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0.0 - 3.0 years
1 - 4 Lacs
Gangtok
Work from Office
Division Department Sub Department 1 Job Purpose Perform sampling, execute and document the analysis of raw materials, packing materials, products assigned for testing and complete all the stability studies in order to ensure its compliance to the laid down quality parameters and predefined specifications / standards and meet SRB targets Key Accountabilities (1/6) Analyse the assigned samples and chromatographic tests for analysis by using the suitable valid procedure and calibrated instruments to ensure the compliance to the set specification / standards Perform analysis for release of RM, PM, FP water analysis and process/cleaning validation as per commitment dates Perform analysis for sta...
Posted 3 months ago
1.0 - 4.0 years
9 - 13 Lacs
Mumbai
Work from Office
Cost & Productivity Reinvention (Direct Spend) Find endless opportunities to solve our clients' toughestchallenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Strategy & Consulting, Global Network I Areas of Work: Cost takeout, earnings before interest, taxes, depreciation, and amortization, (EBITDA) improvement in Direct Spend | Level:Consultant | Location: Delhi, Gurgaon, Mumbai, Bangalore, Pune, Hyderabad| Years of Exp:4-8 years for Consultant, 1-4 years for Analyst Explore an Exciting Career at Accenture Are you an outcome-oriented problem solverDo you enjoy working on transformation strategies for global clientsDoes working in...
Posted 3 months ago
2.0 - 5.0 years
3 - 7 Lacs
Sanand
Work from Office
Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary May assure compliance to i...
Posted 3 months ago
0.0 - 2.0 years
4 - 8 Lacs
Ahmedabad
Work from Office
Need to have good understanding of the D & C Act, CDSCO Guidance for Industry, ICH Regulations and NDPS Acts. - Strategize, submit and Obtain approvals from CDSCO i.e. FORM 11, CT 17, CT 04, CT 21, CT 18, Form 10, MD 5, MD 6, MD 17, MD 15, Dual NOC in timely manner. - Strategize, submit and obtain approvals from State FDA i.e. Test license, Manufacturing license, Export/Domestic License, COPP, FSC, Loan License, WHO GMP, State GMP/GLP. - Strategize, submit and obtain approvals from CBN i.e. Export Authorizations and Import Authorizations. - Additionally, must have knowledge about FSSAI registration and licenses. - Ensure that regulatory strategies are implemented, timely review and alignment...
Posted 3 months ago
1.0 - 9.0 years
4 - 8 Lacs
Hyderabad
Work from Office
Career Category Operations 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 ...
Posted 3 months ago
1.0 - 6.0 years
1 - 5 Lacs
Chennai
Work from Office
Stedman Pharmaceuticals is looking for a dynamic and experienced candidate for the Quality Control (QC) department with hands-on experience in Analytical Method Validation for various dosage forms. Resume to hrd@stedmanpharma.com / 9786920463
Posted 3 months ago
3.0 - 4.0 years
3 - 4 Lacs
Bilaspur, Uttar Pradesh, Uttar Pradesh, India
On-site
Responsible for conducting the qualification of microbiology lab To conduct environmental monitoring, water sampling and testing, product testing and other microbial analysis as per monograph and SOPs Responsible to follow of quality management system documents Raising the purchase requisition for arranging the items related to microbiology To execute the protocol and report to perform the validation/study activities To perform the calibration and verification of microbiological instruments Perform the trend and summary report Follow GMP and GLP and maintain the compliance in microbiology lab the site safety procedure To perform the analysis of API and final products based on the requirement...
Posted 3 months ago
5.0 - 10.0 years
5 - 10 Lacs
Bilaspur, Uttar Pradesh, Uttar Pradesh, India
On-site
24 7 audit readiness Exposure in Wet Chemistry & responsible to works in different shifts Perform the raw material analysis & wet lab activity by using the technique (KF, pH, KFC, UV, FTIR, SOR, Oven, Auto titrator, Polari meter & TLC) etc. Sampling of Raw material / FG / intermediates / cleaning samples based on requirement and result entry in analytical sheet, QA form, LIMS and online documentation as per data integrity norms Perform analytical test according to the monograph and SOP & follow up the housekeeping, cGMP, GLP and Safety Guideline in laboratory Participation in internal, external, regulatory audits & Ensure 100% participation in training s against CAPA s Responsible for initia...
Posted 3 months ago
2.0 - 5.0 years
0 Lacs
Pune, Maharashtra, India
On-site
Overview Job Overview: 1.??Ensuring best quality of product and minimum customer complaints through stringent on-line quality control checks and finished product inspection 2.??Implementing right quality control systems/standards for the processes, physical systems and environment. 3.??Trouble shooting during online production to minimize wastage and ensure quality. 4.??Responsible for maintaining GMP, GHK GLP and internal / external audits (HACCP, AIB, Personal Hygiene, Process audit) 5.??Root cause and failure analysis for quality defects and implementation of the corrective actions. Responsibilities Responsibilities: Conducting online quality checks in the process area to ensure that all ...
Posted 3 months ago
0.0 - 3.0 years
1 - 4 Lacs
Shimla
Work from Office
Division Department Sub Department 1 Job Purpose Perform sampling, execute and document the analysis of raw materials, packing materials, products assigned for testing and complete all the stability studies in order to ensure its compliance to the laid down quality parameters and predefined specifications / standards and meet SRB targets Key Accountabilities (1/6) Analyse the assigned samples and chromatographic tests for analysis by using the suitable valid procedure and calibrated instruments to ensure the compliance to the set specification / standards Perform analysis for release of RM, PM, FP & water analysis and process/cleaning validation as per commitment dates Perform analysis for s...
Posted 3 months ago
5.0 - 10.0 years
10 - 15 Lacs
Hyderabad
Work from Office
Job purpose: As part of the Ocugen team, the GxP Systems Specialist will implement and manage the Ocugen Veeva vault and other GxP applications to meet regulatory requirements and business needs. The ideal candidate should bring experience working in enterprise application environments in life sciences with the ability to manage multiple projects across different functions. The candidate should also be experienced as a technical lead for IT (Information Technology) projects. Duties and responsibilities: Accountable for implementation/delivery of Veeva applications to meet Ocugen business needs with a focus on regulated functions: Serve as a subject matter expert in business and system admini...
Posted 3 months ago
5.0 - 10.0 years
10 - 15 Lacs
Hyderabad
Work from Office
Job purpose: As part of the Ocugen team, the GxP Systems Specialist will implement and manage the Ocugen Veeva vault and other GxP applications to meet regulatory requirements and business needs. The ideal candidate should bring experience working in enterprise application environments in life sciences with the ability to manage multiple projects across different functions. The candidate should also be experienced as a technical lead for IT (Information Technology) projects. Duties and responsibilities: Accountable for implementation/delivery of Veeva applications to meet Ocugen business needs with a focus on regulated functions: Serve as a subject matter expert in business and system admini...
Posted 3 months ago
4.0 - 6.0 years
6 - 8 Lacs
Hyderabad
Work from Office
What you will do In this vital role you will work closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role leverages scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a m...
Posted 3 months ago
1.0 - 3.0 years
3 - 5 Lacs
Rangareddy, Hyderabad
Work from Office
Dear Candidate , we are hiring for the Position Jr Executive .(Instrumentation,Hematology,Activity,Potency Based Assays,Bio chemical group) 1.Candidate have good hands on experience in HPLC, electroscopic test methods. 2.should be able to handle liquid chromatography instrument and relevant 21 CFR softwares 3.should be able to handle ELISA Reader ,microscope,basic QC Instruments . 4.candidate should have good hands experience in colorimetric ,spectrophotometric. 5. should be have a idea on GLP compliance requirements. for more details please reach out Venkat -9381915043 /Manasa - 9502434725
Posted 3 months ago
4.0 - 8.0 years
6 - 10 Lacs
Medak
Work from Office
Business: PPL Digwal Department: PTS Location: Digwal Job Overview: To perform ARD actives as per GMP Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - ARD (Service) Key Stakeholders: Internal: QC, QA, SCM Safety External: NA Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability...
Posted 3 months ago
10.0 - 16.0 years
10 - 20 Lacs
Jadcherla
Work from Office
Role & responsibilities Analytical data review of in-process, Batch release and stability samples & planning of activities in the Instrumentation lab Trouble shooting of HPLC & UPLC instruments, maintaining of lab as per GLP GDP practices. Audit trail verification of APLE & UPLC 1. Preparation, revision and review of SOPs, STPs, Specifications and GTPs and Worksheets related to product testing. 2. Preparation, revision and review of analytical method Validation protocols and reports related to product testing. 3. Responsible for shift schedules and test planning activities. 4. Testing, documentation, review and release of In-process, Batch release, Stability and Miscellaneous samples. 5. Res...
Posted 3 months ago
7.0 - 12.0 years
9 - 14 Lacs
Hyderabad
Work from Office
What you will do In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for quali...
Posted 3 months ago
10.0 - 15.0 years
15 - 28 Lacs
Remote, , India
On-site
Bachelor's degree with over 10 years of experience in designing and developing solutions in Trackwise. Experience working in a GMP environment, 7+ years in an IT Systems Role. Expert knowledge of GMP Quality Management to include CAPA/Deviation, Lab Exception, Product Complaint, Audit, and Supplier Management. SDLC/GAMP, Business Analysis, and Enterprise Systems Management. General knowledge of GxP Quality Processes and Systems (GMP, GLP, GCP, GVP, GDP) Demonstrated experience leading teams in the implementation of Trackwise and QMS solutions, ensuring alignment with business objectives and compliance requirements. Comprehensive understanding of Quality Management processes, regulatory compl...
Posted 3 months ago
2.0 - 7.0 years
4 - 8 Lacs
Mysuru
Work from Office
Vibonum Technologies Private Limted conducting a Walk-in interview in Hyderabad for Quality Control Executives and Officers for its OSD Plant at Mysore. Date of Walk-in: 14th & 15th Jun 2025 Responsibilities Hands-on experience on QC instruments such as HPLC, GC, UV-Vis Spectrophotometer, FTIR, Dissolution Tester, TOC Analyzer, etc. Exposure to stability testing, raw material and finished product, In-process and stability analysis, documentation as per cGMP, and regulatory compliance (WHO, USFDA, MHRA, etc.) Analytical data review and QMS Knowledge of Good Laboratory Practices and analytical method validation/verification is preferred. Quality Control Executive Total Vacancies - 20, Educatio...
Posted 3 months ago
2.0 - 7.0 years
3 - 8 Lacs
Ahmedabad
Work from Office
Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities 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 ...
Posted 3 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 3 months ago
1.0 - 6.0 years
1 - 6 Lacs
Tirupati, Chennai, Bengaluru
Work from Office
Role & responsibilities Aurobindo Pharma Ltd. Unit IV (Naidupeta, Tirupati Dist., Andhra Pradesh) Open Functions: Quality Assurance (Market Complaints / QMS / Validation / IPQA) Quality Control (GMP / GC / LCMS / HPLC) 3 Experience Required: 2 7 years (pharmaceutical manufacturing) Job Titles & Grades: Executive / Sr. Executive (based on experience) Job Description: Quality Assurance Key Scope • Handle Market Complaint investigations, trend analysis and regulatory responses • Maintain site QMS: Deviations, CAPA, Change Control, Audit readiness • Execute and review Equipment / Process / Cleaning Validation documentation • Perform IPQA activities: line clearance, in-process checks, batch recor...
Posted 3 months ago
2.0 - 3.0 years
3 - 3 Lacs
Hyderabad
Work from Office
Retrival& Issuance of documentation GDP CGMP Control Documents Dispatch verification Batch Manufacturing
Posted 3 months ago
15.0 - 20.0 years
20 - 25 Lacs
Gangtok
Work from Office
Division Department Sub Department 1 Job Purpose Overseeing all aspects of Microbiology (Sterile and Non-sterile) at site. Responsibility for maintaining & monitoring cGMP Compliance by ensuring applicable systems, processes and procedures are in place. Keeps informed of existing and proposed FDA regulation relating to assigned responsibility, appraised their effect on company operation and sees that appropriated action is taken to assure compliance with FDA regulator and compliances for various regulatory agencies. Ensuring closure, investigation for investigation of out of specification / out of trend (OOAC &OOAL), complaints, deviation and batch failures (including stability) are appropri...
Posted 3 months ago
4.0 - 7.0 years
13 - 18 Lacs
Hyderabad
Work from Office
Summary 400! This is the number of associates in Global Analytical R&D, across 4 countries, working tirelessly on innovative and patient centric medicines. As part of this group, you design, plan and/or perform scientific/technical studies. By bridging the analytical science to the clinical performance you will drive the transformation of our molecules into medicines that improve and extend patient s lives. About the Role Major Accountabilities: Design, plan and perform scientific experiments for projects at different clinical phases of drug substance and drug product with minimal guidance. Monitors degradation pathways and shelf-life of products. Well versed with regulatory guidelines, scie...
Posted 3 months ago
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