271 Process Validation Jobs - Page 7

Must have experience of Vaccine/Biological Industry IPQA activity in Production BMR Review/ Line clearance Process Validation Media fill Validation Gowning Qualification/Visual inspector Qualification Trend/APQR preparation Investigation & Evaluation Dossier document compilation Job Location: Kadi, Gujarat ( Bus facility available from Ahmedabad, Kalol & Kadi) Note: Immediate joiners will be preferred first

Exemed Pharmaceuticals is looking for QA Sr Executive – Luna to join our dynamic team and embark on a rewarding career journey You will also be responsible for identifying and resolving quality-related issues and ensuring that the company's products and services meet the requirements of customers Conduct regular quality audits to identify and resolve quality-related issues Develop and maintain quality metrics to track performance and identify areas for improvement Manage the documentation process for quality assurance procedures, including the creation and maintenance of standard operating procedures (SOPs)

Education : Minimum B.Sc./M.Sc./B. Tech with computer operating Knowledge. Key skills: Knowledge of Medical Device Industries, ISO, CE & Indian Medical device Rules 2017(Drug department). Responsibility : Deep knowledge of ISO 13485 and ability to make necessary modifications as per requirements. Knowledge of EUMDR, Indian MDR and applicable government regulations. Responsible for regulatory affairs activities to assist in regulatory submission. Responsible for Risk Management as per ISO 14971. Responsible for customer complaints and in-house nonconformity. To conduct and maintain records of Internal audits and MRM including quality objectives. To prepare process validation protocol and perform the validation activity. To analyze the process data as per ISO 13485. To ensure that test methods are strictly adhered to, test reports are forwarded to the designated authority.

Role & responsibilities New Product Development. Integrate automation system with exisiting manufacturing equipments and infrastructure. Conduct testing and validation of automation systems to ensure functionality and performance meet requirements. Provide technical support for troubleshooting mechanical issues and implementing corrective actions. Optimize automation process to improve efficiency, reduse waste and minimize downtime. Develop and maintain documentation related to NPD, Including specification, drawings and operating procedures. Collaborate with vendors and suppliers to select and procure FTG, SPM Components & equipments. Management of facilities like equipments & spares, coordinate with maintenance team to improve the quality/productivity. Provide cost saving in direct and indirect material, coordinate with R&D for implementation of cost saving ideas - ECR to EPI, wastage elimination reduction. To ensure safety of operators, workplace, facilities, fatigue reduction/elimination, improvements / SIAT to done. Improve quality by resolving chronic/major issues by process/design change, regular process audit. Preferred candidate profile DME/B.E/B.Tech - Mechanical with 5+ years of experience in manufacturing enginnering. System Knowledge: QMS, OSHA, EMS, EnMS Data Management, Process Complience of ISO standards.

Role & responsibilities Process validations Special Purpose Machines specification making & concept finalization with CFT inputs. Online trouble shooting related to tooling & process. Low-cost automation implementation Process Lay outing SPM installation & commissioning. SPM Validation. Hands on experience on machine validations . Knowledge & hands on experience related to process costing Knowledge of IATF/ TQM/ Industrial Engg. / Line balancing Knowledge of pneumatics & hydraulics Knowledge on error Proofing implementation. Hands on experience for new lines setup Hands On experience for PFMEA . Customer audits experience. Customer PPAP experience. Preferred candidate profile B.E/B.Tech - Mechanical Engineering with 6 to 8 years of experience in autocomponent industry.

Role & responsibilities Validation & Qualification Oversight Prepare and maintain Validation Master Plans (VMP) in alignment with corporate and regulatory guidelines. Review and approve qualification documentation including URS, DQ, IQ, OQ, PQ, RQ , ensuring completeness and compliance. Supervise execution activities and guide the team during validation and qualification stages. Oversee and review Performance Qualification (PQ) , Requalification , interim and summary reports , and addenda . Documentation & SOP Management Develop and review validation protocols , SOPs, and QA documentation related to equipment, facility, and utility qualification. Review and ensure compliance of SOPs from other departments that impact validation and qualification processes. Ensure proper documentation control, including version management and approval routing. Project Management & Execution Ensure timely completion of validation activities in alignment with project milestones and regulatory timelines. Review layouts and engineering drawings for facilities, utilities, and equipment to ensure compliance and suitability for intended use. Maintain and oversee revalidation schedules in accordance with change control and periodic review programs. Deviation & Change Control Handling Investigate and document validation-related deviations and change controls , recommending and implementing appropriate corrective and preventive actions (CAPAs) . Collaborate with cross-functional teams to resolve validation and qualification issues proactively. Training & Team Development Mentor and train QA validation team members on current practices, regulatory expectations, and internal standards. Conduct knowledge-sharing sessions to build team capability in equipment, facility, and utility validation . Compliance & Continuous Improvement Ensure cGMP compliance in all validation and qualification activities, maintaining a validated state at all times. Continuously evaluate and improve validation systems, practices, and documentation to meet evolving regulatory requirements. Preferred candidate profile Bachelors or Master’s degree in Pharmacy with 8–12 years of relevant experience in QA Validation within a regulated injectable manufacturing facility . Proven expertise in equipment / facility / utility qualification , process validation , and cleaning validation . Strong knowledge of regulatory guidelines : cGMP, 21 CFR Part 11, EU Annex 1, WHO TRS, ICH Q8-Q10. Experience in deviation handling , change control , and validation risk assessments . Ability to read and interpret engineering drawings , layouts, and P&IDs. Hands-on experience with documentation systems and quality management systems (QMS).

To Prepare new SOPs as per required, revise existing SOPs based on periodic updation and as per internal & external audit recommendation after that review and implemented SOPs of Production department. To Carryout process validation and cleaning validation in coordination with R&D, QC and QA. To review the acceptance criteria is fulfilled for new molecules as well as modify process for existing molecules, also ensure all validation protocols and reports are reviewed accordingly. To Ensure the compliance for cGMP and Safety in production area to work in safe work environment and ensure the subordinate are working in safe condition. To ensure plant facility is always ready for facing internal and external audit. Review audit report and to provide CAPA for all observation and implementation of CAPA. To monitor and review temperature, Humidity, and differential pressure records in clean area (Level-II & III). To ensure that the required documents are maintained as per cGMP and USFDA guidelines and to verify filled documents BMR/BPR/BCR etc. To ensure adherence to SOPs and cGMP during manufacturing operation in the production department. To raise online incident, deviation (Planned/ Unplanned) and change control for new products and existing products etc. and to be closed after completion of activity along with preparation of supporting documents for closing. To investigate (OOS/ Incident/ Deviation) the failure of batches as and make a report with conclusion of root cause/ Probable root cause and CAPA. To initiate CAPA for evaluation and effectiveness of CAPA. After completion of activity CAPA to be closed along with preparation of supporting documents. To prepare and review BMR/BPR/BCR etc. for new products and enhance batch size of existing products as per process given by R&D with related to plant. To revise BMR/BCR etc. according to internal/external audit, validation report and RA recommendation. To prepare equipment and process mapping details, change summary, Equipment comparison, Process comparison, Risk assessment, Errata, Quality comparison/ equivalency and process flow diagram. To update list of authorised personnel entry into production area, Organogram, List of SOPs for revision, List of change control/ CAPA/ Deviation (Planned/ Unplanned)/ OOS/ Incident/ Errata/ Product details/ Equipment details/ Risk assessment for timely closing before due date. To prepare and review Protocols and Reports for area qualification & requalification, Calculator validation, Excel sheet validation for calculation of weighing balance accuracy and precision check log and Intermediate re-analysis for re-test period etc. To generate the online training in AIMS software through issuing/requesting related consulting with concern department. Functional and Cross functional training to be imparted to new joined employee for job specific and job oriented and existing employee as per training need identification and BMR/BCR/LCS etc. To prepare Limit calculation sheet (LCS) for new products of API for cleaning of equipments and existing product in case enhance batch size and change in API equipment based on validation recommendation. Co-ordinate with QA, QC, R&D, Warehouse, Engineering, ADL, and RA department for related to documents preparation, if any failure of products and compliance. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To take training online in AIMS software.

EXECUTIVE-SALES PPC/-/1306251 Marketing Coimbatore Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 2 years ShareApply Basic Section No. Of Openings 1 Designation Grade Executive M10 Freshers/Experience Experience Employee Bonus Two Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Chemical India Private Limited Department Marketing Country India State Tamil Nadu Region Coimbatore Branch Coimbatore Skills Skill Market and Competitive Analysis Minimum Qualification Any Graduate BSc MBA CERTIFICATION No data available Working Language Tamil English About The Role Candidate taken for the replacement of Mr.N.Sabariyar who is looking in market cirlce-COI02 of Cbe branch.Candiate should be minimum 2-Years experience in marketing and having good knowledge in system.

Trainee - chemist PPC/T-C/1299164 Warehouse - Quality Madhavaram Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 1 - 1 years ShareApply Basic Section No. Of Openings 2 Designation Grade Executive M10 Freshers/Experience Freshers Employee Bonus Two Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Chemical India Private Limited Department Warehouse - Quality Country India State Tamil Nadu Region Madhavaram Branch Madhavaram Skills Skill Quality Assurance Minimum Qualification BSc CERTIFICATION No data available Working Language English Hindi About The Role To Sample and testing the incoming Raw material, finished goods & Packing material. To inspect in process batch and to test for batch release. To inspect product vessels and provide clearance for production. To develop testing SOP and test methods. To coordinate during external and internal audi ti ng.

sales executive-Ppe PPC/S/1322122 Business Development Coimbatore Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 0 - 1 years ShareApply Basic Section No. Of Openings 1 Designation Grade Executive M10 Freshers/Experience Experience Employee Bonus Regular Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Logistics Private Limited Department Business Development Country India State Tamil Nadu Region Coimbatore Branch Coimbatore Skills Skill Customer Acquisition Commuincation Sales & Marketing Skills Minimum Qualification Graduate CERTIFICATION No data available Working Language Tamil About The Role Generating and managing sales, Maintaining client relationship Meeting sales Targets ,Identifying and developing new business opportunities, negotiating deals ,Maintaining customer satisfaction

Executive - Sales Quality PPC/E-SQ/1309588 Sales Head Office Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 1 - 3 years ShareApply Basic Section No. Of Openings 1 Designation Grade Executive M10 Freshers/Experience Experience Employee Bonus One Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Chemical India Private Limited Department Sales Country India State Tamil Nadu Region Chennai Branch Head Office Skills Skill Minimum Qualification No data available CERTIFICATION No data available Working Language No data available About The Role Key Responsibilities 1) Monitor Sales Executive Visits & Interactions ? Daily basis Evaluate and assess live tracking of sales executives visit by punchin/out live records and yesterday records to maintain reports to ensure adherence to company standards, compliance guidelines, and meets the targets. (TimeLive recording monitoring Morning 1 hr, Afternoon30 mins and 1 hr evening, Total=2.5 hrs Pan India) ? Conduct regular reviews of sales visit and key in as per customer visit report (CVR) to ensure quality, accuracy, and consistency. (Time120 mins) ? Provide feedback to management on their performance and provide inputs to improve skills and effectiveness. 2) Quality Audits & Reporting ? Conduct routine quality audits of punchin/out report and CRM records. ? Track and monitor daily and weekly based report on key performance indicators (KPIs) for sales team performance such as conversion rates, visiting all the customers in given period of time (CCV) customer visit report against the visit target (PJP VS CVR), and adherence to sales protocols. ? To call the SEs to get the inputs if SE not meeting the target visits, punch-in after 10.30 am and punch-out before 5 pm (Time1 hr) ? Prepare and present regular reports on quality trends, highlighting areas for improvement and suggesting actionable recommendations. 3) Process Improvement ? Collaborate with the Sales team to develop and implement corrective actions and process improvements. ? Work with Sales leadership to standardise and optimise best practices in the sales process. ? Documenting all quality processes, findings, and improvement initiatives are well-documented and accessible to relevant stakeholders.

CUSTOMER SUPPORT EXECUTIVE PPC/CSE/1312209 Coordination Coimbatore Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 3 - 5 years ShareApply Basic Section No. Of Openings 1 Designation Grade Senior Executive -M24 Freshers/Experience Experience Employee Bonus FTA Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Logistics Private Limited Department Coordination Country India State Tamil Nadu Region Coimbatore Branch Coimbatore Skills Skill Customer Support CRM Tele calling Minimum Qualification Any Degree CERTIFICATION No data available Working Language Tamil English About The Role 1. Handling PAID/TOPAY BOOKINGS & DELIVERIES 2. Daily MIS UPDATE to customers 3. Prepare Reports and identify bottlenecks in the flow 4. Address customer queries and resolve in a TAT Time

CUSTOMER SUPPORT EXECUTIVE PPC/CSE/1329975 Coordination Salem Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 2 - 5 years ShareApply Basic Section No. Of Openings 1 Designation Grade Senior Executive -M24 Freshers/Experience Experience Employee Bonus FTA Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Logistics Private Limited Department Coordination Country India State Tamil Nadu Region Salem Branch Salem Skills Skill Customer Support Tele calling Excel Tele communication Minimum Qualification Degree CERTIFICATION No data available Working Language English Tamil About The Role function as dedicated SPOC for assigned customers and regional agents. Work periodically with Assigned Customers and send MIS Reports to customer on daily basis Role of SPOC (Single point of contact) for assigned customers is to be honored in terms of queries addressing, MIS Reports and other communication. Queries to be responded and resolved within TAT. internal reports to be maintained on calls and queries addressed.

Ensuring annual budget plan adherence of all administrative related services to the entire factory Ensuring availability of infrastructure related services like workstation, computer/ laptop, intercom, mobile connection, etc to all employees Ensuring adherence to norms and policies in terms of new joining facilities like payment for shifting, allotment of car with respect to companys car policies, etc Ensuring smooth joining process of new employee by providing him/her all the services entitled to him according to his grade and the policy Ensuring proper management of travel related services to all employees in terms of local taxi, flight, bus, train, hotel, guest house bookings, etc Ensuring proper colony management, housekeeping, horticulture, and maintenance of other facilities like wash rooms, cabins, halls, discussion rooms, etc Adherence to and Implementation of OHSAS , Sustainability, ESOPS and EMS Guidelines and Principles and Preparation and Maintenance of all necessary documents Critical Skills Sets : Application Knowledge of Sales, Service and Marketing processes Quality Core Tools - SPC, FMEA, MSA, APQP, PPAP and Process Validation etc Application knowledge of QC Tools and Basic Statistics as we'll as advanced statistical tools and techniques Standardization (DWM, System Development and Policy Management) Business Lean Auditing and Assessment Skills (Preferably an IMS Auditor) Data Analytics and Business Tools Learning Enabler (Training Management, Influencing and Facilitation Skills) Good Communication and Presentation Skills and ability to work across hierarchies Qualifications Graduation

1 Supervise & Monitor manufacturing and packaging activity. 2 To guide, supervise, co-ordinate, manage and lead a team of production officer and production operators in execution of manufacturing operation to achieve the stated goals. 3 Preparation, review and implementation of SOPs and Formats pertaining to manufacturing Department. 4 Preparation and review of URS for manufacturing department. 5 Imparting training of manufacturing SOPs and GDP to Production Operators and Production Officers. 6 Preparation and review of Performance Qualification batch record and protocol. 7 Executing and reviewing of manufacturing equipment qualification activity. 8 Execution and supervision of the Process Validation/Stability batches/Commercial batches. 9 Preparation and Review of Master Batch Manufacturing Records and Master Batch Packaging Record for Process Validation / Stability Batches / Commercial Batches and other relevant documents. 10 Review, execution and implementation of Batch Manufacturing Records, Process Study Protocols and Process Study Reports. 11 Management of day to day product related activities for timely execution of the assigned products through internal communications with internal departments like Purchase, Store, QA,QC,HR & Admin, Engineering, Maintenance team etc. and external communications with Tooling vendors and Equipment manufacturers. 12 Maintaining the department in accordance with the CGMP norms. 13 Responsible for initiation, assessment and closing of any deviation and change control regarding to manufacturing activity. 14 Work distribution to production officer and production operator. 15 Any work assigned by the Dept. head after proper training. 16 To raise the indent and capex as per requirement. 17 Activities other than defined in the Job Description are to be done, as per the requirement of HOD, by following HOD s instructions and guidance. 18 Coordination and management of training activity of Manufacturing department.

Review and monitoring of equipment s and system qualification/validation. Preparation and review of Validation Master Plan Knowledge of HVAC, waters system, utility qualification Knowledge of process validation To perform failure investigation To initiate and review of change control, deviation, CAPA Auditing skill Knowledge of current regulatory requirement

1 Supervise & Monitor manufacturing and packaging activity. 2 To guide, supervise, co-ordinate, manage and lead a team of production officer and production operators in execution of manufacturing operation to achieve the stated goals. 3 Preparation, review and implementation of SOPs and Formats pertaining to manufacturing Department. 4 Preparation and review of URS for manufacturing department. 5 Imparting training of manufacturing SOPs and GDP to Production Operators and Production Officers. 6 Preparation and review of Performance Qualification batch record and protocol. 7 Executing and reviewing of manufacturing equipment qualification activity. 8 Execution and supervision of the Process Validation/Stability batches/Commercial batches. 9 Preparation and Review of Master Batch Manufacturing Records and Master Batch Packaging Record for Process Validation / Stability Batches / Commercial Batches and other relevant documents. 10 Review, execution and implementation of Batch Manufacturing Records, Process Study Protocols and Process Study Reports. 11 Management of day to day product related activities for timely execution of the assigned products through internal communications with internal departments like Purchase, Store, QA,QC,HR & Admin, Engineering, Maintenance team etc. and external communications with Tooling vendors and Equipment manufacturers. 12 Maintaining the department in accordance with the CGMP norms. 13 Responsible for initiation, assessment and closing of any deviation and change control regarding to manufacturing activity. 14 Work distribution to production officer and production operator. 15 Any work assigned by the Dept. head after proper training. 16 To raise the indent and capex as per requirement. 17 Activities other than defined in the Job Description are to be done, as per the requirement of HOD, by following HOD s instructions and guidance. 18 Coordination and management of training activity of Manufacturing department.

MISSION To lead the industrialization of the new P1 To improve the production efficiency (machine & Direct Labor) in its perimeter Capitalize and share the know-how of industrial processes in his domain To participate on the design of new equipment and new lines To lead Lean design workshop Industrialization To manage production equipment introduction using IPROM To follow equipment or assembly lines development with the supplier To design small tool and validate the supplier proposal To define the acceptance criteria for new equipment or line To perform pre acceptance and acceptance of the equipment To perform trials on the lines and deliver reports To built action plans and follow up to be ready for FDPR To perform and/or collect, capabilities of equipments and process To set up equipment and propose PROCESS VALIDATION PLAN To participate on PFMEA and CONTROL PLAN Mass production To monitor QCDM and propose improvement To survey the performance of equipments , and always in mind, optimization To work on Cycle time reduction to optimize investments, material & labor costs To update routing on Information system with SPV validation To support production technician ( training, analysis, problem solving) To be in contact with the suppliers ( improvement, support) To participate to SPV workshop To participle to APU QRQC Standardization Validate PG RAISE and CdC standards which are created by Standard Owners Validate any change of standard proposed by sites To know, apply and promote the standards ( PG, sites or corporate) in his domain To apply the SPV rules Environment Ensure the respect of Safety and Environment procedures of Valeo Group Maintain the 5S and report issues Alert for safety rules infringement

Deveop thorough test pans and document the resuts and progress Deveop in-depth functionaity and stabiity automatic tests that wi map customer use cases Research the right set of workoads and benchmarks Deveop automated test scenarios and environments for End2End automatic evauation Coect test evidence measurements to ensure system functionaity, stabiity and scaabiity Estabish automatic measures to assess the accuracy Anayze resuts to find ways to improve functionaity coverage Anayze root causes and identify areas for improvement Coaborate with deveopment teams to drive resoution for issues and improvement Generate test automation summary reports for stakehoders review Required education Bacheor's Degree Preferred education Master's Degree Required technica and professiona expertise 8-12 years of test automation deveopment experience 6-10 years of experience in software testing in the workpace 4-6 years experience in Python/Go/Java programming Good Engish communication skis (written and ora) and be abe to work independenty and as part of a team. Knowedge of REST technoogies is an important advantage. Preferred technica and professiona experience Coud network concepts incuding software defined networking, virtua private coud (VPC), network services such as oad baancer, firewa, gateway as it fits in coud network infrastructure Working knowedge of coud network infrastructure technoogies Linux network internas Linux Virtuaization technoogies reating to network virtuaization Kubernetes, Docker Knowedge of bash, go ang, php, awk Working knowedge of Network toos is an important advantage. Knowedge of Windows and Linux operating systems Knowedge of Github and Jira is an advantage. Fast earner and a team payer

The SIEM Administrator wi be responsibe for administering the depoyed SIEM service. The candidate is aso expected to have hands on experience of depoying a SIEM soution from scratch, where the candidate shoud have the skis and knowedge to gather a the required information to buid the SIEM soution. In-depth knowedge of technica approaches in security anaytics, monitoring and aerting. Maintains technica knowedge within areas of expertise. This roe is aso responsibe for identifying, anayzing, deveoping new or tuning & Refinement of the content or use cases. Strong probem soving and troubeshooting skis incuding the abiity to perform root cause anaysis for preventative investigation Required education Bacheor's Degree Preferred education Master's Degree Required technica and professiona expertise Shoud have experience in any of the query anguage i.e AQL ,KQL, SPL, LEQL etc for writing the compex queries & saved search creation. Shoud have strong knowedge of different cybersecurity frameworks i.e.MITRE, NIST and Cyber ki chain mode. Shoud have understanding of reguar expression writing and custom parsing Preferred technica and professiona experience Coaborate with key stakehoders within technoogy, appication and cyber security to deveop use cases to address specific business needs. Create technica documentation around the content depoyed to the SIEM. Creates and deveops correation and detection rues with SIEM soution, reports & dashboards to detect emerging threats

We are looking for a meticulous and experienced Technology Transfer Manager to spearhead the efficient transfer of technology for solid dosage forms at Evertogen Life Sciences . This pivotal role involves overseeing the seamless transition of OSD products from R&D or third-party development to our manufacturing plant, ensuring successful scale-up, unwavering regulatory compliance, and adherence to the highest quality standards. The ideal candidate will champion the preparation and review of critical technical documents, including technology transfer protocols, BMR/BPR, and process validation reports, while actively coordinating with cross-functional teams such as QA, QC, RA, and Production. This role demands a proactive individual adept at troubleshooting technical challenges, participating in scale-up batches, and driving continuous improvement initiatives. If you are passionate about optimizing pharmaceutical manufacturing processes, possess a strong understanding of QbD principles, and thrive in a collaborative environment, we encourage you to bring your expertise to Evertogen and contribute to our mission of delivering high-quality, affordable medications to the global market. Your contributions will directly impact our ability to meet client needs and maintain a diverse product portfolio. Job Details: Industry : OSD Formulation (Pharmaceuticals) Department : Technical Transfer Role : Assistant Manager Tech Transfer Location : Jadcherla Compensation : Up to 15 LPA Experience : 8+ years Employment Type : Full-time Qualification : M.Pharm / B.Pharm / M.Sc. in Pharma or related field Responsibilities: Technology Transfer Execution & Documentation: Lead technology transfer projects for solid dosage forms, ensuring adherence to timelines and quality standards. Develop technology transfer protocols covering critical process parameters and quality attributes. Oversee preparation and review of essential documentation (Technology Transfer Plans, Gap Analysis Reports, Process Flow Diagrams, BMR, BPR, Process Validation Reports). Coordinate cross-functional activities (R&D, Manufacturing, QA, RA) for seamless transfer and scale-up. Monitor process performance, addressing deviations or challenges. Maintain detailed records of technology transfer activities, ensuring compliance and data integrity. Ensure documentation adheres to cGMP, regulatory requirements (US FDA, EU EMA), and internal standards. Manage document archival and retrieval. Process Validation & Scale-Up: Participate in process validation activities for robust manufacturing processes of OSD Formulations. Analyze process data to identify CPPs and CQAs for process control strategies. Troubleshoot technical issues during scale-up and validation, implementing corrective actions. Evaluate the impact of process changes on product quality. Collaborate with engineering and production to optimize manufacturing processes. Ensure compliance with validation lifecycle management. Quality & Regulatory Compliance: Ensure compliance with cGMP, regulatory requirements (US FDA, EU EMA), and internal standards. Conduct risk assessments and implement mitigation strategies. Participate in audits, addressing findings and implementing corrective actions. Maintain understanding of regulatory requirements and best practices in OSD Formulation. Oversee CAPA implementation. Promote a culture of quality and compliance. Technical Troubleshooting & Continuous Improvement: Lead troubleshooting during initial commercial batches, identifying root causes and solutions. Apply problem-solving methodologies to address technical challenges in OSD Formulation. Identify process improvement opportunities. Utilize SPC tools to monitor process performance. Implement Lean Six Sigma principles. Champion continuous improvement. Cross-Functional Collaboration & Stakeholder Management: Coordinate with QA, QC, RA, and Production teams. Facilitate communication and collaboration among teams. Manage stakeholder expectations. Build relationships with internal and external partners. Generate progress reports, highlighting milestones, challenges, and risks. Present technical data to teams and management. Lead meetings to discuss project status and make decisions. Act as a liaison between R&D, Manufacturing, and stakeholders. General Expectations and Past Experiences: Possess 8+ years of hands-on experience in technology transfer within OSD manufacturing, demonstrating a strong understanding of the entire process lifecycle. Demonstrate proficiency in preparing and reviewing critical technical documents such as technology transfer protocols, BMR/BPR, and process validation reports. Exhibit a thorough understanding of Quality by Design (QbD) principles and their application in pharmaceutical manufacturing. Showcase strong technical troubleshooting skills with the ability to identify and resolve issues during scale-up and commercial manufacturing. Proven ability to coordinate and collaborate effectively with cross-functional teams, including QA, QC, RA, and Production. Demonstrate a solid understanding of regulatory guidelines (US FDA, EU EMA) and CGMP compliance requirements for pharmaceutical manufacturing. Experience risk assessment methodologies and CAPA management systems in a pharmaceutical setting.

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Assistant Manager QA Job Requisitions No : 13774 Job Description Purpose of Job Responsible for overall Monitoring and Compliance of documentation and IPQA activities of DS Manufacturing related to Manufacturing facility Responsible for APQR preparation related to CI & DS, Skill Required Good Review skills with exposure of Biopharma QA Roles and Responsibilites Review of new & revised documents i-e SOP, BPCR, MPCR, PTD, TTD, Validation Protocol, Report and QRM related to BBM facility, Review and to ensure timely completion of BPCR of products (CI and DS) manufacturing in BBM for release Authorized for batch release of Critical Intermediates, Drug substance and associated in-house media, buffer and column BPCRs, Review, monitoring and follow up for timely completion of CAPA, Deviations, Change Controls, OOT, OOS, IQA/external audit observations/, etc Handling and Assessment of Breakdowns, Alarms, SAP Incidents, ERN related to BBM facility Review of electronic data/audit trail data related to BBM facility, Monitoring and participation in process validation activities of BBM Review/Approval and compilation of Process validation documentation, Monitoring and participation in cleaning validation activities of BBM Review/Approval and compilation of cleaning validation documentation, Issuance of Working Cell Bank & Master Cell Bank, EPCBs and related documentation Ensuring physical reconciliation of cell banks, Qualification Required Sc Relevant Skills / Industry Experience Good Review skills QA Biopharma experience of more than 7-8 years, Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Biotech, Ahmedabad, GJ, IN, 382213 Travel: 0% 25% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

Job Description Educational Qualification B Pharm / M Pharm Experience 03 06 years experience of external preparations, Ointment and OSD IPQA activities Job Location Nashik Job Responsibilities - Totrack batches for process validation, packing validation and hold time study, Certificationof Appropriate and timely Line-Clearance for Manufacturing, Packing, Dispensing&coding, Tocarry out the online in process checks& to take on line SAP entries, ToWithdraw & Submit the Samples (Analysis SFG and FG & Control samples,Validation, Regulatory, R&D, Hold time study & Micro samples) toConcern Dept as & when required, Toensure the cGMP on the shop floor and to highlightthe on line Problems / Non Conformances with the respect to Procedures,Specifications, SOPs, cGMP etc on day to day basis Numbers ofcritical/major nonconformance noticed, OnlineBPR, Logbooks completion & Review of documents like Preventive maintenance,calibrationrecords, daily/weekly cleaning, quarantineregister etc in the Concerned dept, Issuanceof Batch Manufacturing Records and Batch Packing Records to productiondepartment, Reviewof Executed Batch Manufacturing Records and Batch Packing Records Toverify online finished goods before transfer to BSR,

Excellent opening for Process Validation role in Quality Assurance in Unison Pharmaceuticals, Moraiya Company: Unison Pharmaceuticals Website: www.unisonpharmaceuticals.com Department: Quality Assurance Location: Unit III, Moraiya, Ahmedabad Designation : Process Validation: Executive/Sr. Executive Experience: 3-9 Years (In PV) Qualification: B.Pharm/M.Sc Job Description : Prepare process validation protocol and send for review, approval and authorization to concern team members Facilitate process validation training to production, QC and IPQA Collect samples from Granulation, Compression / Capsule filling and Coating stages and send to QC for analysis Perform required documentation activities like; utilization log and test request slip Compile data for each batch performed under validation stage Prepare process validation report post completion of the 3 validation batches and send the report for review and approval Please submit your resume to career@unisonpharmaceuticals.com to be considered for this role. Join our team at Unison Pharmaceuticals and take the first step towards a rewarding career.

Job Description 1. Preparation of SOPs of QA, review of other departments' SOPs, 2. To perform batch release of API material and review of related documents. 3. To prepare and review Quality Risk Assessment, Site Master File, Hold Time Study Protocol/Reports, and other study protocols/reports, Specifications, Stability Protocol, and Stability Report Data. 4. Review of Validation Master Plan. 5. To review the analytical method transfer protocol/report and method validation documents of the API. 6. To ensure and handle the investigation of out-of-specification Results, OOT, Deviations, Product failures, and Market Complaints. 7. To review Quality system documents such as Deviation, Change control, CAPA, OOS, OOT, re-processing, Re-work, market complaints, and market returns. 8. To review Qualification Protocols/Reports of product, equipment, and facility. 9. To Review of the Annual Product Quality Review. 10. To review of Master Document, such as BPR, Test and Calibration Data Sheet, Test Procedures, and Microbiological Test Procedures. 11. To collect, review, and submit documents to the RA Department for dossier preparation /Regulatory Submission. Work Experience 5 to 8 Years Education Post Graduation in Chemistry Competencies