Amandeep kaur’s Post

Reasons why we are following the issues in our Pharma Industry -Regulatory Audit failures - Passing the regulatory audits with struggle and prayers -Fear of un-informed regulatory audits -Feeling Headache for the local regulatory audits - No root cause in OOS Investigations -Inefficiency in the plants - Low yield and inefficient processes - Struggling to file the updates in the processes to the regulatory authorities -Attrition rate not under control -Revision the formats and procedures always like a railway train -Reducing profit margins of existing products -Dip in the selling price of rhe existing Molecules - Fast changing the regulatory requirements -Political turmoil in the international politics - Buisness dips down with the change in management Points to be concentrated -Quality of Manpower Technical staff in the operations are very very poor in English. Reading and understanding. Even the majority of them cannot write the uppercase and lower case alphabets. Please check and verify; you will be astonished from the outcome which you are going to get. - Lacking in basis knowledge of science however they are working in total scientific field like Basic organic, inorganic and physical, analytical, medicinal, biochemistry, polmer and theoretical chemistry. - They don't the reactions in the products they are manufacturing. - Poor understanding of the functions of the equipments and instruments. - No understanding of the role of Raw materials, intermediates, APIs, solvents and excipients and they the depth process and chemistry and operational details. -Sound scientific Chemical processes in APIs and physical processes are not developed in Research and Development. The same are transferred for usage to the plants. So these processes are not giving consistent results. - Lower intermediate, raw material, Excipient manufacturers are not communicating the changed done at their end to the API and formulation manufacturers, - Unstable and non- uniform utilities -More Work posers than actual doers of the work. Any body Who want to under stand the point wise issues can message so that we can reply. Definitely every question has an answer. There is no problem in the world which cannot be resolved. Only Will required which is not there in the people. Regards -

I wanted to share with you all a little insight into my 19 years of journey in the fascinating world of regulatory affairs. Starting Point: Fresh from my MBA( Power) course, when I embarked on my career in regulatory affairs, I had a clear vision of contributing to the development and compliances in power sector. It all began with a passion for regulatory research and a desire to make a difference in people's lives. Challenges Faced and Overcame: During my journey, I encountered several challenges that tested my perseverance and determination. The ever-evolving regulatory landscape, complex guidelines, and constantly changing requirements presented hurdles at every turn. However, I embraced these challenges as opportunities for growth. Through continuous learning and staying updated with the latest regulations, I overcame obstacles and found innovative solutions to ensure compliance while meeting business objectives. Lessons Learned: My career in regulatory affairs has taught me valuable lessons that I carry with me every day: 1) Adaptability is key: The regulatory environment is dynamic, and being open to change is crucial for success. 2) Collaboration is vital: Working closely with cross-functional teams and stakeholders fosters a holistic approach to compliance and regulatory strategy. 3) Continuous learning is essential: Staying up-to-date with regulations, industry trends, and new technologies is vital for professional growth. 4) Persistence pays off: Overcoming challenges requires perseverance, determination, and a positive mindset. Looking back, I am proud of how far I have come in my regulatory affairs career. The journey has been challenging, yet immensely rewarding. I am grateful for the opportunities to contribute to the development of innovative strategies in retail supply competition while ensuring adequate returns and regulatory compliance. If anyone has any questions or would like to share their own experiences in the regulatory affairs field, please feel free to comment below. Let's connect and inspire each other! #RegulatoryAffairs #CareerJourney #ChallengesFaced #LessonsLearned #karnpallav

🌟 𝐓𝐡𝐫𝐢𝐥𝐥𝐞𝐝 𝐭𝐨 𝐒𝐡𝐚𝐫𝐞! 🌟 I’m delighted to announce that I’ve earned a new certification: 𝐈𝐧𝐭𝐫𝐨𝐝𝐮𝐜𝐭𝐢𝐨𝐧 𝐭𝐨 𝐆𝐌𝐏 𝐀𝐧𝐧𝐞𝐱 1 from Pharmuni ! Achieving my Good Manufacturing Practice (GMP) certification has greatly enhanced my skills as a chemist, ensuring I maintain the highest standards of quality and safety in all my work. This certification has enriched my knowledge of regulatory compliance, quality control, and risk management, enabling me to contribute effectively to the production of safe, reliable, and top-quality chemical products. With this expertise, I am well-prepared to innovate in the fields of nanochemistry, biosensors, and polymer research, ensuring that my work not only meets but surpasses industry standards, ultimately driving advancements that benefit both the scientific community and society at large. This course has been incredibly beneficial, and I’ve gained: - Mastery in compliance with the highest standards in chemical manufacturing, reinforcing my commitment to quality and safety in the lab. - Expertise in quality assurance and regulatory compliance in the chemical industry. - Comprehensive understanding of Good Manufacturing Practices, essential for maintaining the integrity and safety of chemical processes and products. - Strengthened knowledge of GMP to support quality control and ensure adherence to industry standards in chemical production. - Insight into the importance of regulatory compliance and quality assurance in chemistry. - A dedication to excellence and safety in the field of chemistry. - The ability to drive quality improvement and regulatory adherence in chemical manufacturing processes. - Focus on maintaining the highest standards in chemical production through thorough GMP training. - Enhanced proficiency in quality management and regulatory compliance within the chemical industry. - Commitment to ensuring the highest level of safety and quality in chemical manufacturing through GMP certification. #ProfessionalDevelopment #GMP #QualityAssurance #RegulatoryCompliance #ChemicalIndustry #Innovation #Nanochemistry #Biosensors #PolymerResearch

Nerhadou International, 6th of October, Giza GMP Senior Compliance Specialist Job Description Investigation the deviations received from different departments, investigation & root cause analysis & review of reports to be reviewed by compliance supervisor. Implementation of CAPA system, ensure that all approved CAPAS are tracked and communicated to all concerned parties & follow-up of CAPA plans implementation and effectiveness. Implement change control system, evaluation of changes & checking appropriate timeline implementation. Implement of product quality review plan and initiate reports annually for all products. Investigation of customer complaints. Implementation of the plan for quality risk management in production areas, warehouses & Quality control, Ensure that all potential and existing quality risks are tracked, Review quality risk management reports to be evaluated by compliance supervisor. Ensure compliance with GMP pharmaceutical guidelines and ISO Standards, Quality Management System and Data Integrity tracking of vendor management / supplier evaluation system including raw/ packaging materials suppliers, toll manufacturers, Bio-equivalence centres and other service providers. Participate in Handling external audits from different local and external regulatory bodies and licensors. tracking quality agreement with suppliers to ensure all contractual quality requirements are fulfilled. Implement the system for qualification of outsourced activities s and suppliers according to pre-set criteria and follow up annual performance to issue updated approved list. Share in Internal audit program, plan issuance and execution, follow up of CAPA implementation. Job Requirements Proven work experience as a Compliance Specialist or similar role Strong analytical and critical thinking skills Excellent verbal and written communication skills Documenting and reporting skills Computer knowledge Good English language Proficiency in MS Office (MS Excel & word) https://lnkd.in/dTU3EfMV #manufacturing #vacancy #pharmaceutical #recruiting #jobvacancy #jobalert #vacancy #qualitycontrol #qualitycontrolanalyst #qualityanalyst #Otsukapharmaceutical #Obourcity #QC #QCanalyst #regulatoryaffairs #pharmaceuticalindustry #pharmaceutical #CTD #cmc #Regulatory #Pharma #pharmacy #science #Hiring #vacancy #pharmaceuticals #pharmacist #pharmaceuticalmanufacturing #hospital_pharmacist #hospitals #qualitycontrol #quality_control #veterinarymedicine #qualitysystems #qualityassurance #quality_control_professional #egypt #sciencejobs #sciencejobs #pharmaceutical #pharmaceuticalindustry #pharmaceuticalmanufacturing #pharma #pharmacy #pharmacists #sciencejobs #biochemistry #agriculture #agriculturelife #fresherjobs #freshers2024 #freshers2023 up, mention and share please follow to see more jobs #antonious_fares

Nerhadou International, 6th of October, Giza QC Supervisor Raw material & Packaging material. Job Description Review, Check & follow up on all activities in the QC lab (Chemist lab). Responsible for ensuring that all new hires in the QC lab (Chemist lab) are well qualified through the reports of senior analysts. Reviewing & Checking of the protocols & Reports. Volumetric solution Preparation. Standard management system. Aware references (ICH – FDA – ISO17025 - Reference pharmacopoeia) & any reference update. Reviewing & Checking all packaging materials with approved artwork. Job Requirements Bachelor of Science, or pharmacy. Good manners. Work under pressure. Problem solving & Logic thinking. An Organized person. Teamwork. Has ability to improve & is able to learn. Good Communication skills. Basic Quality tools. Quick intuitive – humility. Team leader. Soft Skills (Time Management, Team Building) https://lnkd.in/dcdgbQ72 #manufacturing #vacancy #pharmaceutical #recruiting #jobvacancy #jobalert #vacancy #qualitycontrol #qualitycontrolanalyst #qualityanalyst #Otsukapharmaceutical #Obourcity #QC #QCanalyst #regulatoryaffairs #pharmaceuticalindustry #pharmaceutical #CTD #cmc #Regulatory #Pharma #pharmacy #science #Hiring #vacancy #pharmaceuticals #pharmacist #pharmaceuticalmanufacturing #hospital_pharmacist #hospitals #qualitycontrol #quality_control #veterinarymedicine #qualitysystems #qualityassurance #quality_control_professional #egypt #sciencejobs #sciencejobs #pharmaceutical #pharmaceuticalindustry #pharmaceuticalmanufacturing #pharma #pharmacy #pharmacists #sciencejobs #biochemistry #agriculture #agriculturelife #fresherjobs #freshers2024 #freshers2023 up, mention and share please follow to see more jobs #antonious_fares

good opportunity

𝗚𝗢𝗢𝗗 𝗟𝗔𝗕𝗢𝗥𝗔𝗧𝗢𝗥𝗬 𝗣𝗥𝗔𝗖𝗧𝗜𝗖𝗘-𝗚𝗟𝗣 Ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations. 𝙀𝙨𝙨𝙚𝙣𝙩𝙞𝙖𝙡 𝙀𝙡𝙚𝙢𝙚𝙣𝙩𝙨 𝙤𝙛 𝙂𝙤𝙤𝙙 𝙇𝙖𝙗𝙤𝙧𝙖𝙩𝙤𝙧𝙮 𝙋𝙧𝙖𝙘𝙩𝙞𝙘𝙚 𝙌𝙪𝙖𝙡𝙞𝙩𝙮 𝙈𝙖𝙣𝙖𝙜𝙚𝙢𝙚𝙣𝙩 It's the importance of a robust quality management system to ensure that all aspects of a study are conducted in accordance with predefined protocols and procedures. This includes documentation of all study procedures, data collection, analysis, and reporting. 𝙁𝙖𝙘𝙞𝙡𝙞𝙩𝙞𝙚𝙨 𝙖𝙣𝙙 𝙀𝙦𝙪𝙞𝙥𝙢𝙚𝙣𝙩 The must maintain appropriate facilities and equipment to ensure the accuracy and reliability of data. This includes calibration and maintenance of instruments, proper storage of chemicals and samples, and appropriate laboratory conditions 𝙚𝙭𝙖𝙢𝙥𝙡𝙚-𝙩𝙚𝙢𝙥𝙚𝙧𝙖𝙩𝙪𝙧𝙚, 𝙝𝙪𝙢𝙞𝙙𝙞𝙩𝙮 as required by the study protocol. 𝙋𝙚𝙧𝙨𝙤𝙣𝙣𝙚𝙡 It's appropriately trained and qualified to perform their assigned tasks. Standard operating procedures, safety practices, and data recording requirements. Clear lines of responsibility should be established to ensure accountability for each aspect of the study. 𝙎𝙩𝙖𝙣𝙙𝙖𝙧𝙙 𝙊𝙥𝙚𝙧𝙖𝙩𝙞𝙣𝙜 𝙋𝙧𝙤𝙘𝙚𝙙𝙪𝙧𝙚𝙨-𝙎𝙊𝙋𝙨 GLP requires the development and implementation of SOPs for all critical laboratory procedures. SOPs help to standardize processes, minimize variability, and ensure consistency in data collection and reporting. 𝘿𝙤𝙘𝙪𝙢𝙚𝙣𝙩𝙖𝙩𝙞𝙤𝙣 𝙖𝙣𝙙 𝙍𝙚𝙘𝙤𝙧𝙙-𝙠𝙚𝙚𝙥𝙞𝙣𝙜 All data, observations, calculations, and interpretations must be recorded in a timely manner and maintained in an organized and secure manner to facilitate review and audit. 𝙎𝙩𝙪𝙙𝙮 𝙋𝙧𝙤𝙩𝙤𝙘𝙤𝙡 The study protocol that outlines the objectives, design, methodology, and data analysis procedures. Any changes to the protocol must be documented, justified, and approved by the study director before implementation. 𝙌𝙪𝙖𝙡𝙞𝙩𝙮 𝘼𝙨𝙨𝙪𝙧𝙖𝙣𝙘𝙚 Quality assurance activities, including internal and external audits, are essential to verify compliance with GLP standards and identify any deficiencies or opportunities for improvement. 𝗖𝗔𝗣𝘼 - 𝗖𝗼𝗿𝗿𝗲𝗰𝘁𝗶𝘃𝗲 𝗮𝗻𝗱 𝗽𝗿𝗲𝘃𝗲𝗻𝘁𝗶𝘃𝗲 𝗮𝗰𝘁𝗶𝗼𝗻𝘀 should be implemented in response to audit findings to ensure ongoing compliance. 𝙍𝙚𝙥𝙤𝙧𝙩𝙞𝙣𝙜 The accurate and transparent reporting of results, including any uncertainties or limitations in the data. The final report should include a detailed description of the study design, methods, results, and conclusions, presented in a format that is clear and understandable to regulatory authorities. #GLP #pharmaceutical #diagnostic #Foodindustry #laboratory #AnithaGnanasekaran

#job_openings See the below post/attached pdf for detailed information To #stayinformed on the latest #jobopenings & #openpositions by #connecting with me on LinkedIn! #jobs #openpositions #Biotechjobs #microbiologyjobs #lifesciencejobs #MolecularBiologyJobs #careeroppurtunities #Labopportunities #ResearchJobs #LifeSciCareers #clinicalresearch #opportunities2024 #postdoc

Challenges to the Regulatory Affairs Profession It will be understandable that the regulatory affairs challenges emerge from multi-dimensional characteristics of the profession: * Dealing with people with diverse backgrounds, skills, cultures, and personalities. * Receiving input from various departments within the organization about product attribute specifications to fulfill regulatory requirements * Guided by multiple regulatory guidelines that are continuously updating * Processes are time-framed; therefore, a quick response is required with maximum quality. To handle these challenges, regulatory affairs professionals need to acquire and develop the following qualifications: * Excellent navigation skills to keep updated with all new guidelines and regulations * Well-organized with appropriate time management. * Outstanding communication and negotiation skills * Proactive, to be always prepared for emerging events and continuous changes. #Regulatory_for_All