1074 Glp Jobs - Page 9

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary This role will develop experimental approaches and will be responsible for ana...

Design & Implementation of cGLP for Pharmaceutical laboratory ensuring compliance with Global Quality guidelines, local FDA (Schedule M & L) and other regulatory requirements of importing countries and Zentiva Quality standard. Ensure analytical method validation and transfer. Responsible for review and approval of SOPs, recording formats, test methods - specification, validation protocol / report, qualification and calibration of record of laboratory equipment, OOS/OOT/deviation investigation and re-analysis/fresh analysis decision, management of reference standards, Retained sample Management and training on GLP. Ensure the maintenance of laboratory premises and equipment. Manage Pharmaceu...

Support testing of LIMS functionalities to ensure the functionality available, is working as per users expectation as well as it meets the approved user requirement specification. Develop testing strategy and execute it to meet the implementation timelines. Perform the impact assessment of newly added functions on the existing functionalities. Rigorously test the newly introduced functionalities based on its impact on the existing functionalities. Provide training and support to end-users, ensuring they are proficient in using the LIMS. Troubleshoot and resolve any issues related to LIMS performance, functionality, and integration with other systems/instruments. Maintain comprehensive docume...

Support in implementation and configuration of the sLIMS, ensuring alignment with laboratory workflows and regulatory requirements. Execute the tasks defined in project plans, adhering to timelines, for successful implementation of sLIMS. Configure sLIMS software to meet the specific needs of the laboratory, configuring workflows, and setting up user roles and permissions. Provide training and support to end-users, ensuring they are proficient in using the sLIMS. Troubleshoot and resolve any issues related to sLIMS performance, functionality, and integration with other systems/instruments. Maintain comprehensive documentation of the sLIMS implementation process, including user guides and tec...

Support in QC/R&D lab instrument integration with LIMS application, at the time of LIMS implementation at various locations of SUN Pharma. Develop and execute test scripts, and relevant documentations required as part of validation activity. Configure LIMS software to meet the specific needs during Instrument integration activity. Provide training and support to end-users, ensuring they are proficient in using the LIMS. Troubleshoot and resolve any issues related to LIMS performance, functionality, and integration with other systems/instruments. Maintain comprehensive documentation of the LIMS implementation process, including user guides and technical manuals. Shall be aware about documenta...

Job Title: Executive – R&D Biotechnology Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” JOB DESCRIPTION The candidate is expected to develop HP...

Utility Operator HVAC / Water / Electrical (01 Position) based in Vapi, Gujarat. The ideal candidate brings 5 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvemen...

The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Plan resources, ensure statutory compliance, drive traini...

The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Additional info: Key Skills: DMF Compilation, QA Coordinat...

Micro Head based in Kathua, Jammu & Kashmir. The ideal candidate brings 12 - 15 yrs exp. and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Lead mi...

Assistant Manager / Sr. Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improveme...

Chemist (On Contract) (MP 25/20) based in Narmada, Gujarat. The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen...

HVAC & Water System Engineers 2 Posts based in Amritsar. The ideal candidate brings 2 - 4 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen)...

HPLC Operator (01 Position) based in Vapi, Gujarat. The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Ope...

Autocad Operator 1 Pos based in Amritsar. The ideal candidate brings 6-7 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Operate and tro...

Boiler Engineer (On Contract) (MP 25/19) based in Narmada, Gujarat. The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lea...

QC Head 1 Pos based in Kathua, Jammu & Kashmir. The ideal candidate brings 12 - 15 yrs exp. and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Mana...

Chief Manager Township Administration (MP 25/13) based in Narmada, Gujarat. The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement...

Sterile Manufacturing based in Waghodia, Vadodara. The ideal candidate brings 1- 7 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Additio...

Analysis of raw materials, in-process, finished products using HPLC, GC, UV-Vis,& titration. Maintain instruments, ensure doc as per SOPs & cGMP. Support method transfer, prepare reports,coordinate with QA and Production while ensuring lab safety.

oversee l operations and quality systems in a regulated CRO environment. ensuring microbiological data integrity, method development/validation, audit , and compliance (e.g., GLP, GMP, GCLP, ISO). Lead a team of microbiologists and QA personnel,

As a Sr. Manager - Micro Lead at Sun Pharmaceutical Industries Ltd in Ahmednagar, your role is crucial in overseeing the activities in Microbiology department. **Key Responsibilities:** - Planning, reviewing, and monitoring overall activities in Microbiology department - Coordinating with other departments to prioritize tasks and provide timely support/testing to avoid delays - Reviewing all departmental documents and results in LIMS system, ensuring completeness on time - Reviewing lysate sensitivity test, Bacterial endotoxin test of WFI and API products - Checking method validation of bacterial endotoxin test and microbial quality of products - Procuring, receiving, storing, maintaining, a...

Position Title: Executive Quality Control, Pharmaceuticals Requirements & Qualifications M.sc (Organic / Analytical Chemistry) / B. Pharm with 3-5 years of Experience as an analyst in similar industry GMP & GLP knowledge Good coordination & communication skills. Job Overview Implement quality control activities at Ankleshwar adhering to regulatory / global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet with customers requirements. Responsibilities Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods and other samples. Performing analys...

Role Overview: You will be responsible for managing biospecimens collected for clinical studies, working closely with Clinical Teams to develop and implement biospecimen management plans for Phase 1-4 clinical trials. Your role will involve overseeing the complete lifecycle of biospecimens, ensuring timely delivery of specimen data, and facilitating quick decision-making processes to maintain a competitive advantage. Key Responsibilities: - Oversee and manage biospecimens collected for clinical studies with minimal supervision. - Provide shipping/sample movement and management support to Clinical Team members, including handling requests, queries, and inventory reports. - Follow up on active...

Job Title: Quality Assurance (QA) Clinical Research Experience: 810 years Location: Indiranagar, Bangalore Department: Quality Assurance About the Role MSCR is seeking an experienced QA professional with strong expertise in ICH-GCP and GLP principles to ensure the highest standards of quality and compliance across clinical research and laboratory operations. The ideal candidate will be well-versed in regulatory guidelines, clinical QA processes, and GLP compliance, with proven experience in audits, CAPA management, and continuous quality improvement initiatives. Key Responsibilities Clinical QA (ICH-GCP Focus) Develop and maintain ICH/GCP-compliant processes to control the quality of work an...