4089 Gmp Jobs - Page 34

Opportunity to work with a leading Indian pharmaceutical company Opportunity to drive R&D initiatives About Our Client Our client is a leading Indian multinational pharmaceutical company headquartered in Ahmedabad, Gujarat, with a strong presence in generics, biosimilars, and specialty medicines across more than 85 countries. Job Description The key responsibilities include: Strategic Leadership & Innovation Define and execute R&D strategies for plasma-derived products in alignment with company objectives. Lead the development of new plasma-derived therapeutics: IVIG, Albumin, Factor VIII/IX, Anti-D, etc. Collaborate with executive leadership on pipeline planning and long-term innovation roa...

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...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Cytiva, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological re...

To perform the cleaning activity of allocated area, compression equipment's like compression machines, combo deduster, instruments, containers, accessories etc as per their respective SOP. To perform the operation activity of allocated area, compression equipment's like compression machines, combo deduster, instruments, as per their respective SOP. To fill and maintain all documents like BMR, Log book and other formats as per SOP. To upkeep and maintain the area/ equipment's as per cGMP requirement. To maintain the status label of area, equipment , instrument, material, containers and accessories as per SOP. To control and minimize production loss during manufacturing activity. To take activ...

Job Purpose To ensure the plants operational continuity by managing preventive and corrective maintenance, overseeing facility upgrades and support EHS initiatives. To provide uninterrupted and quality services to associates in line with Site and corporate protocol and laid down Safety Norms. To be proactive to avoid any breakdown, Ensuring proper Utilisation of available infrastructure, modification, and upgradation of infrastructure as per the requirement. Effective coordination with Engineering team for modification, repairs, and maintenance of workplace areas like Admin Office bldg., conference/meeting rooms, cafeteria, common areas, Residential colony, and Guest house for Civil, Electri...

Role & responsibilities Troubleshoot and resolve issues related to A3, filling machines, HACCP, GMP, ISO standards, preventive maintenance, and breakdowns. Provide technical support for machine operating and maintenance engineering on beverage production lines. Implement downtime reduction strategies to minimize equipment failures and optimize productivity. Collaborate with cross-functional teams to ensure compliance with FMCG industry regulations and standards. Conduct regular inspections of machinery to identify potential problems before they become major issues. Preferred candidate profile 8-10 years of experience in a similar role within the FMCG/beverage industry. Diploma or B.Tech/B.E....

Active involvement in all upstream manufacturing activities. Perform error free operation by eliminating operational gaps in advance. Active trouble shooting to minimize the various risks prior to execution and during execution. Initiate and process upstream deviations /investigations and closure. Pre -execution activity: Area and equipment readiness. Issuance of raw material /consumables and issuance batch records. Upstream process execution: Batch process operation /unit operation (including CIP, SIP and preparation upstream accessories), close monitoring of batch performance and data. Follow and practice on-line documentation all the time. Follow cGMP practices during the manufacturing ac...

Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and busines...

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...

Supplier Quality Management: Develop, implement, and maintain a robust supplier quality assurance system aligned with cGMP and regulatory requirements (e.g., USFDA, EMA, WHO). Lead supplier qualification, requalification, and performance monitoring programs. Conduct risk-based assessments and ensure supplier categorization based on product and service criticality. Auditing & Compliance: Plan, conduct, and follow up on supplier audits (on-site and remote) for API, excipient, packaging, and service providers. Evaluate audit findings, identify gaps, and oversee closure of CAPAs with suppliers. Maintain audit schedules, records, and ensure timely reporting. Maintenance of Approved Supplier List ...

Management and control of SOPs, Master documents, labels & other GMP impacted documents Implementing necessary quality systems at the site including complaint Investigation, qualification and validation, change control, deviation and non-compliance management, documentation, supplier quality assurance etc Out of specification & Out of trend investigation Deviation Investigation Incidence investigation Review of Batch Manufacturing Records (BMRs), Analytical record & related documentation Validation & Qualification Change control review & management Preparing the Annual Product Review and Annual Quality Review Batch Rework/Reprocessing Approval Approval of repacking, relabeling and non-standa...

Serve as a liaison between CMs and Lilly. Provide quality oversight of CMs including being the initial point of contact for all quality related issues. Escalate quality issues at CMs to Lilly QA management. Assist in the establishment and revisions of Quality Agreements with affiliates and customers. Provide quality oversight of Lilly/APIEM Quality Plans Coordinate and perform QA responsibilities of API shipments. Participate in regulatory inspection preparations with CMs. Provide on-site support during manufacturing events and inspections. Participate on the Technical Review Board Evaluate and disposition API batches, if required. Ensure that documented checks have been completed for the Ce...

Independent experimental planning and execution to meet program goals and schedules. Timely record keeping of results into data sheets and laboratory note-books. Regular mining of literature and keeping oneself up to date with developments in field of antibody development and protein biology. Ideate effectively to recommend improvements in product development and workflows. Compilation and presentation of data in written and oral formats to different audiences including stakeholders and leadership. Active participation in team meetings. Mentoring junior scientists and provide in-lab supervision.

Responsibilities: * Conduct BPR reviews * Ensure compliance with GMP & Change Control procedures * Monitor product quality through IPQA processes * Collaborate on BMR development and maintenance * Implement BPRs as needed Food allowance Annual bonus Provident fund

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...

Role: QA/QC Chemist Loc: Choutuppal,Valigonda Exp: 5+ yrs in Quality Control within the API/API Intermediate Manufacturing Sal: 6 - 8 LPA Qual: BSc/MSc (Chemistry) Skills: instrumental analysis (HPLC, GC, UV, IR, KF, etc. HPLC, GC SRUTHI 8125254983

Candidate having rich experience in food safety requirement. * product validation test * microbiology testing control * GMP warehouse internal auditing * quality and food safety.

We are looking for a skilled Restaurant Manager to join our team, with 4-8 years of experience in the hospitality industry. The ideal candidate will have a strong background in managing restaurants and excellent leadership skills. Roles and Responsibility Manage daily restaurant operations, including staff supervision and customer service. Develop and implement strategies to improve customer satisfaction and increase sales. Maintain high standards of food quality, safety, and hygiene. Analyze sales reports and develop plans to boost revenue. Lead and motivate a team of employees to achieve exceptional performance. Ensure compliance with health and safety regulations and company policies. Job...

QC for F&V – inbound, storage, handling & dispatch, Ensure compliance with FSSAI & food safety norms, Conduct regular quality audits & inspections, Monitor & act on key KPIs Knowledge of cold chain, post-harvest tech, , HACCP, GHP, GMP

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 3- 8 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). Own production execution and shift supervision; ensure lin...