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#hiring *Chemist, Engineer - Quality Management, API Manufacturing (m/f/d)*, Karlsruhe, *Germany*, fulltime #jobs #jobseekers #careers #Karlsruhejobs #Baden-Wurttembergjobs #ScienceTechnology *Apply*: https://lnkd.in/gahtWdDE CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients and pharmaceutical Drug Products (DP) and packaging capabilities with > 2'600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives. Our network in Europe and the US offers flexible and specialized solutions across five technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients. To strengthen our Global team in Plankstadt between Heidelberg and Mannheim we are looking as soon as possible for a Global Quality Excellence Manager 100% (m/f/d) Plankstadt ASAP Full-time Permanent Enable and lead a quality network team of CordenPharma s API sites to promote and foster a Culture of Continuous Improvement for API analysis and manufacturing by leading interdisciplinary Quality Excellence initiatives. Act as a Subject of Matter Expert for GxP compliance of API operations & analysis and drive for further digitalization. Lead input into the concept design and detailed GxP layout of new state-of-the-art API manufacturing facilities and upgrade of existing facilities to contemporary standards. Ensure GMP readiness of new API facilities including pre-licensing preparation and efficient startup. Master the complexity of the API manufacturing processes within the group and understand the potential sources of variability using the digital GxP systems. Promote the principles of process design and the development of a comprehensive control strategy for manufacturing APIs of consistent quality by ensuring a practical application of quality target product profile (QTPP), quality-by-design (QbD), identification and mitigation of risks and process characterization. Support the parallel development of a testing strategy that encompasses all stages of manufacturing from starting materials, in-process testing through drug substance release testing and stability testing. Enable phase-appropriate approaches to synthetic, hybrid and semisynthetic technologies are required. Participate in international working groups as Global CP representative, e.g. for Peptides. Conduct internal audits to elevate particular areas of risk or concern for API production and enforce remediation action to support inspection readiness and increase API process robustness. Enable and moderate Quality ad-hoc boards in case o

#hiring *Chemist, Engineer - Quality Management, API Manufacturing (m/f/d)*, Mannheim, *Germany*, fulltime #jobs #jobseekers #careers #Mannheimjobs #Baden-Wurttembergjobs #ScienceTechnology *Apply*: https://lnkd.in/gFt_erQ3 CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients and pharmaceutical Drug Products (DP) and packaging capabilities with > 2'600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives. Our network in Europe and the US offers flexible and specialized solutions across five technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients. To strengthen our Global team in Plankstadt between Heidelberg and Mannheim we are looking as soon as possible for a Global Quality Excellence Manager 100% (m/f/d) Plankstadt ASAP Full-time Permanent Enable and lead a quality network team of CordenPharma s API sites to promote and foster a Culture of Continuous Improvement for API analysis and manufacturing by leading interdisciplinary Quality Excellence initiatives. Act as a Subject of Matter Expert for GxP compliance of API operations & analysis and drive for further digitalization. Lead input into the concept design and detailed GxP layout of new state-of-the-art API manufacturing facilities and upgrade of existing facilities to contemporary standards. Ensure GMP readiness of new API facilities including pre-licensing preparation and efficient startup. Master the complexity of the API manufacturing processes within the group and understand the potential sources of variability using the digital GxP systems. Promote the principles of process design and the development of a comprehensive control strategy for manufacturing APIs of consistent quality by ensuring a practical application of quality target product profile (QTPP), quality-by-design (QbD), identification and mitigation of risks and process characterization. Support the parallel development of a testing strategy that encompasses all stages of manufacturing from starting materials, in-process testing through drug substance release testing and stability testing. Enable phase-appropriate approaches to synthetic, hybrid and semisynthetic technologies are required. Participate in international working groups as Global CP representative, e.g. for Peptides. Conduct internal audits to elevate particular areas of risk or concern for API production and enforce remediation action to support inspection readiness and increase API process robustness. Enable and moderate Quality ad-hoc boards in case of A

Happy to have completed the intensive Pharmaceutical Manufacturing Diploma from Innovation Academy!🌸 During this diploma, I gained in-depth knowledge and practical experience in various factory departments, including: 🔍 Production Department: - Factory development - Dispensing area - Solid department - Syrup department - Packaging department 🔬 Quality Control (QC) Department: - Quality control lab - Microbiology lab 📊 Quality Assurance (QA) Department: - In-process control of dispensing, solids, and syrup packaging 🧪 Research and Development (R&D) Department: - Formulation development - Methodologies - Stability studies Looking forward to applying these skills in my future career in the pharmaceutical industry! #PharmaceuticalManufacturing #QualityControl #QualityAssurance #ResearchAndDevelopment #ProfessionalGrowth #ContinuousLearning

𝗪𝗵𝗮𝘁 𝗶𝘀 𝗟𝗶𝗻𝗲 𝗖𝗹𝗲𝗮𝗿𝗮𝗻𝗰𝗲 𝗜𝗻 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗜𝗻𝗱𝘂𝘀𝘁𝗿𝗶𝗲𝘀? Line clearance is a crucial process in the pharmaceutical industry that ensures the safety and quality of products being manufactured. It involves a thorough inspection and verification of equipment, facilities, and materials before starting a new batch production or after completing a batch. 𝗧𝗵𝗲 𝗹𝗶𝗻𝗲 𝗰𝗹𝗲𝗮𝗿𝗮𝗻𝗰𝗲 𝗽𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲 𝘁𝘆𝗽𝗶𝗰𝗮𝗹𝗹𝘆 𝗰𝗼𝗻𝘀𝗶𝘀𝘁𝘀 𝗼𝗳 𝘁𝗵𝗿𝗲𝗲 𝗽𝗮𝗿𝘁𝘀 𝗖𝗹𝗲𝗮𝗿𝗶𝗻𝗴 The physical removal of any materials from the previous process that are not necessary for the next process 𝗖𝗹𝗲𝗮𝗻𝗶𝗻𝗴 The disinfection and drying of all surfaces and equipment 𝗖𝗵𝗲𝗰𝗸𝗶𝗻𝗴 A supervisor or quality manager inspects the line thoroughly before the next scheduled process can begin. The main goal of line clearance is to prevent cross-contamination and ensure that all previous product residues, debris, and documentation have been removed before a new production batch begins. This process safeguards product integrity and aligns with Good Manufacturing Practices (GMP). The line clearance procedure should ensure that all materials, products, labels, and records from previous operations have been removed. The person responsible should initial the batch record to show that a clearance check has been carried out. The line should also be clearly labeled to show the product and its strength to be packaged. 𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝗰𝗲 𝗼𝗳 𝗟𝗶𝗻𝗲 𝗰𝗹𝗲𝗮𝗿𝗮𝗻𝗰𝗲 ▪️Prevents chances of mix up. ▪️Assures the quality of the product. ▪️Assures cleaning of the area and equipment. 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗮𝘀𝘀𝘂𝗿𝗮𝗻𝗰𝗲 𝗼𝗳𝗳𝗶𝗰𝗲𝗿 𝗰𝗵𝗲𝗰𝗸𝘀 𝗳𝗼𝗹𝗹𝗼𝘄𝗶𝗻𝗴 ▪️Cleaning of doors, walls and ceiling. ▪️Cleaning of windows and HVAC ducts etc ▪️Checking of equipment. ▪️Surface below the equipment should be checked for the previous product leftovers. ▪️Calibration status of weighing balance. ▪️Temperature and humidity of the area. ▪️Differential pressure of the area. After ensuring all the requirements of the area and equipment the product to be processed is checked. 𝗙𝗼𝗹𝗹𝗼𝘄𝗶𝗻𝗴 𝗴𝗲𝗻𝗲𝗿𝗮𝗹 𝗽𝗮𝗿𝗮𝗺𝗲𝘁𝗲𝗿𝘀 𝗮𝗿𝗲 𝗰𝗵𝗲𝗰𝗸𝗲𝗱 ▪️Batch number of the product. ▪️Lot number of the product. ▪️Quantity or weight of the ingredients or components. #microbiology #pharmaceutical #qualityassurance #pharma #lineclearance #30dayschallenge #day09 #vijaykumarh

Opportunities

good opportunity in Delhi ncr

Since May.2023 to July.2024 in MAS pharmaceutical industry should be say: “ The journey of a thousand miles begins with a single step. “ That was a great chance to be part of the founding team of a company from its opening until to #GFDA inspection. Especially if this is in the #sterile pharmaceutical industries. To keep the memory, I will share what I got in this short time Relatively: • Issuing and reviewing documents “This stage includes Change control record and new issues SOP’s”. • #Water_System_Qualification “ This stage includes phase 1, phase 2 and long time stage phase 3". • Aseptic Manufacturing Procedure #Media_fill Every 6 months, in this stage help us to evaluate the effectiveness of the aseptic processing systems. • #Filling 3 Pilot Patch and start stability studies with Qc (Chemical & Microbial). • Environmental Monitoring in Microbiology lab, Production area and any area need to microbial control. • Finally, #GFDA inspection for Accreditation of Manufacturing site, That tha great experience! In adding, reading, searching for information at pharmaceutical industry in all Departments. To be honest Work under pressure, teamwork, and time management can work wonders. ♥️ #Amman #Jordan #opentowork #Desperate

pharmaceutical solids process

Hello everyone. I am looking for new role in Quality Control/Quality assurance in pharmaceutical API or formulation, In my profile: I have 18 years experience in regulated pharmaceutical companies and dosage form Tablets, capsule, injactable, oral suspension, I have exposure of lead auditee in USFDA, MHRA, TGA, ANVISA. Etc. I have exposure of green field project, CSV. Cleaning validation, AMV, failure investigation, compliance, Vendor Management, instruments qualification, big size team Management, Quality policy framing, Auditing, e-data Management, paperless Quality system development, GMP training, Software Life Cycle Management, stability study, ANDA submission, develope Data Integrity Management system, warning letter Remediation, response submission to regulatory agencies, contract laboratories audits, CAPA Development and trending, area Quality, mediafill validation, QbD, Process Validation, nitroso impurity risk assessment, personal qualification etc. Reach or inform at me on 9317611174, #pharmaceutical #QC #QA #auditing #vendormanagement #injactable #osd #greenfield #brownfield #qualification #validation #csv #sunpharma #lupin #Emcure #zydus #alembic #aurobindo #hetero #regulatory #cmo #cro #torrent #Baxter #panacea #cadila #Glenmark #biological #esai #generalmanager #dgm #Qualityhead #projectmanagement #stability studies #ANDA #Market #consulting

#OpportunityAlert: Know someone for this job? Could you tag them in the comments to share with them? #hiring #jobseekers #careerists #jobs #careers #jobopportunity #jobopportunities #careeropportunity #careeropportunities courtesy https://lnkd.in/eJFHduU