverse Event (SAE) Reconciliation. Proficient in navigating complex medical terminology, collaborating with cross-functional teams, and adhering to industry standards. Proven ability to contribute to the precision and consistency of coded data, ensuring patient safety and compliance with regulatory requirements. Adept at collaborating with cross-functional teams, implementing quality control measures, and contributing to the successful execution of clinical research. KEY TASKS & RESPONSIBILITIES Function as a Coding and SAE subject matter expert providing guidance ...
Posted 4 months ago
0.0 - 1.0 years
0 Lacs
Chennai
Work from Office
Role & responsibilities : Assist in the preparation, review, and submission of regulatory documents Help maintain regulatory files and records Support in compiling dossiers for product registrations and renewals Research regulatory requirements and updates from national/international authorities Coordinate with cross-functional teams for required data or documents Share your resume to hrd@stedmanpharma.com / 9786920463 Preferred candidate profile : This internship is ideal for students or recent graduates looking to gain hands-on experience in the field of Regulatory Affairs within the pharmaceutical industry. The intern will work closely with the RA team and assist with documentation, compl...
Posted 4 months ago
2.0 - 4.0 years
5 - 12 Lacs
Navi Mumbai
Work from Office
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 ac...
Posted 4 months ago
10.0 - 15.0 years
10 - 12 Lacs
Nagpur
Work from Office
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 depa...
Posted 4 months ago
2.0 - 7.0 years
3 - 8 Lacs
Hyderabad
Work from Office
Regulatory Affairs Job Opportunity! Desired Experience : 3- 15 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Manager/ Manager/ Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World Health Organization. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of...
Posted 5 months ago
5.0 - 8.0 years
5 - 10 Lacs
Navi Mumbai, Mumbai (All Areas)
Work from Office
KRA's: Quality check of all raw materials, in-process and finished goods on a FIFO basis QMS Implementation Audit Documentation Internal/ external as well as 3rd party/ regulatory audit compliances Required Candidate profile 5+ years of experience in Quality [quality inspection, auditing, testing, reporting] in a medical device/ pharmaceutical manufacturing co. Should be ready to travel or relocate to Taloja Navi Mumbai
Posted 5 months ago
10.0 - 15.0 years
8 - 12 Lacs
Mumbai, Thane, Navi Mumbai
Work from Office
QMS Implementation Audit facilitation: will represent the company during regulatory/ 3rd party audits: MHRA, USFDA, MCC, WHO, etc. Products: temperature-controlled packaging & temperature monitoring systems used for storage & transit of medicines Required Candidate profile Any science graduates 10-15 years' experience in quality, ideally in pharma/ medical devices/ equipment manufacturing industry International Audit Experience mandatory Should be open for global travel
Posted 5 months ago
5.0 - 10.0 years
6 - 9 Lacs
Hyderabad, Medchal
Work from Office
KRA's: Ensure SOPs are followed & quality standards are met Quality check of raw materials, in-process & finished goods on a FIFO basis QMS Implementation Audit Documentation Audit facilitation - Internal/ external & 3rd party/ regulatory audits Required Candidate profile 5+ years of experience in Quality [quality inspection, auditing, testing, reporting] in a pharma/ medical device mfg. co Ready to relocate to Medchal, Hyderabad Accommodation & food will be provided Perks and benefits Accommodation and Food provided
Posted 5 months ago
1.0 - 3.0 years
1 - 3 Lacs
Ahmedabad
Work from Office
Well known Denmark based pharma co Hiring QA Pharmacist Excellent communication skills 5 days working Pl share updated CV to careers5.righthire@gmail.com
Posted 5 months ago
10.0 - 15.0 years
10 - 15 Lacs
Navi Mumbai
Work from Office
Oversee the entire quality assurance process, from raw materials to finished goods, ensuring consistent quality & compliance, ensuring that products meet regulatory requirements & quality standards like ISO 13485, ISO 9001, 21 CFR 211 & 21 CFR 820 Required Candidate profile Bachelors in science 10-15 years' experience in quality in medical device/ pharma industry QMS implementation experience Must have regulatory audit exposure Like WHO/ USFDA & EU GMP
Posted 5 months ago
2.0 - 4.0 years
3 - 6 Lacs
Vellore
Work from Office
Applications are invited for the Project Associate-I for the MoES funded project under Deep Ocean Mission scheme in the School of Computer Science and Engineering (SCOPE), at Vellore Institute of Technology (VIT), (MoES/PAMC/DOM/58/2023 (E-14510) Title of the Project : Design and Development of Machine Learning Models and Expert System for Automated Characterization of Underwater Species: Indian Scenario Qualification : BE/B.Tech(CSE/IT/ECE/EEE) Describe if any Candidates who have knowledge in programming, app development, image processing, full stack development, machine learning, deep learning and computer related field will be given preference Stipend : Rs. 31,000/- per month + HRA (as pe...
Posted 5 months ago
2.0 - 4.0 years
4 - 7 Lacs
Vellore
Work from Office
Applications are invited for the Senior Project Associate for the MoES funded project under Deep Ocean Mission scheme in the School of Computer Science and Engineering (SCOPE), at Vellore Institute of Technology (VIT), (MoES/PAMC/DOM/58/2023 (E-14510) Title of the Project : Design and Development of Machine Learning Models and Expert System for Automated Characterization of Underwater Species: Indian Scenario Qualification : BE/B.Tech(CSE/IT/ECE/EEE) with Four years’ experience in Research and Development in Industry and Academic Institutions or Science and Technology Organizations and Scientific activities and Services OR Doctoral Degree in Engineering/Technology/MS from a recognized Univer...
Posted 5 months ago
20.0 - 25.0 years
10 - 20 Lacs
Ahmedabad, Gurugram
Work from Office
Guide the upgrade and development of plant infrastructure and systems to meet the requirements of: WHO-GMP, Russia, Australia/New Zealand, and African regulatory authorities, Ultimately UKMHRA and USFDA. Provide expert support on: WHO-GMP and GLP.
Posted 5 months ago
20.0 - 30.0 years
20 - 30 Lacs
Ahmedabad
Work from Office
Job Title: FDA & International Pharma Compliance Consultant (Excipients, API & Ingredients & Formulations) Location: Kutch, Gujarat (Remote advisory with periodic on-site presence) Experience: 2025 years in pharmaceutical manufacturing and regulatory compliance Salary: Competitive Education: Bachelors or Master’s in Pharmacy, Pharmaceutical Sciences, Chemistry or related discipline Kindly get in touch for career advancement opportunities with us at rupsha.saha@antal.com Roles & Responsibilities Guide the upgrade and development of plant infrastructure and systems to achieve compliance with: WHO-GMP Regulatory requirements of Russia, Australia/New Zealand, African authorities Ultimate readine...
Posted 5 months ago
3.0 - 8.0 years
5 - 11 Lacs
Hyderabad
Work from Office
Desired Experience : 3-7 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Main purpose of the Job: Responsible for Preparation of Regulatory Documents for submission to Indian NRA, WHO and other Regulatory Authorities. Job Responsibilities: 1. Preparation of following Regulatory Submission Packages related to NRA submissions but not limited to. a. Application for Post Approval Change(s) b. Marketing Authorization Applications c. Clinical trial applications d. Support the submission of Import licenses/ export NoC e. Support...
Posted 5 months ago
15 - 20 years
8 - 10 Lacs
Himachal Pradesh
Work from Office
Roles and Responsibilities Ensure compliance with GMP guidelines, BMRs, OSD requirements, and WHO standards for IPQA activities. Develop and implement effective quality control processes to ensure product quality and regulatory compliance. Conduct regular audits, inspections, and investigations to identify areas of improvement in batch manufacturing operations. Collaborate with cross-functional teams to resolve quality issues related to formulations, tablets, capsules, etc. Provide training on Good Manufacturing Practices (GMP) and other relevant regulations to employees.
Posted 5 months ago
8 - 10 years
12 - 15 Lacs
Hyderabad
Work from Office
Job title manager GMP (Good Manufacturing Practices) QA (Quality Assurance) Reports to Head of Quality Assurance (GMP and GCP) Job purpose Our Quality team is growing, and we are currently seeking a Manager of GMP QA Operations to play a pivotal role in ensuring the quality and compliance of our clinical and commercial manufacturing processes. Reporting to the Head of QA, the Manager will oversee a team responsible for manufacturing, batch record release, investigations, deviations, CAPAs (Corrective and Preventive Actions), change controls, analytical methods, stability programs, and auditing within our GMP operations. Duties and responsibilities QA managers define and implement quality sta...
Posted 5 months ago
4 - 9 years
30 - 32 Lacs
Bengaluru
Work from Office
About The Role : Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Se...
Posted 5 months ago
5 - 10 years
0 - 0 Lacs
Noida, Bhiwadi
Work from Office
Roles and Responsibilities Ensure compliance with regulatory requirements from USFDA, GMP, WHO, and other relevant authorities. Conduct internal audits to identify areas of improvement and implement corrective actions. Develop and maintain relationships with regulatory agencies to ensure smooth operations. Provide guidance on Good Manufacturing Practices (GMP) and Current Good Manufacturing Practice (cGMP) guidelines. Collaborate with cross-functional teams to resolve regulatory issues. Desired Candidate Profile 5-10 years of experience in Regulatory Affairs or related field. Strong knowledge of Allopathy or homeopathy regulations and guidelines. Proven track record of handling regulatory au...
Posted 5 months ago
15 - 20 years
13 - 17 Lacs
Mumbai, Boisar, Palghar
Work from Office
Role & responsibilities 1. Production Planning and Scheduling 2. Compliance and Documentation 3. Supervision of Manufacturing Processes 4. Personnel Management and Training 5. Quality and In-Process Control 7. Process Optimization and Yield Improvement 8. Regulatory and Customer Audits Preferred candidate profile Education: B.Pharm / M.Pharm / B.Sc with strong domain knowledge in OSD manufacturing. Experience: 15+ years in pharmaceutical production, with at least 5 years in a managerial role overseeing OSD manufacturing. Regulatory Exposure: Hands-on experience in facing WHO-GMP, and other inspections. Skills: Leadership, decision-making, analytical thinking, team management, and strong know...
Posted 5 months ago
1 - 5 years
3 - 7 Lacs
Pune
Work from Office
About The Role Job TitleSA LocationMumbai / Pune Skill- End to end KYC, Periodic Review, AML, and Due Diligence Shift Timings:APAC , EMEA , NAM Roles & Responsibilities This role will include the understanding and implementation of the KYC lifecycle. He/she would be responsible for opening, amending, reviewing and exiting clients according to established policies and procedures, and also review clients transactions to detect and report either proposed or completed unusual transactions. Key responsibilities include: Performing the due diligence on new Clients, requesting the KYC information, documentation, review and verification of received documentation and making an analytical risk assessm...
Posted 5 months ago
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