71 Mhra Jobs - Page 3

Designation: Analytical Quality Assurance and Documentation Job Location: Mangalore Department: MSEZ- Quality Assurance About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve RD productivity, speed up time to market and lower the cost of innovation. Job Purpose: Manager - Quality Assurance Educational Qualification: M.Sc. (Chemistry), B Pharma/M Pharma or any other equivalent university degree. Experience: 10 to 15 Years Job Description: Well-versed in all national and international regulatory agency requirements such as ICH, USFDA, WHO Geneva, PMDA Japan, EDQM, MHRA, TGA, etc., for API manufacturing. Responsible for evaluation and approval of vendors/subcontractors and service providers of small molecule drug substances, followed by qualification of testing laboratories. Review and approve SOP, Analytical method validation, verification, Calibration reports, and other analytical reports of QC, QCM, and TSD. Review of Audit trails. Plan and coordinate review meetings to ensure the continuing suitability, adequacy, and effectiveness of the quality system. Approval of URS, impact assessment, protocols, and reports related to qualification and validations of facility/area, equipment, and utilities in manufacturing facility, QC, and warehouse. Well versed in usage of electronic QMS tools such as Learning Management System (LMS), Laboratory Information Management System (LIMS), Trackwise, Document Management System (DMS). Release or rejection of raw materials, intermediates, finished products, packaging, and labeling materials. Review and approval of Process, Cleaning, Analytical Method validation/transfer, Computerized system validation, Hold time, Spreadsheets, and all other validation/qualification protocols and reports, including raw data. Ensuring End-to-end activities of Document control, Archival, and Destruction at the Site. Ensure availability of optimum resources and operate the department within the specified budget. Support Department Head in preparing the annual budget. Key Responsibilities: Maintaining a robust QMS in accordance with regulatory requirements (e.g., ICH, FDA, EMA). Being responsible for regulatory inspections and audits, and managing responses and corrective actions. Ensuring compliance with data integrity policy and identifying the cause of non-compliance. Providing training and development programs for QA personnel to ensure understanding of regulatory requirements and quality standards. Promoting a culture of quality and compliance throughout the organization. Performing self-inspections and ensuring manufacturing operations are maintained in an audit-ready state at all times (ATAR). Ensuring the archival of documents and third-party archival activities within SLA and ensuring compliance from the respective departments. Adhering to safe practices and procedures personally and ensuring teams are aligned with safety standards. Technical/functional Skills: Good communication skills and experience in API industry. Behavioural Skills: Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team. Good speaking-listening-writing skills, attention to details, proactive self-starter. Ability to work successfully in a dynamic, ambiguous environment. Ability to meet tight deadlines and prioritize workloads. Ability to develop new ideas and creative solutions. Should be able to work in team and flexible for working in shifts. Should be a focused employee. Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Job Title: Manager-Plant Maintenance Block A Position: Manager-2 Job Grade: G11A No. of Direct Reports (if any): 09 Function: Engineering & Projects. Location: Dadra Areas of Responsibility 1. To ensure 100% Maintenance of all Plant Machinery process Equipments (Granulation equipments-FBD, FBE, RMG, Blender, Tablet compression machine, Tablet Coating machines, Blistering machine, Cartonating machines, Packing Bottle machines, Inspection machine etc.) & its relevant. Ensure minimum time for the breakdown to be achieved 2. To ensure technician & staff deputed at breakdown, preventive & building maintenance works accordingly as per approved shift schedule. 3. To ensure the timely completion of the work orders, purchase orders & purchase requisition & ensure the work measurements are proper and timely bill booking & approval from the Block Head. 4. To involve & support in the modification/ongoing CAPEX as well as projects works for the right implementation of the equipment to ensure right & easy maintenance of the same in future. 5. To ensure the services vendor at site & loading/unloading, fabrication & civil works are carried out as per the GMP norms with safety norms also. AMC if any should be inline as per schedule. 6. To train the people & people management & ensure all have to trained in LMS system as well as applicable OJT in place as per the requirements. 7. To ensure Preventive maintenance & Breakdown maintenance program through SAP system. All records & schedule should be traceable as per SOP. 8. To handle all the stakeholders for their works & timely maintenance solution to each with defined timeline. 9. To coordinate with EHS Department for statuary complies & ensure the safety maintenance. 10. To ensure the critical spares/inventory/hardwares to be available for the maintenance purpose. 24x7 shift management & availability of the manpower’s for the maintenance & rectification works. 11. Implementation of Good Engineering Practices, Good Manufacturing Practices, Data integrity and Good Documentation Practices should be followed & no any noncompliance. 12. To Co-ordinate the internal engineering cross function section like utility, calibration & water system for getting the rectification & timely works completion relevant to process equipment/APU. 13. To prepare the investigation, root cause identification and derive CAPA in case of incident of system failures/out of specification observation and request change control, action item through Track wise (QMS) system. 14. Handling of EDMS, LMS, track wise accordingly & input to be done for the smooth system handling & documents handling accordingly. 15. Co-ordinate for the self-inspection/visit/audit at site & ensure proper walkout for the same while inside the premises/ process equipment area. 16. To handle observations & ensure timely compliances of observations/points same within timeline. 17. To handle the vendor/OEM as per requirements & ensure the GMP compliances accordingly. 18. To ensure all required drawings/layouts of AUTO CAD generated & approved . Status label, record shall be in place & current updated version of the SOP. Drawings/layouts regarding plant equipment & APU system Job Scope Internal Interactions (within the organization) All departments stakeholders External Interactions (outside the organization) External service vendor like fabrication, building maintenance vendors etc. Geographical Scope Any. Financial Accountability (cost/revenue with exclusive authority) To run the maintenance as per defined budget & control the inventory Job Requirements Educational Qualification B.E. Electrical (Preferably). Specific Certification Should know AUTO CAD, PCS system knowledge & Projects skills will add advantages. Skills Good trainer on SOPs, Good mentor to technical staff Experience 10-15 Years.

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. ",

LOCATION: Ahmedabad REPORTS TO: Sr Quality Manager, APAC DIRECT REPORTS: 3 WORKPLACE TYPE: On-site The Quality Manager , India will take the responsibility for leading the India quality functions and personnel safely, responsibly, consistently, and cost-effectively to achieve world-class Quality as a competitive differentiation to support India Business Growth. Provide leadership and guidance to the Internal plant quality Tollers Quality teams to ensure the good implementation of Core GMP practices which relevant to current regulatory standards must to be followed to maintain industry global quality standards and also implement the key components of IPS Pillar in the Quality functions. Develop, coach, and support the site and country Quality team to inspire potential, deliver strong performance, and build great talents. Identify and lead the Quality improvement projects supporting the Quality and Operations groups and be responsible for India Quality MIS reports to India Business Leadership and Regional Quality Core Responsibilities: Optimize the Ingredion India Quality Management Strategy and Roadmap continuously and drive solid implementation in each site, including the Tollers. Coordinate with Regional Quality leadership, Global Pharma Regulatory QMS leadership, Global Regional Quality documentations team to provide guidelines for India quality system to all Ingredion sites to satisfy certification, regulation, corporate, and increasingly complex and diverse customer requirements continuously while improving the agility of the process to meet the business requirements on the premise of current regulations compliance and industry standards. Provide leadership and guidance to the plant operations, manufacturing and quality teams on the execution of the IPS Quality Pillar Ingredion Global Quality Standard including Pharma QMS to deliver continuous quality improvements such as First Pass Compliance (FPC) metrics, customer complaints, and internal/external audit results etc. Be the main contact for Plant Quality managers to escalate Quality issues, assimilate complex information, data, and processes, give insights into the issues, and guide the plant team to move precisely and efficiently. Provide quality improvement suggestions to India Manufacturing leadership and share the quality strategic improvements with India business leadership team on regular/need basis. Meet with the Plant Managers on a regular basis to discuss current issues, and support required, and align priorities as well as employee development strategies. Collaborate with regional/global supplier quality to manage raw material compliance and ensure supplier conformance and prevent quality issues caused by raw materials or goods manufactured by Tollers. Drive and support the investigation of customer complaints timely and reduce the customer complaint rate year by year. Maintain contacting both internal and external networks to identify, introduce, and drive for the implementation of best practices from other locations/businesses related to Pharma excipients Quality and Food Safety management. Lead Quality team to seek CI opportunities and drive innovation culture to improve quality performance, work efficiency, and reduce manufacturing cost continuously. Oversee the EHSS management of Quality function to achieve all EHSS targets and ensure zero recordable incidents continuously. Build great Talents in the Quality team. Flexible to meet the increased demands of the role. Qualified candidates will have: Bachelor s or Master s Degree in Science preferably Pharmacy/Analytical science/Organic Chemistry/Food Science Engineering/Technology or similar Minimum of 10 years of experience in quality assurance management in the Excipient/API/Bulk drugs industry Min 5 years of team management and development experience Working in a global MNC with Pharma GMP and FSSC exposure will be an advantage. Maintain solid knowledge of governmental regulations related to excipients. Deep understanding of CGMP standards of Pharma excipients as per IPEC-PQG GMP training/exposure and or ICH/ USFDA/MHRA/ PICs /EXCiPACT. Good customer interaction experience. Good strategy thinking and strategy development skills on quality. Strong leadership skills and excellent communication and presentation skills. Literate in MS Office software. Good command of English in both written and spoken. High commanding work efficiency with people management, commitment, perseverance under pressure, and ability to deal with challenging situations. Desirable requirements: Working experience in the food industry with an understanding of food regulations, and certification standards such as ISO9001, FSSC22000, BRC, HACCP, etc. will be preferred. Be good at the RCA tools application and could act as an RCA facilitator. B2B business with international customer group working experience. Required behaviors and skills: Interpersonal effectiveness - Establish a constructive and cooperative relationship with colleagues and a climate of openness and trust. Taking ownership - Demonstrate a high level of honesty, integrity, and commitment to one s profession and accept responsibility for the consequences of one s and their team s decisions and actions. Business acumen - Open mind, understanding the critical points of the business, well-balanced Commercial and Operation team s requirements. Timely response, strong problem-solving skills, and good at communication. Growth mindset - Willing to learn and grow through taking more/extra challenges. Relocation Available: Yes, Within Country

DRA Manager Experience- 15+ years Salary Package- 13-17 LPA Must have experience in regulatory Countries dossier preparation and working Should have worked in Injectable Unit location- Baddi Himachal Pradesh

Job Title: Senior Consultant - Oracle Argus Safety Career Level - D2 Introduction to role It s a dynamic and results-oriented environment to work in - but that s why we like it. There are countless opportunities to learn and grow, whether that s exploring new technologies in hackathons, or redefining the roles and work of colleagues, forever. Shape your own path, with support all the way. Diverse minds that work cross-functionally and broadly together. Accountabilities Manage implementation/upgrade/support of Oracle Argus Safety System or other Safety solutions and associated interfaces/integrations Part of technical workstreams (Configuration/Data Migration/Reporting/Upgrade) and provide progress reports, proposals, requirements documentation, and presentations. As Oracle Argus SME, support technical issues associated with Oracle Argus Safety suite and related interfaces Help deliver project and customer success by meeting deadlines, managing expectations, and by delivering good quality solutions Guide team on critical issues or enhancements Participate in design, build and configure applications, acting as the main point of contact Essential Skills/Experience Overall IT experience at least 10 years, with a minimum of 8 years implementation/upgrade/support of Oracle Argus Safety Prior experience in Oracle Argus managed services team and at least couple of implementation/upgrade projects involving configuration/validation/data migration Experience in configuring reporting destinations and rules with advanced conditions Must have implemented continuous improvements Must have trained and mentored junior members Experienced in working with people from different geographies (e.g. USA, Europe etc.) Experience in latest PV regulations by EMA, FDA, MHRA and other regulatory agencies Experience in Regulatory Standards like 21 CFR Part 11, ICH, GxP Solid experience in SQL, PL/SQL Desirable Skills/Experience BE/BTECH in any field or Masters in Computer Applications MCA Readiness to work in UK business hours AstraZeneca is a place where technology meets science to create life-changing medicines. Our work has a direct impact on patients, transforming our ability to develop these medicines. We empower the business to perform at its peak by combining cutting-edge science with leading digital technology platforms and data. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Here you can innovate, take ownership, and explore new solutions with the support you need to thrive. Date Posted 04-Mar-2025 Closing Date 29-Apr-2025

We are hiring for a leading Pharma formulation Group. Oversee 7 pharma plants across India. Responsible for Operations Management , Regulatory Compliance & QA Supply Chain, Process Improvement & Cost Optimization Budgeting & Financial Planning etc Required Candidate profile 20+ years in pharma formulation manufacturing, including 5+ years in leadership Strong leadership, decision-making & problem-solving skills. Experience in handling large-scale manufacturing plants

In-Process Quality Assurance During Production Activity Including Line Clearance And Sampling At Different Stages Of Processing/Packing As Per Pharma API Review of Master Documents such As BMR / BPR Test Batch Monitoring Process Validation Protocol Required Candidate profile Experience with reputed API or Bulk Drugs Unit Co-Ordinate with Plant QA And RA for PDR related activities To Review Specification, MOA And Analytical Data Good Computer And Communication skill Etc

Greetings from BVR People Consulting!! Position: Regulatory Affairs - Formulation Designation: Executive or Asst. Manager Division: Injectable and Solid oral products Qualification: B. Pharm, M. Pharm and M. Sc (FULL TIME) only Years of Experience: 4 to 8 Years CTC range: 5 to 13 LPA. Job Locations: Bangalore ( Electronic City ) No. of Positions: 04 Job Summary: Compilation and submission of the dossier and query responses as per the EU/UK/ANZ /Israel/Belarus and Ukraine regulatory requirements within stipulated timeframe (for Injectable and Solid oral products ). Interaction with CFTs for product specific requirements and to attend product strategy meetings. Review of final data and technical documents received towards dossier compilation from API team, RnD, IP, PV, QA, Commercial, Packaging and Plant team. Compilation of labelling documents as per current EU/UK/ANZ/Israel/Belarus and Ukraine regulatory requirements. eCTD Publishing of dossiers in DocuBridge software. Product life cycle management for approved Europe products i.e. variation, Renewal and sunset exemption filings. Maintain product database, regulatory files, records and reporting systems. Timely updation and maintenance of RIMS database. Preparation and submission of high-quality national translations for National Phase. Post Approval and Pre approval NOTE: We are looking Notice period 01 month or immediate joiner. Interested Candidates should forward their resume to " ganapathi@bvrpc.com" and also Your Current CTC, Excepted CTC and Notice period. Thanks K Ganapathi Mob. No. 9600387468

Sun Pharma Corporate Quality Department Position: Manager (G10) Effective Date: Department: Corporate Quality Location: Bengaluru, Reporting Manager Title: GM - Corporate Quality Classification: Manager - Corporate Quality (Gamma Irradiation) Job Summary: Manager Corporate Quality - Individual Performer Role Responsible for oversight of Gamma Irradiation of Sun Pharma products at third party gamma irradiation sterilization. Essential Job Functions: Should possess sound knowledge of pharmaceutical manufacturing process (Non-sterile & Sterile formulations) & quality assurance regulations and auditing technique. Responsible for the overall supervision of Gamma sterilization site (Third party) used for sterilization of drug product and other components, as required. To monitor receipt and dispatch of consignment of Sun Pharma at Gamma sterilization site. Review and monitoring of irradiation process of the batch and related documentation. Review and monitor of analytical data (Dosimeter Testing) Control and monitor quality systems which enable operations on site to occur in an efficient manner and in compliance with cGMPs. Follow-up for timely closure of QMS documents. Participating in the investigations for Deviations, OOS and Audit findings related to Sun Pharma product/s. Review of changes in gamma sterilization process / major modification at site and timely notification to the management. Supporting in external audits preparations and responding to audit findings of gamma serialization sites Should be able to travel to third party site/s. Basic computer skills (Microsoft word/ Excel/ Power point presentation) and ability to learn and become proficient with appropriate software. Should possess good verbal and written communication skills. Basic Qualification: B. Pharm / MSc Industrial Experience & Knowledge: Minimum work experience of 10-15 Years in formulation & quality systems management operations. Exposure to regulatory agencies audits such as Schedule - M, USFDA, MHRA, ANVISA, TGA, WHO, ISO etc. Knowledge of Track wise/LIMS/SAP is desirable. Ability to work effectively in multicultural matrix organization.

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for Qualification and validation, SOPs and Formats preparation, Training co-ordination and other Engineering GMP activities. Responsible for projects and other activities as assigned. Job Responsibilities Execute all engineering operation as per established ARPL standards and procedures. Reports to Assistant Manager - Engineering and Maintenance at ARPL for day-to-day engineering activities of allotted Job responsibilities. Ensure completion of Scheduled Qualification for the Equipment like Air Handling Units, LAF (Clean air stations), Pass box system, Dust Collectors, De-Dusting booth, Compressed Air System, Nitrogen plant, Water System, Access Control system, Etc., Ensure preparation of protocols and completion of Facility Qualification, IOQ, PQ for modified and newly created area as per the organization requirements. Ensure completion of test like Air velocity and Number of air changes, Class of Air- Non-viable Particle count, Airflow Direction/Pattern & HEPA Filter integrity for Air handling unit qualification. Receipt and review of Qualification Reports and Certificates from qualification service provider. Ensure completion of Scheduled Qualification for the Equipment like Air Handling Units, LAF (Clean air stations), Pass box system, Dust Collectors, De-Dusting booth, Compressed Air System, Nitrogen plant, Water System, Access Control system, Etc., Execute / supervise the engineering department online documentation all time with respect to Equipment Qualification / Re-Qualification / Risk Assessment / Training / Re-Evaluation / Planner / Logbooks. Preparation, updating, Review and archival of Qualification protocols, filter replacement schedules, QSR documents. Prepare Performance Re-qualification protocols and reports in line with the cGMP requirements. Ensuring and maintaining safe workplace at ARPL all time in coordination to EHS personnel. Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements. Execute with quality assurance department for preparation and implementation of engineering department SOPs / Formats / System manual and other engineering documents. Ensuring and maintaining engineering inventory management /upkeep of minimum stock availability for engineering spares. Execute / supervise with the help of contractors on daily basis for follow up and completion of Qualification and other engineering cGMP documentation activities and projects. Coordinating and Attending training sessions on cGMP, Regulatory, SOP trainings, SAP trainings, latest technical & industrial developments related to Engineering. Address and resolve escalated complaints & grievances from user department. Performs all work in accordance with all established regulatory compliance and safety requirements. Notification creation, confirmation and TECO of Preventive Maintenance & Corrective Maintenance work orders in SAP Module. Demonstrate Behaviours that exhibit our organizational values values: Collaboration, Courage, Perseverance and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance program, Global Quality policies and procedures, Safety and Environment policies and HR policies. All other duties as assigned. Job Requirements Education Minimum Diploma Engineering/Bachelors degree in Engineering Knowledge, Skills and Abilities Having Knowledge in Calibration, Thermal Mapping, Qualification and its related Documentation. Having knowledge in QMS documentation. Having knowledge in utilities systems and equipment s. Having knowledge in Preventive maintenance process. Having good interpersonal and communicational skills. Having knowledge of ISPE, ISO and WHO Guidelines for pharmaceutical equipment and area Qualification. Shall have exposure to any of the regulatory audits like USFDA, MHRA, HC, TGA. Etc., Experience Minimum 3 years of experience for bachelor s degree or 5 years of experience for diploma in engineering in pharmaceutical industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Job Title: Lead Consultant-Oracle Argus Safety System Career Level: E Introduction to role: Are you ready to lead the way in digital healthcare? As a Lead Consultant for Oracle Argus Safety System, you will manage the implementation, upgrade, and support of Oracle Argus Safety System and other safety solutions. You will be part of technical workstreams, providing progress reports, proposals, requirements documentation, and presentations. As an Oracle Argus SME, you will offer technical solutions and support for issues related to the Oracle Argus Safety suite and its interfaces. Your role will be crucial in delivering project and customer success by meeting deadlines, managing expectations, and delivering high-quality solutions. You will guide your team on critical issues or enhancements and participate in the design, build, and configuration of applications, acting as the main point of contact. Accountabilities: Manage implementation, upgrade, and support of Oracle Argus Safety System and associated interfaces Provide technical solutions and support for Oracle Argus Safety suite Deliver project success by meeting deadlines and managing expectations Guide team on critical issues or enhancements Participate in design, build, and configure applications Essential Skills/Experience Overall 15+ years of IT experience, with a minimum of 12 years in implementation/upgrade/support of Oracle Argus Safety Suite of applications. Solid experience in managing Argus for large enterprises. Well-established in managing Argus DevOps team and at least a couple of implementation/upgrade projects involving configuration/validation/data migration. Experience in configuring customized import & export profiles as per business requirements. Versatile in implementing complex advanced conditions for various aspects. Must have implemented continuous improvements. Must have trained and mentored junior members. Experienced in working with people from different geographies (e.g., USA, Europe). Experience in latest PV regulations by EMA, FDA, MHRA, and other regulatory agencies. Experience in Regulatory Standards like 21 CFR Part 11, ICH, GxP. Solid experience in SQL, PL/SQL Desirable Skills/Experience: BE/BTECH in any field or equivalent experience in Computer Applications (MCA) Readiness to work in UK business hours When we put unexpected teams in the same room, we spark bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. Thats why we work, on average, a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, our work has a direct impact on patients lives by transforming our ability to develop life-changing medicines. We empower our business to perform at its peak by combining ground breaking science with leading digital technology platforms and data. Join us at a crucial stage of our journey to become a digital and data-led enterprise. With the backing and investment needed to succeed, we are driving cross-company change to disrupt the entire industry. Here, you can innovate, take ownership, and explore new solutions with groundbreaking technology. Ready to make a difference? Apply now to join our team! Date Posted 19-Feb-2025 Closing Date

1. Laboratory Quality Compliance: Ensure QC laboratory operations comply with GLP, GMP, and global regulatory standards. Implement and maintain laboratory quality systems, including data integrity controls and documentation practices. Review and approve laboratory investigations, Out-of-Specification (OOS) and Out-of-Trend (OOT) reports, and Corrective and Preventive Actions (CAPA). 2. Regulatory & Audit Compliance: Prepare and participate in regulatory inspections (USFDA, MHRA, WHO-GMP, etc.), customer audits, and internal audits. Ensure timely implementation of audit observations and compliance commitments. Maintain compliance with ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) principles for data integrity. 3. Documentation & SOP Management: Develop, review, and approve Standard Operating Procedures (SOPs) related to laboratory quality assurance. Oversee the review and approval of analytical reports, Certificates of Analysis (CoAs), and method validation protocols. Ensure proper documentation control and record-keeping for all QC lab activities. 4. Laboratory Investigations & Risk Management: Lead investigations related to laboratory deviations, instrument failures, and non-conformities. Identify root causes and implement corrective and preventive actions (CAPA). Monitor laboratory trends to proactively mitigate risks affecting product quality. 5. Training & Continuous Improvement: Conduct training sessions on GMP, GLP, data integrity, and regulatory updates for QC and QA personnel. Promote continuous improvement initiatives to enhance lab efficiency and compliance. Stay updated on changes in pharmaceutical regulations and implement necessary changes in lab QA practices. 6. Instrument Qualification & Method Validation: Oversee qualification and calibration of analytical instruments (HPLC, GC, FTIR, UV, etc.). Ensure compliance with method validation, verification, and transfer protocols. Collaborate with QC teams to ensure analytical methods are robust and compliant.

About The Role : Job titleBond Analytics Analyst Location:Mumbai, India Corporate title Associate 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.

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.

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities QUALITY ASSURANCE IPQA (Injectable), IPQA (OSD) & QMS / Documentation / Validation and Qualification (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. Injectable Manufacturing Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI OSD Manufacturing / Dispensing / QMS (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification B Sc / M Sc / B. Pharmacy/ M Pharmacy / Diploma Time and Venue : 17th May 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. Preferred candidate profile *Having relevant qualification as mentioned above can attend the scheduled walk-in.

Maintain the microbiology laboratory as per regulatory requirements. Planning and coordination with cross functional team for timely release of the RM,FP, Stability samples. Handling of microbiology related OOS/OOT, Deviation, Lab event. Prepare the response and closure of audit observations. Change control management for revision of SOP s, Validation protocol. Ensure the availability of resources of microbiology laboratory. Ensure the microbiologist certification program of all microbiologist. Implementation of new projects for cost saving, compliance enhancement , work simplification. Having technical knowledge of following major test MLT of OSD products and MLT validation. Disinfectant efficacy test ( Disinfectant Validation) Maintenance of microbial cultures Maintenance of Microbiological media, Growth promotion test. Autoclave validation LAF, Biosafety cabinet, Incubators, pass box validation. Objectionability assessment of identified inhouse isolates. ALCOA++ Good knowledge of various guidelines like ISO14644, HTM 2010, EU Annex 1, 4, WHO, USP chapter 60, 61, 62, 1115, 1116, 1072, 21 CFR regulations Part 210, 211 Environment monitoring program design, risk evaluation, Location selection, Alert and action limit establishment. Purified water system validation. Chemical and microbial analysis of water. 10. Audit experience for FDA, MHRA. ANVISA, TGA etc. 11. Handling of software following but not limited: SLIMS, Lonza Moda, Equisoft, Vitek 2 compact software, High air flow, ICDAS, Trackwise, EDAMS, LMS, e residue , Lab X software, TOC software 12. Hands on experience of major instruments like: Vitek 2 system, TOC analyser, Autoclave, Conductivity meter, Air sampler, Digital Microscope, LAF, Biosafety cabinet.

This role is responsible for Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Competencies critical for the role Scientific/ Technical Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills Academic qualifications and experience required for the role Required Educational Qualification & Relevant experience Desirable - B.Pharm / D.Pharm / BSc. + MBA Essential - Graduates in any discipline Experience: 6 Months. to 2 years as a Medical Rep in a reputed organization. Age should be around 28 years ",

Role & responsibilities Candidate having experience in to OSD pharmaceuticals from QC/QA/Production/F&D/ADL

Role & responsibilities 1. Production Planning and Scheduling 2. Compliance and Documentation 3. Supervision of Manufacturing Processes 4. Personnel Management and Training 5. Quality and In-Process Control 7. Process Optimization and Yield Improvement 8. Regulatory and Customer Audits Preferred candidate profile Education: B.Pharm / M.Pharm / B.Sc with strong domain knowledge in OSD manufacturing. Experience: 15+ years in pharmaceutical production, with at least 5 years in a managerial role overseeing OSD manufacturing. Regulatory Exposure: Hands-on experience in facing WHO-GMP, and other inspections. Skills: Leadership, decision-making, analytical thinking, team management, and strong knowledge of GMP and QMS.

About The Role Job TitleSA LocationMumbai / Pune Skill- End to end KYC, Periodic Review, AML, and Due Diligence Shift Timings:APAC , EMEA , NAM Roles & Responsibilities This role will include the understanding and implementation of the KYC lifecycle. He/she would be responsible for opening, amending, reviewing and exiting clients according to established policies and procedures, and also review clients transactions to detect and report either proposed or completed unusual transactions. Key responsibilities include: Performing the due diligence on new Clients, requesting the KYC information, documentation, review and verification of received documentation and making an analytical risk assessment for new Clients Thoroughly and succinctly document the research and analysis related to the financial activity and related entities of Clients Escalate issues to client and internal managers to bring issues to their attention promptly Independently handle clients and client calls"“ establish self as a valued partner Help knowledge management endeavor by sharing process knowledge and best practices within the teams Communicate effectively and efficiently with relevant internal and external parties to obtain KYC documents Have a thorough understanding of the clients business and related parties to monitor clients activities for unusual transactions Perform further investigation on identified suspicious client and clients transactions and report to KYC/AML compliance officer Qualification and Skills Bachelors Degree (B.Com, BBA, BBM, BCA) / Masters Degree (M.Com, MBA, PGDM). 2 to 4 years of experience and knowledge of KYC, AML, and Due Diligence Should be able to understand, manage and calculate risks Should be good with logical and quantitative abilities