Job Title: Technical Specialist - MSAT Experience: 7 to 10 Years Position Type: Permanent Location: Bengaluru OUR COMPANY Global Value Web (GVW) is a value chain enabling company headquartered in The Netherlands with offices across North America, Europe, and India in global value chains of Pharmaceutical / Life Science, Chemical and Oil & Gas/Energy companies. Through remote and on-site managed services, GVW strives to assist the client’s talent, from scientists, business professionals, managers and directors, so they can focus on what they do best - their core areas. GVW then manages the contextual or enabling services by gathering, cleansing, organizing, curating, and analyzing the data involved. Through advanced digital/informatics solutions further advances the overall capability of our clients to process their product-related data, all the way from research, through development, as well as commercial manufacturing, quality control and delivery. Enabling reliable capabilities at our client’s side with the right balance of People, Data, Process & Technology. For more than 15 years, GVW continues to work with some of the largest Pharmaceutical and Life Science companies worldwide in transforming their entire value chain/network from sub-optimized stove pipes and nodes, towards a patient or customer centric focused network of capabilities, incl research labs, development labs, planning & manufacturing capabilities, plus quality labs and delivery entities. Making their digital transformation dreams a reality. OUR PEOPLE Our people have a rich tradition of working side by side with our customers as long-term partners, developing tailored solutions that help customers deliver business success in their local markets. Every day, with our passion, commitment to excellence and innovation, our people create specialized and custom solutions designed to make our customer’s business sustainable and run seamlessly. KEY RESPONSIBILITIES BOM and Specification Setup: Ø Develop and maintain accurate Bills of Materials (BOMs) and detailed specifications for chemicals & polymers. Ø Collaborate with CMOs to ensure alignment with their systems and procedures. Ø Conduct thorough reviews of existing specifications to identify potential gaps or inconsistencies. Comparability Assessments: Ø Evaluate the comparability of different suppliers and grades of chemicals, considering factors such as quality, purity, and performance. Ø Conduct rigorous testing and analysis to assess the impact of potential substitutions or changes. Specification Method Alignment: Ø Work closely with Johnson & Johnson Quality Control (QC) to align specification methods and testing procedures. Ø Ensure consistency and compliance with regulatory requirements. Change Control Assessments: Ø Evaluate proposed changes to chemical specifications or sourcing and assess their potential impact on product quality and regulatory compliance. Ø Prepare comprehensive change control documentation and facilitate the review and approval process. Risk Assessments: Ø Identify and assess potential risks associated with chemical components, including supply chain disruptions, quality issues, and regulatory changes. Ø Develop mitigation strategies to minimize risks and ensure business continuity. Technical Transfer Support: Ø Provide technical support to CMOs during the technology transfer process, addressing questions and resolving issues related to chemical specifications and testing. Ø Conduct training and knowledge transfer sessions to ensure a smooth transition. Key Interaction Areas Ø Drug Product Development, supply chain stakeholders, CMOs, Regulatory CMC/LOC, Spec management team, Tech Transfer Team Quality & Compliance Responsibilities Ø Is responsible for the proper recording of Ensures that records and raw data are properly retained. SKILLS REQUIRED · Education & Certifications – MSc. or M. Pharm · Strong understanding of pharmaceutical manufacturing processes and regulatory requirements (e.g., GMP, ICH). · Experience in technical transfer activities, including BOM and specification development. · Proficiency in data analysis, decision making and problem-solving skills. · Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams. · Strong attention to detail and organizational skills. · Ability to work independently and manage multiple tasks simultaneously. Key Selection Criteria · Knowledge of Regulatory Requirements (eg: cGMP, ICH) · Comparability assessments between suppliers and grades · Change control assessments · Risk assessments related to chemicals · Basic knowledge on specification methods and alignment between CMO’s and Clients QC labs. WHAT’S ON OFFER? At Global Value Web, we provide a better quality of life for our clients and patients. The Technical Specialist-MSAT will play a pivotal role in ensuring that services meet the company’s quality standards and comply with regulatory requirements. By joining our team, you will have the opportunity to lead transformative initiatives that directly impact the well-being of those we serve.
Job Title: Technical Specialist - MSAT Experience: 7 to 10 Years Position Type: Permanent Location: Bengaluru OUR COMPANY Global Value Web (GVW) is a value chain enabling company headquartered in The Netherlands with offices across North America, Europe, and India in global value chains of Pharmaceutical / Life Science, Chemical and Oil & Gas/Energy companies. Through remote and on-site managed services, GVW strives to assist the client's talent, from scientists, business professionals, managers and directors, so they can focus on what they do best - their core areas. GVW then manages the contextual or enabling services by gathering, cleansing, organizing, curating, and analyzing the data involved. Through advanced digital/informatics solutions further advances the overall capability of our clients to process their product-related data, all the way from research, through development, as well as commercial manufacturing, quality control and delivery. Enabling reliable capabilities at our client's side with the right balance of People, Data, Process & Technology. For more than 15 years, GVW continues to work with some of the largest Pharmaceutical and Life Science companies worldwide in transforming their entire value chain/network from sub-optimized stove pipes and nodes, towards a patient or customer centric focused network of capabilities, incl research labs, development labs, planning & manufacturing capabilities, plus quality labs and delivery entities. Making their digital transformation dreams a reality. OUR PEOPLE Our people have a rich tradition of working side by side with our customers as long-term partners, developing tailored solutions that help customers deliver business success in their local markets. Every day, with our passion, commitment to excellence and innovation, our people create specialized and custom solutions designed to make our customer's business sustainable and run seamlessly. KEY RESPONSIBILITIES BOM and Specification Setup: ؠDevelop and maintain accurate Bills of Materials (BOMs) and detailed specifications for chemicals & polymers. ؠCollaborate with CMOs to ensure alignment with their systems and procedures. ؠConduct thorough reviews of existing specifications to identify potential gaps or inconsistencies. Comparability Assessments: ؠEvaluate the comparability of different suppliers and grades of chemicals, considering factors such as quality, purity, and performance. ؠConduct rigorous testing and analysis to assess the impact of potential substitutions or changes. Specification Method Alignment: ؠWork closely with Johnson & Johnson Quality Control (QC) to align specification methods and testing procedures. ؠEnsure consistency and compliance with regulatory requirements. Change Control Assessments: ؠEvaluate proposed changes to chemical specifications or sourcing and assess their potential impact on product quality and regulatory compliance. ؠPrepare comprehensive change control documentation and facilitate the review and approval process. Risk Assessments: ؠIdentify and assess potential risks associated with chemical components, including supply chain disruptions, quality issues, and regulatory changes. ؠDevelop mitigation strategies to minimize risks and ensure business continuity. Technical Transfer Support: ؠProvide technical support to CMOs during the technology transfer process, addressing questions and resolving issues related to chemical specifications and testing. ؠConduct training and knowledge transfer sessions to ensure a smooth transition. Key Interaction Areas ؠDrug Product Development, supply chain stakeholders, CMOs, Regulatory CMC/LOC, Spec management team, Tech Transfer Team Quality & Compliance Responsibilities ؠIs responsible for the proper recording of Ensures that records and raw data are properly retained. SKILLS REQUIRED Education & Certifications MSc. or M. Pharm Strong understanding of pharmaceutical manufacturing processes and regulatory requirements (e.g., GMP, ICH). Experience in technical transfer activities, including BOM and specification development. Proficiency in data analysis, decision making and problem-solving skills. Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams. Strong attention to detail and organizational skills. Ability to work independently and manage multiple tasks simultaneously. Key Selection Criteria Knowledge of Regulatory Requirements (eg: cGMP, ICH) Comparability assessments between suppliers and grades Change control assessments Risk assessments related to chemicals Basic knowledge on specification methods and alignment between CMO's and Clients QC labs. WHAT'S ON OFFER At Global Value Web, we provide a better quality of life for our clients and patients. The Technical Specialist-MSAT will play a pivotal role in ensuring that services meet the company's quality standards and comply with regulatory requirements. By joining our team, you will have the opportunity to lead transformative initiatives that directly impact the well-being of those we serve.