203 Usfda Jobs - Page 7

Positions 1) Technology Transfer Scientist (FRD) / 2- 6 years of experience 2) Documentation Lead (FRD)/ 3- 8 years of experience 3) Formulation Development Scientist/ 2- 10 years of experience 4) FRD Injectables / 2- 8 years of experience

Walkin 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 requirement is matching your current job profile, kindly walk-in with your latest resume. Role & responsibilities QUALITY ASSURANCE IPQA (Injectable) - (Officer / Senior Officer / Executive) Experience - 02 to 08 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. QUALITY ASSURANCE (QMS / Compliance / Documentation/ Validation & Qualification/OSD) (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 08 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. Engineering: Instrumentation / QMS (Senior Executive / Executive / Senior Officer) Experience - 03 to 09 Years Qualification BE / B tech with relevant functional experience in Calibration / Instrumentation / QMS activities Injectable - Manufacturing & Packing & Visual Inspection (Senior Executive / Executive / Senior Officer / Officer / Associate) Experience - 01 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma with relevant functional experience in injectable manufacturing/ Aseptic area operations / Packing / Visual inspection / QMS activities OSD Manufacturing & Packing ( Executive / Senior Officer / Officer / Associate) Experience - 01 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / Diploma with relevant functional experience in OSD manufacturing and Packing operations / QMS activities Time and Venue : 29th June 2024, 09:30 Hrs to 15:00 Hrs ______________________________________________________ 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. Perks and benefits

Role & responsibilities Job description Ensure that a company's products comply with the regulations of the regions. Keep up to date with national and international legislation, guidelines and customer practices Respond to queries from Centre for Veterinary Medicines (CVM). Collect, collate and evaluate scientific data from FR&D, AR&D and DQA. Develop and write clear arguments and explanations for new product licences and licence renewals at R&D site. Prepare submissions of licence variations and renewals to strict deadlines as per CVM. Monitor and set timelines for licence variations and renewal approvals Advise scientists (AR&D, FR&D, Pkg.-R&D) on regulatory requirements. Provide strategic advice to senior management throughout the development of a new product Review company practices and provide advice on changes to systems if any. Liaise with manager, and make presentations to, regulatory authorities, if any. Negotiate with regulatory authorities for marketing authorisation Take part in the development of marketing concepts and approve packaging and advertising before a product's release. Prepare the CTD sections of the dossier and ensure timely filing as informed by the functional head and Head -R&D. Review the data and check for its alignment and compliance from regulatory point of view as per CVM. Ensure the regulatory filing grid as shared by Functional head and Head-R&D is met on timely way and in complete regulatory compliance. Collaborate with FR&D, AR&D, Pkg-R&D on regular basis and together ensure the timely filing of products.

Job Title: Manager/Senior Manager QA Regulatory Affairs Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 8-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: M.Sc in Biotechnology, Microbiology, or a related field Bachelor’s or Master’s in Pharmacy Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager/Senior Manager – QA Regulatory Affairs , you will play a pivotal role in ensuring that our vaccine , injectable , and sterile pharmaceutical products meet global regulatory requirements and quality assurance (QA) standards. You will oversee regulatory strategies, regulatory audits, and the management of Quality Management Systems (QMS) to ensure our products comply with industry-specific standards. This role demands extensive experience in regulatory affairs , particularly within the vaccine and sterile manufacturing domains, including handling CDSCO , EU GMP audits, and other regulatory matters. Key Responsibilities: Regulatory Strategy & Compliance: Develop and execute regulatory strategies to ensure compliance with global standards for vaccine , injectable , and sterile products . Maintain a strong understanding of global regulatory requirements, including FDA , EMA , WHO , and local regulations like CDSCO to guide product approvals and market entry. Ensure alignment of product development and manufacturing processes with Good Manufacturing Practices (GMP) , Good Laboratory Practices (GLP) , and other relevant GxP standards. Audit & Inspection Management: Coordinate and manage regulatory audits (e.g., CDSCO , EU GMP ) for vaccine , injectable , and sterile products, ensuring full compliance and readiness across all departments. Lead the preparation for regulatory inspections related to CDSCO and EU GMP , working closely with relevant teams to ensure effective corrective actions and continuous compliance. Manage responses to audit findings and ensure the implementation of corrective actions in line with industry standards. Quality Management System (QMS): Oversee the implementation and management of the Quality Management System (QMS) to ensure product quality and regulatory compliance. Lead the development and review of Standard Operating Procedures (SOPs) , ensuring that they align with current regulatory requirements for vaccine and sterile product manufacturing. Monitor and ensure compliance with the QMS framework across all departments to maintain consistent product quality. Regulatory Submissions & Documentation: Oversee the preparation, compilation, and submission of regulatory dossiers and eCTD documents to regulatory bodies (e.g., FDA , EMA , CDSCO ). Ensure that all required documentation and records are properly maintained and comply with regulatory standards, ensuring smooth regulatory approvals for vaccine , injectable , and sterile products . Risk Assessment & Mitigation: Conduct regulatory risk assessments to identify potential issues related to product development, manufacturing, and compliance. Develop and implement risk mitigation strategies to ensure uninterrupted production and compliance with regulatory standards. Cross-Functional Collaboration: Collaborate with internal teams such as R&D, Production, and Quality Control to ensure regulatory compliance throughout the product lifecycle, from development to post-market surveillance. Provide regulatory guidance and training to cross-functional teams, ensuring awareness of applicable QA practices and regulatory requirements . Corrective and Preventive Actions (CAPA): Lead the implementation of Corrective and Preventive Actions (CAPA) to address audit findings, non-conformities, and deviations, ensuring continuous improvement in compliance and quality practices. Key Skills and Competencies: Expert Knowledge of Regulatory Guidelines : Extensive knowledge of global regulatory requirements (e.g., FDA , EMA , WHO ) with specific expertise in vaccines , injectables , and sterile product manufacturing . Regulatory Submissions & Documentation Expertise : Strong experience in preparing regulatory dossiers and eCTD submissions in compliance with regulatory standards for vaccines and sterile products . Audit & Inspection Management : Hands-on experience managing CDSCO and EU GMP audits, including preparing for inspections, addressing findings, and implementing corrective actions. Quality Management System (QMS) Oversight : Expertise in implementing and maintaining QMS in compliance with GxP , FDA , EU , and WHO guidelines, ensuring product quality and regulatory compliance. Risk Management & Mitigation : Proven ability to conduct regulatory risk assessments and implement mitigation strategies to prevent non-compliance and product issues. Strong Leadership & Project Management : Demonstrated ability to lead cross-functional teams, manage multiple projects, and meet regulatory deadlines while ensuring alignment with quality and regulatory expectations. Corrective & Preventive Action (CAPA) Implementation : Experience in managing CAPA processes, addressing non-compliance issues, and ensuring the effective resolution of audit findings and regulatory observations. Excellent Communication Skills : Strong verbal and written communication skills, with the ability to liaise with internal teams, regulatory bodies, and external stakeholders in a professional and clear manner. About GreenSignal Bio Pharma Pvt Ltd: GreenSignal Bio Pharma Pvt Ltd is a leading pharmaceutical company specializing in vaccine , injectable , and sterile products . Our commitment to quality, compliance, and innovation has made us a trusted partner in the healthcare industry. We are looking for experienced professionals to contribute to advancing our vaccine and biologics portfolio while adhering to the highest regulatory standards. For more information, please visit: www.gsbpl.com How to Apply: Interested candidates can apply via email at: hr@gsbpl.com For inquiries, please contact us at: +91 8778926365 Join Our Team and make a significant impact in the vaccine and sterile product industries

Role & responsibilities: Responsible for all Deficiency management of US Market Skill to compile & review ANDAs & their Deficiency responses. Experience of working on IND / 505(b)(2) / Innovations projects for US market. Good analytical and formulation understandings of various dosage forms. Sound knowledge of Regulatory Science and Regulatory Intelligence. Thorough understanding of US ANDAs / GDUFA / ICH guidance. To provide support to cross functional teams to ensure quality and timely submission of the NDA/ANDA/Def. responses. Preferred candidate profile : Must have experience of IRA US market more than 2 years. Critical thinking ability, problem solving skill, regulatory writing skill, and communication skills are very much desired Ready to work at Ahmedabad location. Work from Office only.

Labour and Employment Law Legal Team Associate Manager / Manager Description About Entity: Corporate Functions"including Human Resources, Finance, Legal, Marketing Communications, and Workplace Solutions-- powers Accenture's people across industries and functions to keep our business leading in the New. Join the heart and soul of Accenture, partnering with our extraordinary people to bring innovation into every organization. Job description: Labour & Employment Counsel Associate Manager Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, Accenture offers Strategy and Consulting, Technology and Operations services and Accenture Song"all powered by the world's largest network of Advanced Technology and Intelligent Operations centres. Accenture India has operations in 14 cities across India and have more than 300k employees spread across these locations. Requirement: We are looking for 2 lawyer for position of Associate Manager (equivalent to a Deputy Manager in industry parlance) in the Employment Law (India) Legal Group Reporting will be to Senior Manager / Associate Director [Legal] Employment Law which is a part of Operations, Regulatory and Ethics (CORE) Legal, supports a broad portfolio and supports the Delivery Centres, in end-to-end operations. Internal clients range from Employee Relations, HR, Recruitment, Workplace, Global Asset Protection (GAP), Marketing and Communication (Marcom), and Government Relations. Role Description: This role is broad and could involve providing advice on various facets of legal and employment areas and demands an understanding of Indian labour laws, laws relating to investigations (misconduct, POSH and others), and court proceedings etc. Focus for the current position is as follows: Role Description: Advisory Services: Provide legal guidance on employment-related issues in India, including hiring practices, employment contracts, misconduct, discrimination, harassment, employee benefits, termination procedures etc. Proactively assess and mitigate employment legal risks. Employment Disputes and Litigation: Manage employment-related disputes, claims, and litigation in tribunals and courts, including wrongful termination, discrimination claims, and wage disputes. Collaborate with external legal counsel to strategize and achieve optimal outcomes. Legal Drafting: Prepare written statements and responses to claims, conduct comprehensive legal research to support case strategies, and stay abreast of recent case laws and legal precedents in labour and employment law. Sexual Harassment Law: Provide advice on matters related to the Prevention of Sexual Harassment (POSH) Act. Policy review: Collaborate with stakeholders to develop, review, and implement employment policies and procedures that comply with local laws and align with the organization's values. Regulatory Monitoring: Monitor changes in employment laws and regulations, assess their impact on the organization, and recommend proactive measures to ensure compliance and mitigate potential risks. Labour Compliance: Ensure adherence to labour laws and regulations, including the Shops and Establishments Act. Sexual Harassment Law: Provide advice on matters related to the Prevention of Sexual Harassment (POSH) Act. Key Skills: Review employee matters, analyse and asses possible and suggest mitigations measures. Court experience and proficiency in drafting legal documents and court submissions Strong legal research and analytical skills with in-depth knowledge of Indian labour laws and regulations Clear communication and interpersonal skills High attention to detail and exceptional organizational skills. Qualifications Education and Experience Requirements Required LLB 6 + years relevant work experience

Role & responsibilities Senior executiveIssue of BPR's, Validations,Qualifications,Change control, Handling Deviations Preferred candidate profile should be from API background Perks and benefits Best In industry

Overview Shure is a global leader in professional audio electronics with a history of product innovation spanning over 90 years. The Shure Hyderabad location has been operational since June 2019. W e are looking for talented professionals who have experience in the SEZ compliance area. This position is a part of the Finance team at Shure India. Responsibilities Well versed with SEZ Rules , Regulations and customs regulation Should have exposure to de-bonding, Imports, DTA, Temporarily Removal of goods and other allied matters in SEZ Well versed of SEZ online portal Exposure to all compliances related to SEZ and STPI units viz., MPR, QPR, APR, Softex, Endorsement of Invoices, DSPF etc. Collation of details from relevant teams for preparation of returns/ submissions/ replies to SEZ STPI authorities for various units across India Responsible for representations/liaising with SEZ/STPI Authorities for various matters and obtain necessary approvals Assistance in audits Liasioning with Bankers for clearing the BOE’s Ensuring the invoices are in compliance with the SEZ norms Maintaining the documentation Maintaining the Fixed Asset Register Qualifications Bachelor’s Degree in Commerce or MBA with experience of working in multi national companies in similar role. Experience is minimum 3Years. WHO WE ARE. Shure’s mission is to be the most trusted audio brand worldwide – and for nearly a century, our Core Values have aligned us to be just that. Founded in 1925, we are a leading global manufacturer of audio equipment known for quality, reliability, and durability. We engineer microphones, headphones, wireless audio systems, conferencing systems, and more. And quality doesn’t stop at our products. Our talented teams strive for perfection and innovate every chance they get. We offer an Associate-first culture, flexible work arrangements, and opportunity for all. Shure is headquartered in United States. We have more than 35 regional sales offices, engineering hubs, and manufacturing facilities throughout the Americas, EMEA, and Asia. THE MIX MATTERS Don’t check off every box in the job requirements? No problem! We recognize that every professional journey is unique and are committed to providing an equitable candidate experience for all prospective Shure Associates. If you’re excited about this role, believe you’ve got the skills to be successful, and share our passion for creating an inclusive, diverse, equitable, and accessible work environment, then apply! #LI-HYBRID

Green Earth Exim India Pvt. Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Prepare, review, and maintain Standard Operating Procedures, Batch Manufacturing Records (BMR), and Batch Packaging Records (BPR), Process Validation Protocol, Process Validation Report, Stability and Specifications and Standard Testing Procedure.

Expertise in ROW market, understanding nuances in regulatory demands across regions in-depth knowledge of FDA Guidelines to ensure compliance in documentation and submissions. Proficiency in handling technical documents to facilitate accurate and timely submissions Proven ability to review regulatory documents and submissions effectively, ensuring their accuracy and compliance Strong analytical skills to assess regulatory data and provide critical insights for decision-making Experience in dossier preparation, organizing comprehensive documents for regulatory authorities Attention to detail to meticulously handle documentation and regulatory records Excellent communication skills to liaise with regulatory agencies and internal departments Preparation of registration dossiers as pe regulatory guidelines Preparation of renewal application as per renewal guidelines Facilitate query response raised by regulatory authority and customers Preparation and submission of Safety, Quality & administrative variations as per variation guidelines

Lead Quality Assurance operations, ensuring compliance with GxP and continuous improvement. Oversee Quality Systems to maintain compliance with regulatory requirements and procedures. Ensure timely execution of Quality Assurance activities, including Change Controls, CAPA, Deviations, OOS, OOT, and Market Complaints. Represent QA during regulatory/customer audits, track compliance plans, and implement corrective actions. Monitor the effectiveness of CAPA programs and ensure accurate implementation. Facilitate batch review and release per regulatory requirements. Investigate and resolve non-conformances, ensuring appropriate corrective and preventive actions. Ensure execution of Annual Product Reviews and escalate recommendations to senior management. Maintain adherence to safety, data integrity, and ethical conduct policies. Oversee in-process Quality Assurance (IPQA) for compliance with shop floor activities. Review and approve key documents across Production, Warehouse, Quality Control, Engineering, R&D, and EHS. Participate in cross-functional meetings, ensuring alignment on quality, compliance, and process improvements. Support sterility assurance programs, media fills, and aseptic process monitoring. Coordinate internal audits and ensure timely resolution of observations. Monitor and enhance aseptic practices in the manufacturing environment. Ensure timely investigation and resolution of customer and market complaints. Provide batch disposition decisions and approve release documentation. Ensure timely submission of required documents to regulatory and cross-functional teams. Prepare and review protocols, procedures, and QMS elements to sustain compliance. Identify training needs for QA team members and conduct required training programs. Lead quality discussions in periodic review meetings, supporting compliance and process improvements. Track and monitor timely closure of deviations, root cause investigations, and CAPA. Ensure timely resolution of queries from customers and third-party review teams. Promote continuous quality improvements through effective cross-functional collaboration. Promptly report and escalate non-conformances or critical quality issues for assessment.

" 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. RD 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. ",

As a Regulatory Affairs Specialist, you will research, write, and compile technical documents for regulatory submissions in the USA, Canada, and Europe, while ensuring compliance with relevant guidelines. Youll assist in setting up manufacturing processes, handle regulatory authority inquiries, and manage device-related incidents. Ahmedabad 2 to 5 years experience Apply to this position Wellnest is looking for passionate individuals to join our team and help us achieve our goal of transforming the industry. Job responsibilities Research, write, analyze, and edit technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada and Europe. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. Help set up the correct manufacturing processes and suggest changes in manufacturing model whenever applicable. Assist in preparing responses to regulatory authorities questions within assigned timelines. Stay abreast of regulatory procedures and changes in regulatory climate. Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in a timely manner. Handle recalls and field actions, if required. Review and create product labels and review promotional material for compliance with applicable regulations and technical standards Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance Other duties as assigned. Job requirements Must have the knowledge and experience with manufacturing licensing, CDSCO, ISO standards Should be able to single-handedly setup and lead the entire regulatory process for a startup (research to documentation to audits) Experience with successfully getting EU-CE and USFDA approvals for medical devices is a huge plus Someone who has worked with setting up a regulatory team for a medical device organization will get priority Get in touch Apply Now! Fill out the application form and our team will get back to you shortly. Name Phone Number Email Address Current Company Current CTC Total Experience (in yrs)

Company: Strides Pharma Department: IPQA Profile: - Executive Office Locations: Alathur Qualification – B. Pharmacy/ M. Pharmacy Experience – 2 to 6 years (Must have exposure to OSD) Job Description: • To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. • QA overview for clean room behaviour and aseptic activity. • Review of batch processing records. • Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. • Review of documents of respective areas and logbooks for adequacy and completeness. • QA overview for receipt of material from warehouse to production. • IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. • Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. • Preparation & Review of process validation protocols and reports. • Executing the validation/revalidation activity in the absence of authorized person. • Any job activity assigned by HOD • Responsible for regulatory audits with exposure equivalent to WHO Geneva PQ/USFDA Competencies: • Execute IPQA Excellence by setting clear benchmarks. • Smart Thinker and displays smart/ tactical moves & mental agility. • Is open and flexible when faced with changing circumstances and finds ways and means of doing things and not get struck with the past. • Comes up with ideas which are different and can be used commercially, profitably and growth. • Support and guide subordinates by giving appropriate examples & feedback. Encourage team to come up with new ideas. • Proposes solution which has elements of sustainability.

Company: Strides Pharma Department: IPQA Profile: - Executive Office Locations: KRSG Plant, Bangalore Qualification – B. Pharmacy/ M. Pharmacy Experience – 2 to 6 years (Must have exposure to OSD) Job Description: • To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. • QA overview for clean room behaviour and aseptic activity. • Review of batch processing records. • Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. • Review of documents of respective areas and logbooks for adequacy and completeness. • QA overview for receipt of material from warehouse to production. • IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. • Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. • Preparation & Review of process validation protocols and reports. • Executing the validation/revalidation activity in the absence of authorized person. • Any job activity assigned by HOD • Responsible for regulatory audits with exposure equivalent to WHO Geneva PQ/USFDA Competencies: • Execute IPQA Excellence by setting clear benchmarks. • Smart Thinker and displays smart/ tactical moves & mental agility. • Is open and flexible when faced with changing circumstances and finds ways and means of doing things and not get struck with the past. • Comes up with ideas which are different and can be used commercially, profitably and growth. • Support and guide subordinates by giving appropriate examples & feedback. Encourage team to come up with new ideas. • Proposes solution which has elements of sustainability.

Job Role : Sr.Manager Production (OSD) Job Location : Poanta Sahib Job Function : Formulations (OSD) Education : Graduate in Pharmacy (B. Pharm) Experience : 15 to 18 yrs Job Summary 1. Manufacturing and Packaging operations of Oral Solid Formulation. 2. Documentation operations of General Solid Oral Manufacturing and Packaging Department. 3. Ensure that Investigations, CAPA, Batch Records preparation completion schedule is prepared, tracked and, execution of schedule as per plan. 4. Review and production approval of documents like: I. Commercial product, stability batches, exhibit batches, characterization Batches - Master Batch manufacturing record and Master Batch Packaging record. II. Risk assessment, process validation protocol, Incident and Investigation report, CAPA Reports. III. Protocols & reports. V. Internal Quality Audit, Regulatory Quality Audit Compliance. VI. Change control, Standard Operating Procedure, and other documents including amendments. 5. Provide leadership and expertise to ensure achievement of production with respect to Quality outputs and commercial demands. 6. To ensuring that there are appropriate manufacturing and technical processes and procedures in place for the production. 7. To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. The production records are evaluated and signed by a designated person. 8. In coordination with Quality head monitor the factor that may affect product Quality compliance of GMP, retention of records. 9. To approve the instructions relating to production operations, including the in-process controls, and to ensure their strict implementation. 10. To check the maintenance of the department, premises and equipment. To ensure that the appropriate process validations and calibrations of control 1. equipment are performed and recorded and the reports made available. 2. To ensure that the required initial and continuing training of production personnel for SOP, cGMP, personal hygiene are carried out and adapted according to need. 3. Optimization of the resources like men, materials and machines in manufacturing and packing area. 4. Ensure efficient collaboration and co-ordination between relevant departments like Warehouse, Engineering, PPIC, Quality Control, Quality Assurance, procurement and management. Supporting Compliance of internal quality/corporate quality/regulatory audit. Planning & execution of various activities viz. Gap Analysis, enhancement, SOPs, protocols and reports etc. To perform Risk Assessment with respect to investigations, internal / regulatory observation response, market complaints and for system improvements etc. 8. To co-ordinate with FDD, PDD (R & D) /MSTG for execution of trial/exhibit /Process validation batches and trouble shooting. 9. Procurement of New Suitable Equipment's required for process as per cGMP requirements. 10. Identify and implement improvements to the production process, yield. 11. To ensure protection of the product from contamination. And monitor quality standards of products. 12. Shall delegate authority to deputed deputies with satisfactory level of qualification and experience. 13. Coach and develop direct and indirect reporters through on going, example based performance feedback, annual performance reviews and provision of training and development opportunities. 14. Assure all time readiness department for regulatory agency inspections/internal audits and appropriate implementation of corrective actions regarding observations made by the agencies and internal audit teams. 15. Shall participate in Internal Quality Audit. 16. Responsible for ensuring market complaints, failures deviations are investigated and corrective and preventive actions are implemented as per set timeline. 17. Performs all work in support of our Corporate Values of pride- Humility, Integrity, passion and with accountability and diligence. Perform all work in accordance with all established regulatory and compliance and EHS requirements. Reporting Manager Comments

Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Associate Qualifications: BCom Years of Experience: 1 to 3 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model – powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeAbility to effectively and efficiently conduct the process of screening individuals, entities, or transactions against lists of sanctioned or restricted parties. Sanctions screening involves using specialized software, understanding relevant regulations, and maintaining a proactive approach to mitigate the risk of engaging with sanctioned entities. What are we looking for? Collaboration and interpersonal skills Problem-solving skills Strong analytical skills Numerical ability Ability to meet deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications BCom

Recruiter Details Mohaneswara Reddy https://www.linkedin.com/in/mohaneswarareddy Role & responsibilities Strict adherence to safety, health and environment. Carry out Manufacturing activities by following and monitoring standard operating procedure (SOP) and current Good Manufacturing Practice (cGMP). To ensure effective implementation of RFT and Data integrity policy. Maintenance, upkeep of the department, premises and equipment. To maintain discipline in the section To protect product and material against spillage and deterioration Monitoring and Safely operating the machine as per SOP, with minimum rejection & maximum output. Improvement, continuous review and up gradation of existing SOPs & work systems and to ensure their strict implementation. To track execution of cleaning activity of non-product contact/indirect product contact surfaces Discussion of the day-to-day work with Section Head. To Co-ordination with other sections and departments. Check and monitor for cleanliness and environmental conditions of area w.r.t. temperature, relative humidity, differential pressure, microbial control, fly control and AHU handling (SCADA). To ensure that all materials and finished products are stored under the appropriate conditions as per specification and in an orderly fashion to permit batch segregation and stock rotation. To perform study as per various Study Protocol in areas. To perform activities such as Cleaning, Line Clearance, Operation, PPM and Calibration of equipment and area as per roles and responsibilities. To cooperate for investigation of deviations, OOS, OOT and complaints observed as per Standard Procedure. To perform timely entries of data and completeness of Batch Manufacturing Record, Checklist, Logs and Protocols on Issued Documents. To perform activities such as Calibration, Sanitization, Maintenance of DM Store, Inprocess store and Cleaned equipment Area. Maintain and monitor inventory required in Department and Scrap the damaged inventory. To transfer Inprocess and Finished goods to Inprocess store. Checking raw material is dispensed for manufacturing of batches and Issuance of batches for processing of next stage and also ensure Preparatory set up work prior to start of manufacturing activity. To monitor and maintain correct Status labelling of containers, equipments, area and materials. Identification, classification, finding, quarantine and destruction of rejects generated during manufacturing process. Calibration of equipment, instruments and weighing balances and PPM as per schedule and maintaining records of the same. To Operate SAP system, PRAMAAN (E-Log), LMS, Trackwise and Cipdox system based on roles and rights Provided in the application. To involve in the training conducted in the section (Scheduled training, Training on changes, Miscellaneous) and also as per the nominations given by Section Head/ Department Head. Participating in Process Validation and Cleaning Validation in co-ordination with Quality Assurance. Preferred candidate profile Candidate with a B. Pharm full time degree along with minimum 7 years of experience in softgel manufacturing

Pfizer Healthcare India Private Limited - Visakhapatnam Walk - in interviews for Freshers Junior Associates - Manufacturing Dates & Venue: Written Assessment & Personal interview on Wednesday, 26th Mar 2025 at 9:00 AM Interview address : Government Polytechnic College, Pharmacy Block, Kancharapalem, Visakhapatnam - 530007 Eligibility Criteria: Diploma Pharmacy only (2024 Pass out) & Pass Percentage 60% in Academic & No backlogs. Job Description Operate production equipment such as injectable machines, sterile machines, parenteral machines, formulation machines, filling machines, capping machines, compounding machines, washing machines, sealing machines, Visual inspection & packing machines. Monitor and control the production process to ensure quality products are produced within specified parameters. Maintain accurate records of production data and perform routine maintenance tasks on equipment as required. Collaborate with other team members to resolve issues and improve overall efficiency. Ensure adherence to Good Manufacturing Practices (GMP) guidelines.

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications. Perks and benefits: Mention available facilities and benefits the company is offering with this job.

Working with Us Challenging Meaningful Life-changing Those aren't words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here, uniquely interesting work happens every day, in every department From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity Take your career farther than you thought possible Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives Read more: careers bms com/working-with-us Collaborate with clinical stakeholders to understand their reporting and analytics needs aligned with study protocols May Translate requirements into comprehensive reporting development specifications, in collaboration with Report end users Support for utilizing existing standard reports whenever possible and to suggest solutions as needed for any new additional requirements Develop reports and analytics visualizations according to specified requirements, ensuring a "first time right" approach Test developed reports, document results, and provide peer review support as needed Adhere to documentation and process compliance, notifying management of any noncompliance Knowledge of regulatory requirements such as ICH, FDA 21 CFR part 11 and GxP Work cohesively with team members, embracing feedback and suggestions Keeping up to date with new reporting tools, techniques, and industry trends to enhance skills and knowledge Plan for your day, make a to-do list and prioritize your tasks based on clinical study needs and consult Line managers for support Embrace feedback and suggestions, continuously working to enhance knowledge and professionalism in the work environment Participate in departmental/organizational activities/initiatives at the site level to build contacts across the organization, fostering collaboration for the benefit of patients Flexible to work with global stakeholders across different time zones while ensuring business continuity as needed If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues On-site Protocol Responsibilities BMS has a diverse occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential, site-by-design, field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms com Visit careers bms com/ eeo -accessibility to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff, customers, patients, and communities As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers bms com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations

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.

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

" 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. ",