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3.0 - 8.0 years
5 - 15 Lacs
Bharuch
Work from Office
Position Assistant Manager - Quality Control Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;;; Reports to QC Head; Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Regularize the QC activities as per cGMP requirements. Regulatory and Pharmacopeia requirement for lab compliance. Review of hybrid and electronic data for IPQC and FG analysis.; Analytical method validation, OOS and OOT.; Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP. Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Co-ordination with QC staff, R and D, Commercial and production for quality and dispatch related activities for on time dispatches. Resolve the trouble shooting related to QC activities.; Training to subordinate and employment of 21 CFR Part 211, 111 with data integrity (Part-11) compliance in lab. Awareness about responsible care (Environment, Health, Safety and Security) No. of Reportees 2-3 numbers Qualification and Experience M.Sc. (Chemistry) with 8-12 yrs. y Competencies; (Technical, Functional and Behavioral) Responsible for implementation and compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP. Hand-on experience as Reviewer of electronic data and hybrid system in regulatory environment (US-FDA, WHO etc.) Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11)
Posted 3 weeks ago
2.0 - 7.0 years
4 - 8 Lacs
Mysuru
Work from Office
Vibonum Technologies Private Limted conducting a Walk-in interview for Quality Control Executives and Officers Production for its OSD Plant at Mysore. Quality Control Executive Total Vacancies - 20, Education: B. Pharm / M. Pharm / M.Sc Exp: 6-8 Years Quality Control Officer Total Vacancies - 20, Education: B. Pharm / M. Pharm / M.Sc Exp: 2-5 Years Work Location: Nanjangud Mysore Walking Address: Sai Vishram Business Hotel, Hebbagodi, 144-C/1, Kirloskar Road, opp. MTR, Bommasandra Industrial Area, Bommasandra, Bengaluru, Karnataka 560099 Google Map: https://maps.app.goo.gl/Pkh8ASL1JFpJv2An8
Posted 3 weeks ago
15.0 - 20.0 years
20 - 25 Lacs
Nanjangud, Mysuru
Work from Office
Key Responsibilities: Oversight of Quality Control activities related to Raw Materials and Packing Materials . Supervision & review of analytical data, documentation & compliance for material release. Handling of Quality Management System (QMS) elements including OOS, OOT, deviations, CAPA, and change controls . Coordination with cross-functional teams for timely review and resolution of quality issues. Ensuring regulatory compliance as per current GMP standards. Leading audits, facing regulatory inspections, and supporting continual improvement initiatives. Candidate Profile: B. Pharm / M. Pharm / M.Sc. with 15 - 20 years of relevant experience in the pharmaceutical industry. Strong exposure to quality control of raw and packing materials in regulated environments. Hands-on experience in QMS implementation and review processes . Excellent documentation, communication, and leadership skills. Must be willing to relocate to Mysore, Karnataka .
Posted 3 weeks ago
years
4 - 7 Lacs
Bengaluru
Work from Office
About the Role We are currently seeking a data-driven and detail-oriented Program Intern to join the Founder’s Office. This role will involve critical thinking, problem-solving, and analytical thinking to drive operational improvements and support strategic initiatives. The charter for this role will include Work closely with the founder/senior leaders to turn ideas into validated experiments. Dive into industry trends, discover competitor insights while also working on user research. Build a hypothesis to solve the different problem statements, execute, validate and scale the results Align with stakeholders across the org to drive the actionables; be a driving force in cross-functional teams Present findings, recommendations, and progress updates to leadership. Support key projects and initiatives, ensuring they are on track and aligned with the company's objectives Ideal Persona would Prior experience in building a start-up or interning at a start-up. Good communication and presentation skills, both written and verbal. Ability to work collaboratively and effectively with diverse teams and stakeholders. High on agency with first principle problem-solving approach Familiarity with analytical tools like Excel (advanced), SQL, Python, or other business intelligence software is a plus. Strong organizational skills and ability to manage multiple tasks simultaneously. A proactive mindset with a strong ability to identify potential problems and come up with creative solutions.
Posted 1 month ago
1 - 3 years
2 - 3 Lacs
Hyderabad
Work from Office
Job Title: Junior Analyst / Analyst Experience: 1 to 3 years Location: Hyderabad CTC: 2.5 3.5 LPA Qualification: M.Sc. in Chemistry / Analytical Chemistry Preferred profile: from a food testing laboratory background Job Description: We are seeking a dedicated and skilled chemist with 1 to 3 years of experience in HPLC impurity analysis handling within the food testing industry. The ideal candidate should have a strong foundation in analytical chemistry, method development, and instrument calibration. Key Responsibilities: Perform HPLC impurity analysis in accordance with regulatory and laboratory standards. Conduct routine calibration and maintenance of HPLC instruments. Ensure accurate documentation of sample preparation, analysis, and results. Adhere to Good Laboratory Practices (GLP), ISO 17025 standards, and safety protocols. Assist in method development and validation as per standard operating procedures. Maintain and update instrument logs and calibration records to support audit readiness. Collaborate with QA/QC teams to ensure compliance and continuous improvement. To analyze all Food & Agri samples using HPLC as per IS, AOAC, FSSAI , SOP and customer supplied methods. To Calibrate and perform Intermediate checks for all major and minor laboratory instruments such as HPLC, pH meter, micropipette, sonicator etc. To analyze all the food & Agri samples using GC and UV-Visible spectrophotometer as per IS, AOAC, FSSAI and customer supplied methods. To develop, validate and verify methods as per requirement using HPLC & GC. Candidate Requirements: M. Sc - Chemistry. 1 to 3 years of relevant experience in HPLC and GC techniques, preferably in a food testing laboratory. Hands-on experience with chromatographic software and analytical instrumentation. Willingness to work in rotational shifts. Flexibility to relocate to other branches across India including Bangalore, Nellore, Nashik, Mumbai, Ahmedabad, and Noida for deputation or transfers. Strong analytical skills, attention to detail, and effective communication abilities. Regards, Priyanka Jajula Sr. Executive - HR
Posted 1 month ago
1 - 4 years
2 - 4 Lacs
Ahmedabad
Work from Office
quality checks on raw materials, in-process, and finished product proper documentation as per GMP standard stability studies, sampling, and lab testing compliance with SOPs, regulatory, and safety guideline audits and assist in CAPA implementation
Posted 1 month ago
10 - 15 years
8 - 10 Lacs
Hyderabad
Work from Office
Job Description: 1 . Hands on Experience in regulatory submissions preferably for Blood products and Biologics. 2. Review/Submission of applications for new products Manufacturing licenses and renewals. 3. Experience on procedures for application of new drugs (NOC's and Test licenses). 4. Monitoring and ensuring allp certificates (COPPs, GMP, GLP, WHO-GMP and FSC Production Capacity and Performance Certificate) renewals and approvals up to date. 5. Review of Tender certificate. 6. Co-ordinate with Drug control authority personnel for License approvals. 7. Review of Dossiers. 8. Submission of Samples and Documents to NIB, Noida for testing. 9. Updation of the National and international legislation, guidelines and customer practices. 10. Approval of Artworks. 11. Undertake and manage regulatory inspections. 12. Responsible to handle the SUGAM portals and Online Drug licencing system and National single window system (NSWS). 13. Complete knowledge on ROW and EU market registration. 14. Query response submission received from various M. 15. Coordination with the relevant departments for completion of Regulatory works.
Posted 1 month ago
6 - 10 years
7 - 8 Lacs
Baddi
Work from Office
Job Description Position : Senior Executive Quality Assurance Section : Quality Assurance Grade/Band : 1C Qualification : M.Sc. /B. Pharm. Desirable Experience: 06 - 10 years Followings will be the responsibilities of the position holder: To ensure effective implementation of system and procedure as per cGMP, cGLP and other Regulatory requirements, and monitor its compliance in laboratory. To participate in investigation of laboratory error report, incidents, out of trend and out of specification results and review the investigation report. To handle & coordinate QMS through SolTRAQs. To ensure the effective implementation of QMS through SolTRAQs application system. To participate in investigation exceptions, market complaints and out of specification results and review the investigation report. To act as a laboratory compliance administrator for creation of new users and projects and to review the audit trials. Compliance of QMS related SOPs and records. Ensuring the Compliance to EPD Global Guidelines. Facing internal and external audits and ensuring compliance. Implementation of GLP / GMP requirements. Coordinating and aligning the practices and procedures in line with the COBC requirements. Any other task assigned by reporting manager. JOB FAMILY: Operations Quality t
Posted 1 month ago
- 3 years
2 - 5 Lacs
Hyderabad/ Secunderabad
Work from Office
Walk-In Drive : Analytical Services Required Qualification & Experience: M.Sc. Chemistry/Analytical/M-Pharmacy, with 0 - 3 Years of experience in the field of pharmaceutical industry/CRO setup. Candidate should have knowledge in method development and validations by GCMS /LC-QTOF. Candidate should have knowledge on GLP/cGMP. Good to have experince in E&L. Job Responsibilities Carries out experimentation in the area of GCMS/LC-QTOF for E&L studies. Records experimental data, ensuring clear and accurate transcription of results and calculations. Completes assigned work with quality and in a timely manner. Assists the group leader in instrument qualifications, implementing laboratory procedures and systems. Coordinates with other team members as per requirement. Follows QMS (cGMP/GLP) practices and aspects related to policies, safety and compliance. Performs in-charge duties for the allocated lab/equipment/inventory/supporting activities and takes responsibility for the timely completion of the tasks assigned. Demonstrates a strong desire to continue learning and grow personal capability. Performs other duties as assigned. Please bring your Updated CV along with 3 Months Payslips, Recent Increment Letter, Aadhar Card/PAN Card: Date : Saturday, 17th May 2025 Time: 09:00 AM to 4:00 PM Walk-in Interview Location: Daicel Chiral Technologies (India) Pvt Ltd Genme Valley, IKP Knowledge Park, Survey No. 542/2, Koltur Village, Shamirpet Mandal, Medchal-Malkajgiri District, Hyderabad-500101 Note: Candidates who are unable to walk-In, May send their resume to hr@chiral.daice.com or whatsApp to 7207760479
Posted 1 month ago
1 - 5 years
1 - 3 Lacs
Ahmedabad
Work from Office
Vendor approvals (RM/PM) GMP training & implementation Regulatory compliance Product complaints & recall Batch release QMS execution & audits Validation, deviations & change control
Posted 1 month ago
2 - 7 years
2 - 7 Lacs
Hyderabad, Navi Mumbai, Ahmedabad
Work from Office
Openings for Residue analysis persons in Food Testing - Hyderabad , Navi Mumbai , Ahmedabad Designation : Junior / Senior Analyst Experience: 2- 10 Years Department : Residue Location : Hyderabad Qualification : M.Scs. (Organic Chemistry/Chemistry/Analytical chemistry) Industry : CRO & Testing Laboratory (Third party testing lab ) Roles and Responsibilities: Analysis of Pesticide residues of Food and Agriculture products as per SOPs, IS, AOAC, FSSAI. Method development, validation and report preparation. Operation and Calibration of equipment i.e., LC-MS/MS, GC-MS/MS, Analysis of Pesticide residues in Water samples. Analysis of Antibiotics in Aqua & Marine products, Feed, Milk & Milk products. Analysis of Pesticide Residues in Fruits and vegetables, Milk & Milk products, Feed & Feed Products and Miscellaneous samples. Mycotoxin analysis in Food & Agricultural products and feed samples. Use and calibration of instruments such as Micro Pipettes, Analytical Balance, Micro balance, Centrifuge, Turbo Evaporator, HPLC & GC. Analysis of Residue in food by LC MS/MS,GC MS/MS, method development and validation, food additives, contaminants analysis on HPLC,GC with different detectors, Worked in ISO 17025:2017 and FSSAI approved lab NABL audit will be added advantage. Regards, Priyanka Jajula
Posted 1 month ago
1 - 7 years
3 - 4 Lacs
Ahmedabad
Work from Office
Dishman Group is looking for Officer - QC to join our dynamic team and embark on a rewarding career journey Conduct quality checks on raw and finished goods. Ensure compliance with manufacturing standards. Document defects and corrective actions. Assist in internal audits and inspections.
Posted 1 month ago
2 - 7 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 QUALITY ASSURANCE IPQA (Injectable), IPQA (OSD) & QMS / Documentation / Validation and Qualification (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. Injectable Manufacturing 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 / Dispensing / QMS (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification B Sc / M Sc / B. Pharmacy/ M Pharmacy / Diploma Time and Venue : 17th May 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. Preferred candidate profile *Having relevant qualification as mentioned above can attend the scheduled walk-in.
Posted 1 month ago
5 - 10 years
2 - 6 Lacs
Hyderabad
Work from Office
Scientific Business Analyst (Specialist) – ELN What you will do This role involves working 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 maximises 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 multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements scientific software platforms such as Laboratory Information Management Systems (LIMS) that enable the capture of lab workflows & experimental data and Electronic Lab Notebooks (ELN) that act as Amgen’s System of Record ensuring data integrity and business continuity. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and landmarks Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor’s degree with 6 - 8years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience with Benchling, Revvity, IDBS, or similar LIMS/ELN platforms Preferred Qualifications: 5+ years of experience in designing and supporting biopharma scientific software platforms. Good-to-Have Skills: Experience leading the implementation of scientific software platforms, Electronic Lab Notebook (ELN), or Laboratory Information Management Systems (LIMS) Experience handling GxP data and system validation, and knowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP) Experience in AI and machine learning for drug discovery research and preclinical development Experience with cloud (e.g. AWS) and on-premise infrastructure In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Experience in establishing business partnerships and IS governance practices involving senior business stakeholders Knowledge of business analysis standard processes, DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 1 month ago
2 - 7 years
2 - 5 Lacs
Thane
Work from Office
Job description Position Offers: Designation : QA Officer/Executive Reports to : Head Location : Precise Analytics Laboratory - Thane Wagle Estate Qual. : (MSC Chemistry/Nutraceuticals/Food Science/M Pharm Quality Assurance) Exp. : 2-3 years experience in Food Analysis . Industry : Only pharma company Open position : 1 Roles and Responsibilities 1) Knowledge of analytical methods and Instruments with software 2) Verification of reports of analysis and reports of method validation 3) Verify the implementation of laboratory management system and GLP 4) Maintenance of lab records. 5) Knowledge of ISO 17025:2017 standard. 6) Control of records and documents 7) Knowledge of IQC, ILC, PT testing
Posted 1 month ago
3 - 8 years
3 - 7 Lacs
Baddi
Work from Office
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 analysis as per requirement from Outside Commercial Lab as and when required. Calibration of instruments, as and when required. Preparation of volumetric solution, reagent, and test solution, as and when required. Ensuring the timely updation in the documents as per the Pharmacopeial amendments. Responsible for maintaining the resource in the quality control department. To ensure the compliance of the requirement of cGDP/cGDP and Data integrity while performing all activities in the laboratory. Ensuring the Compliance to EPD Global Guidelines. Facing internal and external audits and ensuring compliance. Implementation of GLP / GMP requirements. Coordinating and aligning the practices and procedures in line with the COBC requirements. SOP training in Isotrain of self-train within stipulated time.
Posted 1 month ago
4 - 5 years
7 - 8 Lacs
Mumbai
Work from Office
Job Overview To lead and execute analytical method validation, transfer, and verification activities in compliance with regulatory and cGMP standards, ensuring robust analytical support for product development, regulatory submissions, and commercial manufacturing. Competencies Plan, perform, and document Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) for raw materials, intermediates, and finished drug products. Prepare and review protocols and reports related to method validation / verification / transfer in alignment with ICH Q2(R1) guidelines. Coordinate with R&D, AR&D, QA, RA, and manufacturing units for method transfer and troubleshooting activities. Perform routine and non-routine analysis using HPLC, UPLC, GC, UV, IR, dissolution apparatus, and other analytical instruments. Ensure timely qualification/calibration of instruments used in AMV lab. Review analytical documents like raw data, chromatograms, validation reports, SOPs, etc. Support regulatory inspections (USFDA, EU, ANVISA, WHO, etc.) and respond to queries related to AMV/AMT. Investigate OOS/OOT/Deviation/Incident related to AMV activities and provide effective CAPA. Maintain GLP and cGMP compliance across AMV operations. Experience: 4 -5 years in QC-AMV in a regulated pharmaceutical environment M.Sc. (Chemistry/Analytical Chemistry) / M.Pharm
Posted 1 month ago
4 - 5 years
7 - 8 Lacs
Mumbai
Work from Office
Job Overview To lead and execute analytical method validation, transfer, and verification activities in compliance with regulatory and cGMP standards, ensuring robust analytical support for product development, regulatory submissions, and commercial manufacturing. Competencies Plan, perform, and document Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) for raw materials, intermediates, and finished drug products. Prepare and review protocols and reports related to method validation/verification/transfer in alignment with ICH Q2(R1) guidelines. Coordinate with R&D, AR&D, QA, RA, and manufacturing units for method transfer and troubleshooting activities. Perform routine and non-routine analysis using HPLC, UPLC, GC, UV, IR, dissolution apparatus, and other analytical instruments. Ensure timely qualification/calibration of instruments used in AMV lab. Review analytical documents like raw data, chromatograms, validation reports, SOPs, etc. Support regulatory inspections (USFDA, EU, ANVISA, WHO, etc. ) and respond to queries related to AMV/AMT. Investigate OOS/OOT/Deviation/Incident related to AMV activities and provide effective CAPA. Maintain GLP and cGMP compliance across AMV operations. Experience: 4 -5 years in QC-AMV in a regulated pharmaceutical environment M. Sc. (Chemistry/Analytical Chemistry) / M. Pharm
Posted 1 month ago
1 - 6 years
3 - 8 Lacs
Nashik
Work from Office
Role: Officer / Executive - Quality Control Job Location: Nashik At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via: Access Providing high quality trusted medicines regardless of geography or circumstance; Leadership Advancing sustainable operations and innovative solutions to improve patient health; and Partnership Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make a difference and here's how this role, will make an impact: Role Purpose Seeking for candidates (Male/Female) with sound qualification background to ensure the testing of drug product in Quality control lab and to ensure every product is of the highest quality. They shall be concerned with sampling, specifications, testing, documentation, release procedures which ensure that the necessary and relevant tests are carried out under the norms of cGMP. Role & responsibilities Candidate must have relevant experience in Quality control OSD and QMS and able to operate & maintain laboratory equipment/instruments (HPLC, GC, Malvern Particle sizer, dissolution apparatus etc.) as per procedure. To maintain documents as per GLP requirements. To ensure the calibration status of laboratory equipment & instruments. To report and involve in incidence/Deviation/OOS/OOT investigations. Candidate must have sound exposure in the Quality Control Laboratory to supervise and maintain documents and retention of records as per GMP requirements. To ensure the review of QC documents like analytical reports SOPS, Qualification, Logbooks, Raw data sheet, analytical records, calibration and ensuring compliance to observations with proper root cause and justifications. Candidates participate in initiation, review, and closure of OOS/OOT and monitor the CAPA with implementation in Track wise. To ensure the compliance of the Corrective and Preventive Actions (CAPA) necessitated through various activities such as Regulatory Audits, Market Complaints, and Product Recall & Annual Product Review in the QC if applicable. To support Quality Assurance / Compliance /Regulatory Systems, Processes and ensure Monitoring, Execution, Initiation of the Quality Management Systems in Quality Control laboratory. Qualification & Experience Candidate must be B. Pharm/ M. Pharma/ M. Sc In Chemistry Experience- Candidate must have 2 to 6 years experience in a reputed pharma industry. Candidates must be willing to work in shifts Candidate who have faced regulatory Audits like FDA & MHRA Audit will be preferred.
Posted 1 month ago
12 - 18 years
10 - 14 Lacs
Pune, Hinjewadi
Work from Office
We are hiring for a Public listed BSE / NSE - Pharma - API / Crop Protection / Animal Health Intermediates Mfg CDMO / CRAM Company. Role : Team Leader - ADL Title : Sr. Scientist R&D Centre Level : Deputy Manager CTC : Ceiling Rs 15 Lpa Experience: Minimum 14 years to Max 18 years Those working at R&D Centres of Crop Sciences / API / Specialty Chemicals are only eligible. Formulations / Vaccines / Bio labs are not eligible. Formulations Qualification : Full Time M.Sc in Organic Chemistry / Analytical Chemistry only. Those in other specialisation of Chemistry are not eligible. Those with Correspondence Masters degree won't qualify. Location: Pune Saturdays: 2nd / 4th Not working Local Company Transport on the major Trunk Road available. Those working in QC Labs not eligible. Those working in Foods Lab not eligible. Those working in Testing Laboratories should not apply. Role: To follow Good laboratory Practices. To follow the procedures mentioned in SOP's and General test Procedures To ensure availability of respective working standards/samples for method validation and method transfer activity To monitor periodic calibration of instruments as per the schedule To follow all safety standards while working To fulfil the requirement of RA department for different filings To review method validation data & preparation of respective protocol reports To ensure documentation of analytical activities as per Co. policy To provide complete support for internal & external Audits at Pune location To develop suitable analytical methods to support cross functional teams To prepare and review method validation protocols, data and reports
Posted 1 month ago
5 - 9 years
7 - 9 Lacs
Ankleshwar, Panoli
Work from Office
Position: Astt Manager - QA Qualification: B.Sc / M.Sc in Chemistry Experience: 6 years to 10 years in QA CTC can go maximum to Rs 9 Lacs per Annum. Location: Ankleshwar / Panoli. Transport Provided. Industry: API PHARMA ONLY Responsibility: Support MR in QMS Responsible for driving Quality Mindset. Support IMS Audits, FDA , Vendor Audits. Strong in Document Control and Process Documentation. Should have supported US FDA Inspections and Audits KEYWORDS: GMP, FDA, IMS, QMS, AUDITS
Posted 1 month ago
7 - 12 years
5 - 10 Lacs
Halol, Vadodara
Work from Office
Key Responsibilities Quality Strategy & Planning Develop and implement quality control standards, procedures, and policies. Define inspection criteria and quality benchmarks. Team Management Lead and supervise a team of quality inspectors or analysts. Provide training and guidance to QC staff. Manage and supervise QC laboratory activities Use effective negotiation skills to drive alignment and resolve conflict Inspection & Testing Oversee routine inspections and testing of raw materials, in-process, and finished products. Ensure compliance with internal and external specifications and regulations. Documentation & Reporting Maintain detailed records of quality control activities. Analyze QC data and generate reports to identify trends and areas for improvement. Compliance & Audits Ensure compliance with ISO, GMP, or other industry-specific standards. Coordinate and support internal and external audits. Problem Solving Investigate product quality issues and customer complaints. Implement corrective and preventive actions (CAPA).
Posted 1 month ago
10 - 15 years
8 - 15 Lacs
Bengaluru
Work from Office
We are seeking a highly motivated and experienced Study Director to oversee chemical characterization studies within our research and development team. The ideal candidate will have a strong background in analytical chemistry, extensive knowledge of chemical characterization techniques, and a proven track record in managing complex projects. Key Responsibilities: - Lead and manage chemical characterization studies, including planning, execution, and reporting of results. - Develop study protocols and ensure compliance with regulatory guidelines and internal standards. - Coordinate and communicate with cross-functional teams. - Analyze and interpret data, preparing comprehensive reports and presentations for internal and external stakeholders. - Mentor and train junior staff in scientific techniques and best practices. - Ensure that laboratory safety protocols are followed and maintain a clean and organized work environment. - Stay current with industry trends and advancements in chemical characterization methodologies. Qualifications: - Ph.D. or equivalent degree in Chemistry, or a related field. - A minimum of 10 years of experience in chemical characterization or a similar role within a laboratory setting. - Expertise in techniques such as LCMS - QTOF, GCMS, NVR, ICPMS, IC and other relevant analytical methods. - Strong project management skills with the ability to lead multiple projects simultaneously. - Excellent communication, organizational, and problem-solving abilities. - Familiarity with regulatory requirements and guidelines in the pharmaceutical or biotechnology industry. This position offers a competitive salary and benefits package, along with opportunities for professional growth and development. If you are passionate about advancing scientific research and thrive in a collaborative environment, we encourage you to apply. Roles and Responsibilities 1. Oversee and manage chemical characterization studies from initiation to completion, ensuring adherence to regulatory standards and internal protocols. 2. Design study plans and methodologies that are scientifically sound and aligned with project objectives, including the selection of appropriate analytical techniques and equipment. 3. Coordinate with cross-functional teams, including project managers, chemists, and quality assurance personnel, to ensure effective study execution and communication. 4. Review and approve study protocols, analytical methods, and reports to ensure accuracy, compliance, and scientific integrity. 5. Provide technical expertise and guidance related to chemical characterization, including the interpretation of analytical data and results. 6. Ensure that all studies are conducted in compliance with Good Laboratory Practice (GLP) and other relevant regulations. 7. Manage study budgets and timelines, identifying potential risks and implementing mitigation strategies to ensure successful project delivery. 8. Train and mentor staff on appropriate methodologies and regulatory requirements related to chemical characterization studies. 9. Participate in project meetings, presenting study findings and progress updates to stakeholders, and incorporating feedback into study design and implementation. 10. Maintain up-to-date knowledge of industry trends, emerging technologies, and regulatory changes affecting chemical characterization and related fields. 11. Facilitate communication with regulatory agencies as needed, providing data and documentation to support submissions and inquiries. 12. Contribute to the continuous improvement of departmental processes and methodologies, ensuring best practices are followed in study design and execution.
Posted 1 month ago
6 - 10 years
6 - 10 Lacs
Hyderabad
Work from Office
Oversee the implementation, maintenance, and continuous improvement of GLP systems and processes. Investigate and resolve any GLP-related deviations, non-conformances, or audit findings. Develop and maintain SOPs related to GLP compliance.
Posted 1 month ago
9 - 14 years
7 - 9 Lacs
Chennai
Work from Office
JOB DESCRIPTION OF SENIOR RESEARCH SCIENTIST QUALITY Qualification - M. Sc. /M. Phil. /Ph. D in Chemistry Experience - 15 years in Quality Control/Assurance Industry -Toiletries/Cosmetics/Personal Care/Pharma Technical requisites : Hands-on experience in the following areas : 1. Ability to handle independently instrumental and chemical analytical laboratory 2. Analytical method development and validation 3. Stability study evaluation of products 4. Quality Management system and audits 5. Document and data control 6. Preparation of documents for drug/product licensing 7. Ensuring compliance to Drug & Cosmetics Act & Rules, GMP/GLP and regulations of Weights and measures act and rules 8. Product dossier preparation 9. Training Quality personnel in laboratory quality systems and management 10. Exposure in handling market complaints and root cause analysis 11. Exposure in handling Export regulations and documentation 12. Exposure in handling Halal/ISO/AYUSH License documentation
Posted 1 month ago
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