161 Fda Jobs - Page 6

Systems Verification Engineer (5-10 Yrs of exp.) Qualifications Create clear product design documentation such as concept diagrams, specifications, requirements, test plans, and V&V reports perform test/verification for NPI or sustaining of innovative electromechanical products Establish and maintain traceability between requirements, and testing Develop test protocols for the purposes of design verification and validation Execute testing and generate associated reports Oversee the building and testing of prototypes, including internal team and external vendor management Performs hands-on system testing and troubleshooting of technical issues Design benchtop tests, fixtures, and regression test plans to prove out concepts, functionality, and safety Required Qualification Bachelors degree in electrical, Computer, Biotechnology, Systems Engineering, or other related field. 5+ years experience in electromechanical device and system design/verification for new product development Direct hands-on systems engineering experience, preferably with medical device electronic systems or other complex electronic hardware. Technical competencies: Experience developing software driven electromechanical devices in a regulated environment. Broad engineering expertise across all engineering disciplines. Direct experience in requirements authoring, decomposition, analysis, traceability, and verification. Direct experience with complex electronics systems/component design. Experience in writing detailed product Verification/qualification plans and reports. Preferred Qualifications Familiarity with all phases of the product development lifecycle. Familiarity with HW / Embedded SW development, integration, and verification Familiarity with scripting and data analysis experience using Python, MATLAB, or equivalent programming languages. Experience working with 3D design tool, Creo , Solid works , Fusion 3Detc. Experience with low fidelity prototyping 3d Printing, PCB design, PCB reworks etc. Experience in the medical device industry, ISO 13845 , FDA quality management system Enjoy working effectively as part of a small, fast-paced, cross-functional, cross-cultural integrated team.

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs tasks of building regulatory dossiers of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.You will be expected to collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for? Life Sciences Regulatory Services Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Agility for quick learning Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Master of Pharmacy

Quality Control Dept, ensuring Timely testing & quality check of Raw Materials and Finished Products. Analysis on equipment like HPLC, FTIR, GC etc, all other Q.C. related matters Required Candidate profile Experience in handling HPLC, FTIR, GC etc, for 3 to 7 yrs, Experience in Quality Control dept. of Pharma Company. FDA Approval Required. Perks and benefits Apply with Salary Drawn & Expected Salary

Quality Control (QC) Officer ensures products meet quality standards and regulatory requirements by performing tests, Analyzing results, and maintaining records, ensuring safe and effective medications. Must Experience in FDA Approved Company.

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. About The Role : The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

Job : System Verification Engineer Location: Bengaluru Experience: 8 + Years Qualifications Create clear product design documentation such as concept diagrams, specifications, requirements, test plans, and V&V reports perform test/verification for NPI or sustaining of innovative electromechanical products Establish and maintain traceability between requirements, and testing Develop test protocols for the purposes of design verification and validation Execute testing and generate associated reports Oversee the building and testing of prototypes, including internal team and external vendor management Performs hands-on system testing and troubleshooting of technical issues Design benchtop tests, fixtures, and regression test plans to prove out concepts, functionality, and safety Required Qualification Bachelors degree in electrical, Computer, Biotechnology, Systems Engineering, or other related field. 8+ years experience in electromechanical device and system design/verification for new product development Direct hands-on systems engineering experience, preferably with medical device electronic systems or other complex electronic hardware. Technical competencies: Experience developing software driven electromechanical devices in a regulated environment. Broad engineering expertise across all engineering disciplines. Direct experience in requirements authoring, decomposition, analysis, traceability, and verification. Direct experience with complex electronics systems/component design. Experience in writing detailed product Verification/qualification plans and reports. Experience with integrated systems verification, including developing hardware verification test plans and verification test reports. Previous experience with change management Hands-on experience building, testing, and troubleshooting prototype devices Ability to manage and prioritize workload, multi-task and manage a diverse mix of issues, responsibilities, and challenge. Preferred Qualifications Familiarity with all phases of the product development lifecycle. Familiarity with HW / Embedded SW development, integration, and verification Familiarity with scripting and data analysis experience using Python, MATLAB, or equivalent programming languages. Experience working with 3D design tool, Creo , Solid works , Fusion 3Detc. Experience with low fidelity prototyping 3d Printing, PCB design, PCB reworks etc. Experience in the medical device industry, ISO 13845 , FDA quality management system Enjoy working effectively as part of a small, fast-paced, cross-functional, cross-cultural integrated team.

Job Title: Regulatory Publishing Specialist SUMMARY Responsible for formatting and publishing electronic documents, and building of regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs and JNDAs and their amendments and supplements in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, JP, ICH, etc). JOB RESPONSIBILITIES: • Electronically format and publish submission components in line with regional specifications. • Compile and validate electronic submissions in publishing software (Lorenz Docubridge) • Accountable for dispatching finalized submissions through the appropriate regulatory authority portal and archiving in Veeva. • Responsible for overseeing routine submissions, including the creation of submissions in Veeva. • Provides guidance on good documentation and submission practices. • Assist with developing and maintaining Regulatory document processing and Regulatory submission. publishing standards and procedures. • Identifies and communicates regulatory system enhancement needs or technical issues. • Assists with regulatory inspection activities. • Collaborates with vendors who support Regulatory submission document related tasks. • Provides support and backup to management as needed. JOB REQUIREMENTS: Education • Bachelors Degree Experience • Minimum of 2 years experience with Regulatory Operations • Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). • Strong knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required. • Familiarity with Veeva Vault & Lorenz Docubridge would be advantageous. Requirements • Full-time, office-based position (5 days per week) • Working standard regional hours

Designation - Executive QCQA Company: Sharangdhar Pharmaceutical Pvt Ltd, Pune (www.sharangdhar.com) Gender - Male/ Female Age- 25-35 Experience Min 2 Years and above Education - B. Pharm, M. Pharm, ( FDA Approval.) Salary Depend on interview and Knowledge and Experience. (No salary Bar for Right candidate) Required Talent: Candidate must having good communication skill in Marathi and English , Knowledge of Computer , Smart & Enthusiastic, Right attitude, Quick learner , Go-get it done approach. Salary Depend on interview and Knowledge and experience. Job profile, role, and responsibility details- 1) In-process analysis of product (new plant) bulk density ( dry mix) moisture (granules) 2) In-process analysis of tablets as per scheduled batches friability hardness, DT. 3) Finish analysis of products as per packaging scheduled batches tablets and granular products. 4) Calibration of instruments ( IR moistures balance PH meter daily ), (weighing balance weekly) 5) Packaging and Production line clearance 6) FDA related Working Contact Person Name & Number: Swati Mane 8149072022

- Audit preparation - SOP making & updating - Preparation of NPD & update as per progress - Periodic training on topics - Handling customer complaints - Maintaining rules & regulation as per advanced regulatory norms - Ensure all product Quality . Required Candidate profile - B.Sc/M.Sc full time degree - 1+ years experience in Pharma company

Job description: The ideal candidate will be responsible for managing regulations like RoHS, REACH and SDS. This role involves ensuring compliance with regulatory requirements, accurately documenting material data, and facilitating communication with suppliers and customers. Responsibilities: • Responsible for component BOM analysis • Identifying and approving alternate part replacements for obsolescence and lead time issues • Knowledge in Electronic Components / Cost Analysis/ Electronic Component Datasheet study for Form Fit Function comparison • Apply problem-solving skills to define issues, identify root causes, qualify and implement corrective actions in a timely manner • Must Know preparation of document, and communicate project status as required both verbally and in written form • Responsible for selection, quality and reliability of parts. • Support design engineers, commodity specialists in electrical and electronic components • Comprehensive knowledge of compliance regulations for wireless products, electronics, automotive. Preferred knowledge of RoHS, REACH, Prop65,PFAS, POP, TSCA, WEEE and Conflict Minerals validations for electronic component compliance (CMRT/EMRT). • Knowledge of ECHA SCIP database compliance • Maintain regulatory compliance in environmental and hazardous waste management Preferred knowledge of relevant national and international standards and processes for compliance as applicable to Electrical and Electronic compliance systems, Responsible for signing the EU Declaration of Conformity • Understanding of ArenaProduct Data Management Tools & ECR (Engineering Change Request) Processes Required Skills: • Obsolescence management best practices • Good knowledge on electronic components and component selection • Electronic Component characterization and validation • Engineering change management • Problem solving, and analytical skills • Strong customer focus and ability to work effectively with a wide variety of people • Need to be self-motivated and team player • Computer competency in Word, Excel, Power Point, Access and databases • Strong communication skills, including ability to speak and write convincingly. Qualifications: Bachelors degree in engineering, Environmental Science, Material Science, Chemistry, or related field. Minimum 2 - 5 years of experience with In-depth knowledge of regulatory requirements and standards such as the European Union's End-of-Life Vehicle (ELV) Directive, REACH, RoHS, Conflict of Minerals, and other relevant environmental and safety regulations. Strong attention to detail and accuracy in data entry and documentation. Strong project management skills with the ability to work cross-functionally. Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal teams and external stakeholders. Proficiency in using IMDS software and other relevant tools for material data management. Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment. Proven track record of driving process improvements and achieving results.

Job purpose The Manager/ Sr. Manager of Pharmacovigilance will navigate the complex landscape of clinical safety, on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development and state of the art pharmacovigilance post approval. This role reports directly to the Chief Medical Officer at Ocugen. Duties and responsibilities As the Manager/ Sr. Manager of Pharmacovigilance, Clinical Quality, Safety and Pharmacovigilance, you will be tasked with applying sound judgment for the analysis and interpretation of complex clinical safety data for signal detection and initiation of safety risk management activities including safety specification, PV planning and risk minimization/mitigation. The role will require the identification and implementation of all clinical standard-operating procedures in order to ensure GCP compliance. The role serves as the senior clinical safety representative in the cross-functional development teams. You will be responsible for setting Ocugens clinical safety strategy for these global projects. The role identifies potential challenges, risks and roadblocks associated with the global safety domain and works as a leader in developing solutions to address these. The role ensures that the medical and process standards delivered at Ocugen are in alignment with following safety objectives expected of manufacturers by internal and external stakeholders including regulators, governmental agencies, payors, physicians, patients, and the general public. Responsibilities include overseeing the safety signal detection and medical signal evaluation process and analysis of aggregate safety data and the production of key company documents such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports) and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion. Providing a safety role in facilitating reviews done by internal and external DMCs (Data Monitoring Committees) and in unblinding clinical data to protect ongoing study participants and complete timely communications to Health Authorities Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards. Participate actively in the Continuous Improvement Process (CIP) targeted at continuous improvements of quality of processes, methods, and communication. Review and contribute to safety relevant SOP and improvement of safety relevant SOPs. Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety. Ensures regulatory agency inspection findings and internal audit findings relating to products of responsibility are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function. Set safety strategy based on strong product knowledge and biologicals safety experience that allows for successful IND (Investigational New Drug)/NDA (New Drug Application) filings and initiation of first in human studies. Oversees all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports. Oversees development of core safety information for new products Provides major contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk in Ocugen’s studies. Gives guidance on various medical, product-related and process-related matters in a complex medical and scientific environment including many interface departments and functions. Complies with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities: Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization or from occupational exposure Promoting the safe and effective use of medicinal products through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public Contributing to the protection of patients and public health The role identifies tools necessary to facilitate safety surveillance and clinical safety assessment and to implement necessary risk management initiatives. Provides input into clinical development, due diligence, regulatory and issue management activities from a clinical safety perspective and represents the position of GCSP in internal governance committees and in discussions with Health Authorities Qualifications Eight(8) to Thirteen (13) years pharmaceutical/biotechnology industry experience, of which at least six (6) should be in a safety role, with broad overview of all aspects of a PV system and specific experience in signal detection and risk management. Experience and success in addressing and managing complex safety issues in the pre-approval and post-approval environment including interfacing with external regulatory bodies (written and verbal interactions. e.g. External Audits, Ad Coms, CHMP Oral Explanations, etc.) Knowledge of scientific data relevant to own products and across therapeutic area, including the competitive environment and the disease state Strong understanding of data capture, data management and statistical methods for the preparation and analysis of safety data in clinical trials Detail oriented, exceptional documentation practices, technical writing, and verbal communication skills. Ability to convey complex concepts through clear and concise messages. Excellent problem-solving skills, contingency planning, and risk-mitigation strategies Ability to navigate and be successful in a fast-paced, highly matrixed work environment. Working conditions This position operates in an office setting and may include 20% of travel from time to time. Physical requirements This is a largely sedentary role.

Description As a biotechnology trailblazer, we're dedicated to discovering, developing, and commercializing cutting-edge gene and cell therapies, and biologics to transform global healthcare. If you're ready to be part of a team that's shaping the future of medicine and making a profound impact on patient lives worldwide, join Ocugen and well rewrite the future of healthcare together. Job purpose The Principal Biostatistician will be responsible for providing statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product. The individual should be able to ensure application of appropriate statistical methods and generation of accurate and reproducible results through error- free statistical programming in SAS, R and/or other programming languages. This individual will work closely with the Director of Biostatistics, the rest of the team at Ocugen, and CROs to execute the statistical and data needs. Duties and responsibilities CDISC Standards : Proficiency in CDISC standards (SDTM & ADaM) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs). Study Lead: Experience juggling multiple projects simultaneously is preferred. Submission Documents : You'll create and review submission documents and electronic case report forms (eCRTs). Collaboration: Effective communication with cross-functional teams and clients is crucial. Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review. Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays. Provides tabular and written summaries of analyses and statistical methodology. Ensures accurate programming of SAS clinical data extracts and data displays. Develops programming specifications, including analysis datasets and tables/listings/figures. Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements. Ensures the integration of data across studies in support of CSS/CSE. Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies. Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents). Interfaces with CRO to ensure data and statistical reporting is secure and timely. Proactively identifies risks, developing and implementing mitigation plans as applicable. Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs. May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts. May assist in developing policies and procedures (SOPs). Additional tasks and projects as requested. Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports. If applicable, develops and provides department training for applications and standard tools developed by the department functions group. Qualifications MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field Experience: At least 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry (with a bachelor's degree) or 6 years with a master's degree or above. Expertise: Familiarity with statistical principles, CDISC data, and standards. Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus SAS, (Base, Stat, Macro, graph); SAS certificates a plus Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Excellent communication and collaboration skills with a team-oriented approach. Demonstrated ability to identify and resolve issues and effectively manage timelines. This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs. This is a largely sedentary role.

Res. 4 for the Prod. Oprs. within a pharmaceutical company, ensuring all Mfg. processes comply with stringent regulatory stds. set by the TPA & the FDA, often managing a team & holding Res. 4 QC, Docs., & compliance throughout the production cycle. Required Candidate profile BSc or related science field with Ext. Exp. Of 3-5 Yrs. in Pharma Mfg., ideally with a focus on sterile prod. or complex drug delivery systems. Thorough u/s of TPA & FDA regulations & compliance reqs.

• Responsible for Defining and Implementation of Quality Management system and Quality Assurance processes across OSD and CMO/ CRO locations. • Ensuring compliance with all cGMP requirements in line with global and Indian regulatory requirements • Handling all Regulatory audits, Client Audits, Internal Audits • Responsible for Qualification /Audit of CxP Vendors and CxP service providers • Responsible for GxP Training • Responsible for providing all documentation and other necesary support for Regulatory for product registrations and life cycle management • Responsible for providing all documentation and other necessary support for Business / Marketing, Customers • Responsible for management of Deviations, OOS, Complaints, Changes, Qualifications, Validations • Responsible for Licenses, Certifications and compliance (Indian FDA / CDSCO)

Role & responsibilities 1. All Licenses, Labels, Products, PM etc. to comply with FSSAI, LMA, PCB regulations for all 3 plants. Represent CF on regulatory forums. Legal notices closure. Regulatory document filing, tracking and completion for all 3 plants 2. Tracking, CAPA, Complaint resolution communication to relevant stakeholders, Timely resolution/closure of quality related customer complaints 3. Giving regulatory inputs for all NPD/NPI for Label, Ingredients and PM compliance. 100% compliance on all Labels 4. Creating and conducting various Food safety trainings according to BRC requirement to all employees. Food Regulatory training module preparation and training for quality and other relevant stake-holders. 5. Complete at least 3 regulatory related trainings. Preferred candidate profile 5-10 years in Quality Assurance, with 2+ years in a managerial role . Degree in Food Tech, Microbiology, Engineering, or related field . Strong knowledge of QMS, audits, risk management, and compliance . Regulatory & Compliance Process Management Knowledge on Licenses, Factory Compliances Perks and benefits Gratuity Group Mediclaim Policy Group Accidental Policy Performance based Incentives

Job purpose The Clinical Database Programmer is a key member of Clinical Biometrics team. This individual will be responsible for providing database services including database design, creation, and validation to collect data for research, development, and/or marketed product. The individual should be able to ensure accurate data collection from electronic systems through error-free programming. This individual will work closely with the Biostatistics and Data Management team as well as other Ocugen team members to execute the statistical and data needs of the clinical studies. Duties and responsibilities Collaborates with other team members to define database requirements . Involves in programming, validation of standard and study-specific electronic Case Report Forms (eCRFs). Troubleshoots and resolves database issues timely. Designs, implements and maintaining databases or collaborates on implementation and collection of data supporting research protocols. Provides database consultation for research programs. Collaborates on development of database specifications, data management plans, data transfer specifications, data review specifications and/or data quality review plan specifications Develops edit checks, QC, and validation reports to ensure quality data. Provides input to project timelines and ensures that project timelines for database deliverables are met. Ensures that project tasks are completed with acceptable quality. Ensuring data integrity ,security and availability. Perform database back ups and recovery. Attends team meetings. Additional tasks and projects as requested.

*Process Management: Expertise in overseeing production processes, ensuring efficiency, compliance, and quality standards. *Production Planning & Scheduling: Ability to develop production plans that align with customer demand and business goals, optimizing resource utilization. *Leadership & Team Management: Proven track record in leading cross-functional teams, fostering collaboration, and driving high-performance cultures. *Regulatory Knowledge: Deep understanding of industry standards (GMP, FDA, EMA, ICH) and the ability to ensure compliance across all levels of production. *Quality Assurance: Strong focus on maintaining product quality, managing deviations, and implementing corrective and preventive actions (CAPA). Problem-Solving & Troubleshooting: Skilled at identifying issues in the manufacturing process, analyzing root causes, and implementing solutions quickly. *Process Optimization: Familiarity with Lean Manufacturing, Six Sigma, and other methodologies to improve operational efficiency and reduce costs. Equipment Maintenance & Management: Proficient in overseeing the upkeep, calibration, and validation of manufacturing equipment. *Safety & Compliance: In-depth knowledge of occupational health and safety standards, ensuring safe working environments.

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

About The Role :: Job Title: Regulatory Control Analyst Corporate Title: AVP Location:Bangalore, India Role Description The candidate for the AFC Centre of Excellence for KYC is supporting CB and IB KYC escalations to AFC, collaborating with the relevant Business stakeholders, Client Lifecycle Management and other AFC functions. Primary focus of the reviewer would be to ensure they review and approve the risk factor highlighted by CLM team as part of NCA/EDR/PRs AFC KYC COE Implement a dedicated Centre(s) of Excellence for the AFC element of the KYC file review, allowing customers to be reviewed once in review cycle. Below are some of the key principals . Achieve economies of scale through the creation of one functional team with sophisticated risk managers, under one global leader who is accountable for the AFC KYC file review and sign-off process. Ensure fulfilment of local regulations and regulatory expectations in an efficient, risk focused manner. Ensure sufficient resources to create and effectively maintain a follow the sun KYC file review aligned with ACO availability. Seek opportunities to geographically co-locate the CoE with respective 1LoD counterparties (i.e. align with the 1LoD Target Operating Model) to stimulate cooperation and strengthen the relationship 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) 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 Review and approve client escalations for Remediation, Regular Review, New Product Extensions and Event Driven Reviews within the agreedSLAs Ensure the generated client risk rating is in line withexpectations & procedures. Assess the risk factors identified through the due diligence provided by client lifecycle management (CLM) Apply subject matter expertise judgment as to relevance and/or materiality of Escalation triggers; i.e., can the overall assessment bedefended Engage with appropriate BLAFC specialist team where further escalation is required e.g., local BLAFC, AFBC, Sanctions, BIUetc.. Liaise with CLM to obtain additional information or request ACO to conduct additional research whererequired Ensure outcome and rational is clearly documented within the KYC systems and / or escalated for furtherguidance Ensure that KYC reviews undertaken are in line with the KOPs guidelines andprocesses Contributing to the wider globalKYCCentre of Excellence programme, identifying best practices Deciding on new or existing clients that are escalated or deciding to escalate further to Governance Forums for review. Defining and implementing strategic TOM in-line with local/regional/global standards and change programmes. In long run be the deputy to your lead and help new team members in coming up the learning curve. Work with country lead to ensure the daily/weekly reporting is precise and where possible streamline the data by providing suggestions. Your skills and experience Skills: Ability to identify and manage financial crime risks arising from regular reviews, event driven reviews, new client adoptions and new productextensions Strong communication, organizational, and interpersonal skills with the confidence to engage and advise professionally and persuasively with stakeholders. Proven analytical skills, problem solving ability, and a control mindset paired with meticulous attention to detail. Able to raise sensitive or potentially contentious issues in a constructive manner to reach appropriate solutions. Deadline driven with the ability to multi-task and work in a fast-paced environment. Ability to handle time-sensitive projects while focusing on the quality of work delivered. Self-motivated and proactive team player who takes ownership of assignments, thrives in a teamwork-oriented environment, and works well under pressure. Ability to work with various stakeholders across all 1LoD and 2Lod and manage expectations, without impacting the quality output. Experience: Must be a graduate with any stream with at least 6-7 years experience in AFC or a related control related function within an international organization/bank in the Financial Services industry with extensive experience with the KYC process. People having a degree or diploma in AML/KYC will be preferred. A strong track record in risk and regulatory matters, ideally including: Good understanding of AFC risks and typologies in order to identify areas or instances of potential AFC risks and to address them appropriately. Experience of relevant regulations/laws and related circulars Financial Crime function expertise and should be considered a Subject Matter Expert (SME) in the Financial Crime area on relevant laws and regulations. Should be flexible with respect to work timings. Should be comfortable in working on MS Office tools using word and excel. How we'll support you Training and development to help you excel in your career. 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.

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 Description Medical Product Compliance Engineer Dexian is seeking a full-time Medical Product Compliance Engineer reporting to the Sr. Engineering Manager of Codes and Standards. Collaborate with both the New Product Development (NPD) and Sustaining teams to ensure that products developed and maintained comply with national and international standards. What you will be doing Provide technical review of product to ensure alignment with national and international standards. Assist product development teams in applying and understanding design standards and directives. Resolve compliance issues by working with various engineering disciplines such as electrical, mechanical, and software. Help maintain and sustain the product technical files for the production life of the products. Submit required compliance reports to safety agencies and review 3rd party technical files and documentation. Review user documentation to ensure that required warnings, labels and symbols are properly documented as required by standards. What you bring Minimum of 5 years' experience in the medical device industry. BS Degree in Electrical or Mechanical Engineering or equivalent experience. Minimum of 5 years' experience in Compliance Engineering equivalent in working with Notified Bodies and standards preferred. Experience working in the codes and standards capacity at a Medical Device manufacturer Knowledge of medical safety standards preferred: IEC/EN/UL 60601-1, lEC 60601-1-11, and 60601-1-8. Demonstrated ability to assess the application of Codes & Standards to new product designs in order to obtain & maintain the agency certifications specified by the design requirements (e.g. UL, lEC, VDE, CSA). Experience in performing IEC 60601-X tests and test setups preferred. Experience or understanding of ISO 14971, FDA and EU requirements preferred. Experience or understanding of EMC preferred. Excellent written and oral communication skills. Self-motivated with high performance standards.

Role & responsibilities: Prepare and manage regulatory submissions (e.g., Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), marketing authorization submissions). Ensure clinical trials are conducted in compliance with regulatory requirements, including Good Clinical Practice (GCP), ICH guidelines, and local regulations. Track regulatory timelines and manage submission deadlines for new drug applications, clinical trials, and so on. Preparation and review of clinical study reports along with preparation of Bio summary/summary tables, BTIF and other regulatory documents with the study data. Adhering to GCP to meet regulatory requirements, Verification of deviations from the Protocol, SOPs, GCP and other applicable requirements and taking preventive action and corrective action to prevent recurrence. Preparation of audit reports and suitable corrective and preventive action plans. To have experience in the Ethics Committee related activities. To liaison with Local Drug Authorities (DCGI/CDSCO) for regulatory approvals of Test Licenses, Amendments, for conducting BA/BE clinical studies in India. Timely notification to DCGI/CDSCO for study related updates Communicate with regulatory agencies to clarify requirements and resolve issues related to clinical trial approvals and submissions. Manage responses to regulatory queries and facilitate interactions between the client and regulatory bodies. To search literature on healthy population to support BA/BE NOC application To liaise CBN for regulatory approvals for conducting clinical studies in India. To coordinate with global regulatory authorities for regulatory strategic for various products and services Proactive co-ordination of all the necessary activities required regulatory submission. Preferred candidate profile: Education : Bachelor's degree in life sciences, pharmacy, or related field (Masters or advanced degree preferred). Experience : 5+ years of experience in regulatory affairs within a CRO or pharmaceutical/biotech industry, with at least 2 years in a managerial role. Knowledge : In-depth knowledge of global regulatory guidelines (FDA, EMA, ICH), clinical trial regulations, and submission processes. Interested applicants can apply with their updated profile or Can send to email to hr@qpsbioserve.com

Hi, I am Nirmal from the Pharma Vertical of Masadir HR Services, an International Recruitment Firm. We have been retained by a professionally managed organisation to recruit Food Technologist Beverages for them. The job location is Kohara, Ludhiana . Kindly find below the job description: • Develop and optimize formulations for a range of tea-based and functional beverages. • Work with natural sweeteners, flavoring agents, and stabilizers to create sugar-free and health- focused beverages. • Conduct research on new ingredients, processing techniques, and market trends to develop innovative products. • Perform product stability studies, sensory evaluations, and shelf-life assessments. • Ensure compliance with food safety regulations (FSSAI, FDA, etc.) and maintain proper documentation. • Collaborate with the production, quality assurance, and sales teams to optimize product performance and scalability. • Work closely with suppliers and vendors to source high-quality raw materials. • Maintain detailed records of experiments, trials, and process optimizations. If you are interested or know any suitable candidates kindly share your updated resume with me through Whatsapp 8608205815 . Looking forward to hearing from you soon. Thank you! Have a great day! Regards Nirmal Marimuthu Associate | Global Talent Acquisition Operations M: + 918608205815 E: nirmal.m@masadirhr.com

Creation/modification of process flows within the Manufacturing/Service Departments. Remediate Manufacturing, DHF, DMR Documents of new and legacy products to current organization standards and policies. Perform gap assessment and conduct remediation of documents with stakeholder inputs. Development and maintenance Manufacturing/Service Work Instructions and related documents. Creation/modification of fixtures, tooling, equipment and systems to support operations. IQ, OQ, and PQ of fixtures, tooling, and equipment. Identify, investigate, and resolve operational issues to improve First Pass Yield and reduce waste. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions. Support corrective and preventive actions in manufacturing using formal problem-solving tools and documentation. Medical Device Experience with knowledge of FDA 510 K, IS013485, ISO 14971 standards preferred. Must be able to work well as a member of a team with the ability to adapt quickly to changes and work efficiently in a fast-paced environment. Experience with statistical software packages (Minitab is a plus), SAP, windchill, onePLM etc. Experience with Quality Systems and process controls in the medical device industry is desirable. Knowledge and working application of FDA, cGMP, ANSI/ISO/ASQC requirements. Knowledge and working application of technical part drawings and GD&T principles. Demonstrated application of engineering principles on individual/small projects and ability to work with cross functional teams to successfully implement quality improvement and cost reduction initiatives. Demonstrated strong analytical problem solving Root Cause Investigations, CAPA, Six Sigma, continuous improvement projects. Ability to multi-task and methodically lead/manage projects. Location: Chennai Required Skillset: Gap Assessment and Remediation for DMR, Class 2 and 3 device

Role & responsibilities Formulate Color Cosmetics: Develop and create formulations for a variety of color cosmetic products, including but not limited to foundations, lipsticks, mascaras, blushes, eyeshadows, and primers. Ingredient Selection & Sourcing: Research and select high-quality ingredients that meet both functional and aesthetic requirements while ensuring the formulation aligns with brand standards. Stability and Safety Testing: Conduct stability testing to ensure product shelf life and performance. Ensure all formulations comply with industry safety regulations and standards. Collaboration: Work closely with R&D, Marketing, and Regulatory teams to ensure formulations are in line with brand objectives, aesthetic direction, and consumer preferences. Product Evaluation: Participate in product testing and sensory evaluations to ensure the final product meets texture, color payoff, durability, and overall consumer experience standards. Trend Research & Innovation: Stay informed on industry trends, new ingredients, and emerging technologies within the cosmetics industry to continuously improve and innovate formulations. Documentation & Reporting: Maintain detailed records of formulations, processes, and testing results. Prepare reports and presentations for internal stakeholders. Preferred candidate profile: Education: Bachelors degree in Cosmetic Science, Chemistry, or a related field. Experience: 1-2 years of experience formulating color cosmetics (such as makeup products like foundations, lipsticks, eyeshadows, etc.) in a cosmetic or personal care industry. Technical Skills: Proficiency in formulation techniques and understanding of cosmetic ingredient functionality. Experience with formulation software and data management is a plus. Creativity & Attention to Detail: Strong ability to create innovative formulations with a keen eye for detail, texture, and color. Knowledge of Regulatory Standards: Familiarity with cosmetic regulations and safety standards (e.g., FDA, EU Cosmetic Regulation) for color cosmetics. Team Player: Ability to work effectively in a collaborative environment and manage multiple tasks with a positive attitude. Strong Communication Skills: Ability to communicate technical information clearly and effectively to non-technical teams. Why Join us ? Opportunity to contribute to innovative and exciting product launches in the fast-growing color cosmetics category. Work in a creative, fast-paced environment with a supportive team. Competitive compensation and benefits package.