7 Edqm Jobs

About The Role : Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deutsche Bank has long been recognized as a leader in the provision of administrative and fiduciary services to the global debt and equities markets. It supports structures from the simplest to the most complex, covering Asset Backed Securities, CLOs and Managed accounts, Corporate Debt, Escrows, Project Finance, Loan Agency, and Depositary Receipts. OverviewTeam: TAS Analytics group within Corporate Trust business of Deutsche Bank is supporting the Structured Finance products like ABS/MBS/CDOs and other Debt products like Syndicated Loan transactions where DB acts as Trustee and/or Agent. As Trustee and/or Agent, DB is responsible for performing various calculations including but not limited to Bond Payments and Tax Calculations for new and existing bond issuances. Group has exposure to Corporate Trusts business in understanding the Structured Finance and other Debt products and its Analytics requirements along with supporting the CSG activities. The successful candidate will be required to cover European working hours supporting the EMEA/Americas business. Corporate title will depend on the relative experience of candidate. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Flexible working arrangements Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Read and interpret governing legal and issuer documents namely Prospectuses/Offering Circulars, Bond Indentures and Pooling and Servicing Agreements, Hedging Agreements, etc. Process and review Bond Payments for MBS, ABS, CDO and similar kinds of structured product deals in an In-House platform (iMAKE) based on the Offering Circulars/Indenture/Pooling & Servicing Agreement and using the best practices followed in the Group. Offer the highest level of customer service by understanding overall deal structure and bond payments to provide internal and external clients with explanations to support cash flow model output. Establish the guidelines for receipt and appropriate format of underlying asset-level collateral that supports bond payments, as well as research and resolve any data accuracy issues. Involvement in ad hoc/special projects which support process improvement and the implementation of technology initiatives. Understand and analyze issues and offer practical solutions. Working independently with a minimal degree of supervision is required to exercise independent judgment. Your skills and experience Bachelor of Science/Engineering or qualified CA/CFA with a high GPA and a minimum of 2 years of professional experience. Previous experience in developing cash flow models, and exposure to securities industry. Must have proven skills in MS Excel and/or MS Access with good scripting skills in VBA. Experience in using SQL Demonstrated ability to handle multiple and often competing projects under tight deadlines and pressure. Must project a Customer/Client service focus. Responsible for supporting efforts to mitigate and control operational risk. Must be organized, focused, and possess strong communication and analytical skills. Demonstrated ability to work and think independently, while supporting team goals/objectives. How we'll support you Training and development to help you excel in your career Flexible working to assist you balance your personal priorities Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management . Key Responsibilities Include: Generate and execute of global and country-specific regulatory strategies Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop global dossiers for CMC content for initial submissions, variations and amendments Support change management activities Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment Knowledge and Skills CMC- specific regulatory knowledge & experience Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

We have been retained by a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development to hire a "Consultant - Regulatory Affairs" to be based at their HO located at Navi Mumbai. Details of the position are mentioned below: Company: Our Client is a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development. They have their head office in Mumbai and subsidiaries in Europe, Singapore, Australia and Malaysia. They have been providing high quality & credible consulting services to the Pharmaceutical Industry in India and internationally. They have a young and committed team of GMP and Regulatory Experts. Role & responsibilities: The person will be responsible for Regulatory consulting services at the firm. The responsibilities of this position include, but are not limited to, the following: Ownership for assigned regulatory projects including dossier writing, submissions, approval tracking, query resolution across Developed markets (UK, Australia, EU and US) and Emerging markets Ensure regulatory compliance, accuracy, timely completion, version control & adherence to internal SOPs Providing strategic input to the Management and Partners on regulatory projects Keep abreast of new developments in regulations across all critical health authorities Experience & Qualifications Regulatory affairs experience in small molecules for a minimum of 3-8 years is mandatory Must be well versed with ICH CTD guidelines and other regulatory guidelines from developed markets (US, EU, UK etc). Must have hands-on experience in regulatory submissions pertaining to generics/ small molecules (m1-m5 CTD writing for EU, Australia and other markets) CEP/ DMF/ ASMF filing with a good knowledge of EDQM requirements would be advantage. Experience in biologics/ biosimilar filings will be an added benefit. Computer and technical skills (including eCTD software knowledge) Strong & Flawless communication skills. Accuracy and attention to detail. Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak, Director, Pharma Placements Inc. Mobile: 98202 34987 / 81307 24980

- Must have good knowledge of Regulatory Submissions and Research - Must be familiarity with chemical industry specific regulations and guidelines. - Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies Required Candidate profile - Ensure company products with relevant regulatory requirements such as USFDA, FDA, EMA, and local regulations. - Stay up-to-date with changing regulatory requirement to internal stakeholders.

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Any job assigned by immediate supervisor/HOD Preferred candidate profile Experience required - Pharma API background Perks and benefits As per industry

Hiring for Jr. Executive / Sr. Executive for RA - API with 2 to 5 Years of experience.

Hello Candidate, Greetings from Hungry Bird IT Consulting Services Pvt Ltd. We are hiring Production Manager - API Manufacturing for our client a leading pharmaceutical manufacturing company dedicated to API/Intermediate. Company: Leading Pharmaceutical API Production Company Location: 1) Hyderabad, 2) Visakhapatnam About the Company: Active Pharmaceutical Ingredient manufacturing company, robust product portfolio spread over major product segments encompassing Expectorants, Muscle Relaxants, Analgesic and Anti Fungal. Job Description We are seeking a highly skilled and experienced Production Manager to oversee the production operations of our Active Pharmaceutical Ingredient (API) manufacturing facility. The ideal candidate will have a deep understanding of API manufacturing processes, particularly in the areas of expectorants, muscle relaxants, analgesics, and anti-fungal APIs. Key Responsibilities: Production Planning and Scheduling: Develop and implement comprehensive production plans and schedules to meet customer demands and optimize resource utilization. Monitor production progress and adjust plans as needed to ensure timely delivery. Process Optimization: Continuously evaluate and improve existing production processes to enhance efficiency, reduce costs, and improve product quality. Implement innovative technologies and techniques to optimize production yields and minimize waste. Quality Assurance: Ensure strict adherence to cGMP, ISO, and other relevant regulatory standards. Oversee quality control procedures, including sampling, testing, and documentation. Collaborate with the Quality Assurance team to identify and resolve quality issues promptly. Team Management: Lead and motivate a team of production personnel to achieve production goals. Provide training and development opportunities to enhance employee skills and knowledge. Foster a positive and collaborative work environment. Regulatory Compliance: Stay updated on regulatory requirements and industry best practices. Ensure compliance with all applicable regulations, including FDA, EDQM, and WHO guidelines. Prepare and submit regulatory documentation as required. Safety and Environmental Compliance: Implement and enforce strict safety protocols to minimize workplace accidents and injuries. Promote a culture of safety and environmental responsibility. Ensure compliance with environmental regulations and waste management guidelines. Troubleshooting and Problem-Solving: Identify and troubleshoot production issues, such as equipment malfunctions, process deviations, or quality problems. Implement effective solutions to minimize downtime and maximize productivity. Qualifications and Experience: Bachelor's or Master's degree in Pharmacy, Chemical Engineering, or a related field. Minimum of 10 years of experience in API manufacturing, with a strong focus on expectorants, muscle relaxants, analgesics, and anti-fungal APIs. In-depth knowledge of API manufacturing processes, including synthesis, purification, and formulation. Strong understanding of cGMP, ISO, and other regulatory requirements. Proven track record of leading and managing production teams. Excellent problem-solving, decision-making, and analytical skills. Strong communication and interpersonal skills. Ability to work under pressure and meet tight deadlines. If you are a highly motivated and experienced Production Manager with a passion for API manufacturing, we encourage you to apply. (Interested candidates can share their CV to krishna@hungrybird.in or call on 9966952299.) Please furnish the below-mentioned details that would help us expedite the process. PLEASE MENTION THE RELEVANT POSITION IN THE SUBJECT LINE OF THE EMAIL. Example: KRISHNA, HR MANAGER, 7 YEARS, 20 DAYS NOTICE Name: Position applying for: Total experience: Relevant Experience: Notice period: Current Salary: Expected Salary: Thanks and Regards Krishna +91 9966952299