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4.0 - 12.0 years

4 - 12 Lacs

Hyderabad, Telangana, India

Remote

What you will do The Quality Compliance Manager is a global role and part of the Process Quality team for the RD Quality Organization. In this vital role you will work with a team of process-focused colleagues who work to complete Amgen s Process Quality strategy, which is vital to ensuring that Amgen s Research and Development Standards (SOPs and associated documentation) are adequate, clear, and up to all applicable current regulations and quality requirements. The RD Process Quality team supports the Quality Management System (QMS) across all areas of research at Amgen, including discovery through the full clinical development lifecycle. This team ensures that all Amgen s business procedu...

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15.0 - 24.0 years

14 - 19 Lacs

Dahej

Work from Office

Leading the Quality Control Teamaccording to the norms of GMP (Good Manufacturing Practices) to ensure international quality standards and adherence to various regulatory requirements. Developing and reviewing cGMP compliance related documents like global procedures, methods, standards, specification, validation protocols, summary reports. Implementation of management system for Change control, CAPA, OOS, Risk analysis, deviation management system, incidents (Lab ware LIMS, eQMS,Track wise) and complaint management system. Actively participated in QTA between CMO and receiving/transferring site. Review and approval of APQR. Root cause analysis/ Failure investigation and corrective and preven...

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2.0 - 7.0 years

2 - 6 Lacs

Bhiwadi

Work from Office

Opening in Medicamen Biotech Ltd(ANVISA & EU), Bhiwadi, Raj. Pharma formulation exp. Preferred Qualification: B.Sc./B.Pharma Vacant Post: 10 Nos. QA - IPQA/Documentation/Validation QC - IPQC/HPLC/Chemical Testing/GC/KF Mail-ID: hrd@medicamen.com Required Candidate profile Immediate joiner prefer Experience : 2 to 6 Years Ready to Relocate Bhiwadi Self Motivated/ Team Player/ Committed for Performance. E-Mail: hr-ho@medicamen.com Mob: +91 7240001632/ 9992395009

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0.0 - 1.0 years

2 - 2 Lacs

Ludhiana

Work from Office

Freshers can also welcomed for interview. QC Executive To monitor all process steps (physical, chemical & microbiological testing) and control points as per defined parameters and standards. To monitor effectiveness of overall cleaning and sanitation of the plant including all warehouses. To monitor GLP practices in lab, resources needed as per laboratory requirement. To monitor the product quality through compliance of specification for raw material, packaging material & finished products. To monitor testing plan, calendar & standard for inside & outside testing & to ensure outside testing as per schedule. To check and verify the daily deviation report, taking appropriate actions against th...

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4.0 - 7.0 years

4 - 5 Lacs

Faridabad

Work from Office

Role & responsibilities Inventory Management: Maintain accurate records of all bulk packaging materials (e.g., bottles, blisters, foils, labels, cartons, etc.). Ensure proper stocking levels and avoid stock-outs or overstocking. Material Receipt & Inspection: Oversee receiving activities of packaging materials. Ensure materials are received as per purchase orders and conduct visual and quantitative inspection in coordination with Quality Assurance (QA). Storage Compliance: Store packaging materials under specified storage conditions. Ensure cleanliness, segregation, and proper labeling as per GMP and SOPs. Material Issuance: Issue materials to production as per batch manufacturing records (B...

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3.0 - 8.0 years

4 - 9 Lacs

Chandigarh

Work from Office

Role & responsibilities Responsible for compliance as per 9001:2015, ISO 14001:2015, ISO 45001:2018. Responsible for validation/ verification of Analytical Methods on ICP-MS, AAS, HPLC and instruments as per ICH Q2 (R2). Responsible for development of Cost-effective, rugged and robust analytical methods on ICP-MS, AAS, HPLC, and wet lab instruments as per ICH Q14 and Analytical QbD. To maintain GLP compliance as per OECD or other regulatory/ general guidelines in ARD lab. Responsible for performing technology transfer of analytical method in QC(Plant). Any other responsibility assign by ARD head, time to time on need basis. Preferred candidate profile Post graduate (M.Pharma/M.Sc) Must be fr...

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4.0 - 8.0 years

3 - 7 Lacs

Akola

Work from Office

Role & responsibilities a. Perform routine testing of raw materials, in-process, and finished products as per approved methods. b. Operate analytical instruments like HPLC, GC, UV, FTIR, and dissolution apparatus. c. Maintain and document all test results accurately in compliance with cGMP and GLP guidelines. d. Support stability studies, method validation, and method transfer under supervision. e. Assist in investigation of OOS/OOT results and follow SOPs strictly. f. Ensure proper calibration and maintenance of laboratory instruments. g. Maintain lab safety, cleanliness, and participate in regular training programs. h. Coordinate with other team members to ensure timely completion of lab a...

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2.0 - 5.0 years

3 - 4 Lacs

Hyderabad

Work from Office

Role & responsibilities- Conduct analysis of samples using HPLC, GC, Spectrometer, and other basic analytical instruments of the lab with experience in developing and validating HPLC/GC methods Analysis of Sugars, Alcohols, Antibiotics, enzymes, active ingredients, and raw material using HPLC/GC Providing Technical support for internal and external stake holders Being the clear R&D player by working closely with cross-functional teams to drive execution across multiple projects while maintaining and achieving timelines to ensure speed to market. To conduct analysis of samples and provide inputs to R&D/QC teams Required Skill Sets: Hands on experience on HPLC, GC, Spectrometer, and other basi...

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1.0 - 6.0 years

0 - 3 Lacs

Hyderabad

Work from Office

Company Description ProvenTech Consulting Pvt Ltd is a global digital native company with a focus on Lifesciences & Healthcare domains. Their commitment is to offer Services and products for the pharma industry through constant development, implementation and support. ProvenTech facilitate businesses to transform them into future-ready laboratories through pharma-4.0 state-of-the-art technology. Role Description We are seeking a highly motivated and detail-oriented individual to join our team as a LIMS Master Data Creation Specialist. In this role, you will be responsible for the accurate and timely creation and maintenance of master data within our LIMS platform. The successful candidate wi...

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4.0 - 8.0 years

3 - 6 Lacs

Bharuch, Ahmedabad, Vadodara

Work from Office

To ensure the implementation of Good Laboratory Practice and Good Documentation Practice in Quality Control. Analysis of In-process, finished products, stability samples of various formulation products: oral solids, Topical, cosmetics. Responsible for investigation and initiation of change control, Laboratory incidents, CAPA, OOS, OOT. To Co-ordinate with Quality control Manager to prepared the Analytical Method Validation protocol and Report. To perform the analytical method validation as per requirmnet. To ensure the implementation of Good Laboratory Practice and Good Documentation Practice in Quality Control Also having sound knowledge about data integrity, ALCOA principals and respective...

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5.0 - 10.0 years

3 - 4 Lacs

Vikarabad, Tandur, Hyderabad

Work from Office

Hello Candidate, Greetings from Hungry Bird IT Consulting Services Pvt. Ltd.! We're hiring a Quality Control Head for our client. Qualification: MSc in Chemistry, Biochemistry, or a related field Location: Vikarabad District, Telangana Experience: 5 to 8 Years Salary: 3.5 lakhs to 4 lakhs per annum Required: Male Note: Preferably with strong experience in the pharmaceutical or ethanol industry. Job Summary: We are seeking an experienced Quality Control Head to lead the QC team at our client's facility. The ideal candidate will have a strong background in analytical techniques, including Gas Chromatography (GC) and High-Performance Liquid Chromatography (HPLC), and will be responsible for ens...

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3.0 - 5.0 years

3 - 7 Lacs

Dahanu

Work from Office

Job Objective: Plan, allocate and review testing for the release of all RM, processed material, finished products to achieve the committed lead time for Production and for achieving targeted OTDIF Maintain microbiological laboratory GLP compliant as per Schedule L of Drug and cosmetic act. Ensure implementation and sustain of safe environment in microbiology laboratory. SOP review & availability of current version Roles and Responsibilities: Daily review of testing of FP, RM, Water, Air, In-process & Swab as per given procedure and frequency. Daily work allocation to microbiologists. Daily review of records and logbooks maintained in microbiology laboratory. Daily communication to operation ...

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7.0 - 11.0 years

7 - 8 Lacs

Ahmedabad

Work from Office

Job Description Version. no.: The Job Responsibilities of the position holder are : Responsible for performing the analytical activities as per Analytical competency matrix (Format No.BDI-QCSG004F23) and On job training and Practical Demonstration for Chemical and Instrumentation (Format No.BDI-QCSG004F19). Analysis of In process, SFG, Finished Goods, Raw material & stability sample, Analytical method validation/Verification, of OSD and LVP as per defined Protocol or procedure and related documentation as per GLP and GMP in time. Responsible for receiving sample and their documentation. Responsible Data entry in SAP. Responsible for sending the sample to outside laboratory and ensure their a...

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2.0 - 3.0 years

4 - 5 Lacs

Chandrapur

Work from Office

Dalmia Bharat Group is looking for Shift Chemist to join our dynamic team and embark on a rewarding career journey Chemical Process Monitoring: Monitoring chemical processes, reactions, and operations to ensure they are running smoothly and in accordance with established procedures Quality Control: Conducting quality control tests and inspections on raw materials, intermediate products, and finished products to ensure they meet specified standards and regulations Sample Analysis: Collecting and analyzing samples of chemicals, compounds, or products using various analytical techniques and instruments, such as spectroscopy, chromatography, and titration Data Interpretation: Interpreting analyt...

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1.0 - 6.0 years

3 - 8 Lacs

Chandrapur

Work from Office

Dalmia Cement Bharat Ltd is looking for Shift Chemist to join our dynamic team and embark on a rewarding career journey Chemical Process Monitoring: Monitoring chemical processes, reactions, and operations to ensure they are running smoothly and in accordance with established procedures Quality Control: Conducting quality control tests and inspections on raw materials, intermediate products, and finished products to ensure they meet specified standards and regulations Sample Analysis: Collecting and analyzing samples of chemicals, compounds, or products using various analytical techniques and instruments, such as spectroscopy, chromatography, and titration Data Interpretation: Interpreting a...

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1.0 - 9.0 years

6 - 7 Lacs

Ahmedabad

Work from Office

Prepare trending of Events/Incident and ensure completeness of its closure. Identify the gaps and provide appropriate training to analytical scientist to strengthen compliance level. Thorough review of clinical batch release data, method validation protocol & report, clinical stability sample analysis, as per cGMP and regulatory requirement. Ensure review of daily verification/calibration of pH meter, balances and TOC. Ensure review of calibration record of all analytical instruments and update of calibration planner in timely manner. Thorough review of method development report and investigation study report Randomly review and cross verify all analytical instrument logbook entries and labo...

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8.0 - 12.0 years

7 - 10 Lacs

Baddi

Work from Office

Role & responsibilities :- Perform and approve Sterility Testing using direct inoculation or membrane filtration methods as per pharmacopeial standards (USP, EP, IP, JP). Supervise aseptic testing procedures in ISO Class 5 (Grade A) environments within validated sterility testing isolators or LAFs . Ensure environmental monitoring , personnel monitoring , and media fill (ASEPTIC Process Simulation) activities are conducted and reviewed as per schedule. Approve microbiological testing results, including bioburden , endotoxin , water testing , and identification of microorganisms . Conduct investigations of microbiological OOS/OOT results and deviations , and support implementation of correcti...

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3.0 - 6.0 years

6 - 10 Lacs

Mumbai

Work from Office

Division Department Sub Department 1 Job Purpose Develop, optimise and execute the process for APIs to ensure on time implementation within budget Key Accountabilities (1/6) Develop API process in lab by literature survey, API intermediate characterization to ensure the quality and on time implementation Carry out literature survey and route selection for assigned project Prepare and execute development strategy for the assigned project Maintain record book of experiments carried out in lab, results received from the ADL Optimize process parameters to achieve process robustness for ensuring successful completion of lab trial and lab confirmatory batches with optimised costs Support creation ...

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3.0 - 4.0 years

2 - 3 Lacs

Mumbai

Work from Office

Sodexo Food Solutions India Pvt. Ltd.ces is looking for MIS Admin Assistant to join our dynamic team and embark on a rewarding career journey Oversee the design, implementation, and maintenance of the information systems, including hardware, software, and networking infrastructure Manage the database systems, including data backup and recovery, data security, and data integrity Develop and maintain procedures for managing the information systems and technology infrastructure, including disaster recovery plans, security policies, and user access controls Analyze the business processes and identify opportunities for improvement through the use of information systems and technology Collaborate ...

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4.0 - 7.0 years

4 - 8 Lacs

Visakhapatnam

Work from Office

We are seeking a meticulous and experienced Executive/Sr. Executive to spearhead chromatographic analysis and data review at Synnat Pharma Private Limited, a rapidly growing API manufacturer. In this pivotal role, you will be responsible for ensuring the accuracy, reliability, and compliance of analytical data generated within our QC laboratory. Your expertise will be crucial in adhering to stringent regulatory standards, including ICH guidelines and pharmacopeial requirements, while contributing to the overall quality and integrity of our pharmaceutical products. The ideal candidate will possess a strong understanding of HPLC and GC systems, coupled with proficiency in Empower CDS and a dee...

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3.0 - 8.0 years

4 - 8 Lacs

Hyderabad

Work from Office

FERRING THERAPEUTICS PRIVATE LIMITED is looking for Analyst QC to join our dynamic team and embark on a rewarding career journey Analyze data, interpret trends, prepare reports, and support decision-making through insights Develop models, work with tools like Excel, SQL, or Python Ensure data accuracy, and contribute to business optimization and forecasting efforts

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12.0 - 17.0 years

11 - 17 Lacs

Ahmedabad

Work from Office

Role & responsibilities Lead and manage the Quality Control team to ensure timely and accurate analysis of finished products (OSD & Injectables). Review and approve analytical reports, ensure compliance with GLP and cGMP standards. Oversee operations involving HPLC, GC, UV, IR , and other sophisticated instruments. Ensure proper implementation of MPCL and maintain all microbiological standards in compliance with regulatory guidelines. Handle all regulatory audits (USFDA, MHRA, WHO, etc.) and prepare necessary documentation. Manage OOS/OOT investigations and ensure CAPA implementation. Coordinate with cross-functional teams (QA, production, regulatory affairs) to ensure product quality. Train...

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2.0 - 4.0 years

3 - 6 Lacs

Bengaluru

Work from Office

Job Summary: Perform and report the analysis of In-Process samples, finished products, Stability samples and Cleaning Validation. Job Responsibilities: To ensure timely completion of analysis and data completion for the same. To be responsible for all activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality systems. To perform the in-process/finish product/stability testing of laboratory Batches, Commercial batches, other stability samples and Cleaning validation. To Prepare Stability Trend Reports for Laboratory samples. To collect and maintain various laboratory samples. To generate and maintain records related to laboratory sam...

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3.0 - 6.0 years

3 - 6 Lacs

Bengaluru / Bangalore, Karnataka, India

On-site

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Rev...

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3.0 - 6.0 years

3 - 6 Lacs

Bengaluru / Bangalore, Karnataka, India

On-site

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. Position Summary: Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations Essential Duties and Resp...

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