449 Process Validation Jobs - Page 4

As a qualified candidate with a Master's degree in Chemistry and 3 to 8 years of relevant experience, you will be responsible for various key activities in the near Vadodara location. Your primary tasks will include managing deviations, implementing quality systems, ensuring regulatory compliance, conducting process validation, and handling documentations and audits effectively. This full-time, permanent position offers benefits such as Provident Fund along with a day shift schedule. The work location is on-site, requiring your presence for the successful execution of the mentioned responsibilities.,

The Technology Transfer Associate is responsible for coordinating and executing the seamless transfer of pharmaceutical products to Ritsa manufacturing Facility from client /R&D or result in any merger or acquisition. This role will oversee the planning, execution, and completion of projects with end-to-end accountability for deliver in time This role ensures that all processes (analytical and manufacturing) are effectively transferred while maintaining compliance with regulatory requirements, quality standards, and operational efficiency. Key Responsibilities: Project Planning and Execution Define project scope, objectives, deliverables, and timelines. Develop detailed project plans, alloca...

Position Title: Manager Formulation & Development – Tech Transfer Department: Formulation & Development Location: Vadodara Reports To: Job Overview: The Manager – Formulation & Development will oversee the successful transition of products from development (R&D or other manufacturing sites) to commercial manufacturing. This role requires in-depth expertise in technology transfer, quality control, scale-up processes, and regulatory compliance, ensuring seamless manufacturing operations and product quality. Key Responsibilities: Review of Technology Transfer Dossier (TTD): Conduct detailed reviews of TTDs to ensure accuracy, completeness, and alignment with manufacturing capabilities. Assess p...

Role & responsibilities Complete knowledge of Validation ( AHU / Autoclave / Dry Heat Sterilizer etc ) and Calibration -Capable of Compiling the Validation and calibration Activities -Good Computer Skill Preferred candidate profile CLEAN SHAVEN MALE CANDIDATE WITH MINIMUM 2-3 YEARS EXPERIENCE IN STERILE INJECTION SECTION

The role involves handling document issuance, distribution, and retrieval, including verification of various documents such as Batch Manufacturing records, Protocols, layouts, specifications, etc. Issuing approved Standard Formats and Logbooks to User Departments, as well as managing line-clearance checklists, interventions checklist, and BMR/BPR pages. Additionally, handling proposed changes per the change control procedure, assessing associated risks/impacts, and ensuring the implementation of action plans. Conducting investigations using root cause analysis tools, performing additional studies, and deriving appropriate CAPA. Managing recommended CAPA and evaluating the implementation of r...

As a Quality Assurance Specialist, your responsibilities will include reviewing all Master Production and Control Record (MPCR) and Batch Packing Records (BPR), as well as Standard Operating Procedures (SOPs). You will need to meticulously review specifications and testing procedures for starting materials, packaging materials, in-process products, finished products, working standards, and stability (Shelf life). Additionally, you will be tasked with reviewing Out-of-Specification (OOS) investigation reports and participating in investigations related to complaints, vendor audits, external testing laboratories audits, and the subsequent Corrective and Preventive Actions (CAPA). You will also...

The Lead will be responsible for ensuring the timely completion of activities related to the process validation of orders and all statutory requirements, as well as budgetary control MIS and other system-related issues. They will provide commercial support to ensure seamless functioning through inputs on direct tax, indirect tax, finance, legal matters, and tax optimization. Key Responsibilities: - Review and validate purchase orders and contracts from a commercial and finance perspective. - Ensure the optimization of taxes and duties through knowledge of both direct and indirect taxation. - Implement tax optimization strategies for package items, construction contracts, and work contracts. ...

1. API synthetic process tech transfer to plant and scale-up at plant. 2. BMR and scale-up documents preparation. 3. Process Validation 4. Plant batch trouble shooting 5. Production of API at plant. Required Candidate profile 1. Knowledge of process development and tech transfer 2. API plant working experience 3. Working experience in pharma company with good production knowledge. 4. Knowledge of GMP

Skill Required Roles and Responsibilites 1. Media fill and qualification summary preparation knowledge. 2. To maintain track of qualification and validation activities. 3. To prepare and review the protocols and reports. Execution of various qualification / validation activities. 4. To review correctness of the technical documents received from the supplier (DQ/OQ/IQ/PQ,FAT). 5. Co-ordinate with production and other user department for qualification/validation activities 6. Timely compile and review of qualification validation reports. 7. To review the equipment documents like calibration reports and ensure correctness of documents. 8. To perform FAT. 9. To co-ordinate with outside agencies ...

Purpose of Job 1. Preparation and Review of PQR. 2. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. Skill Required 1. Having basic knowledge on Microsoft Word and Microsoft Excell 2. Have knowledge of Minitab software for statstical evaluation of data. Roles and Responsibilites 1. Preparation and review of PQR schedule. 2. Planining of PQR compilation as per PQR schedule. 3. Collection of data from all the CFT teams for compilation of PQR. 4. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. 5. Based of the PQR data recommendation to be recommended to concern depa...

Purpose of Job 1. Preparation of PQR. 2. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. Skill Required 1. Utilization of Microsoft Word and Microsoft Excell 2. Using of Minitab software for statstical evaluation. Roles and Responsibilites 1. Preparation of PQR schedule. 2. Planining of PQR compilation as per PQR schedule. 3. Collection of data from all the CFT teams for compilation of PQR. 4. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. 5. Based of the PQR data recommendation to be recommended to concern department and ensure implemenation of the same. Quali...

Skill Required 3 to 4 year Pharma background experience for FP , In process and PV samples. Roles and Responsibilites To analyze the samples of in process/FP/Process validation as per work allotted by section in charge/Designee. Preparation of report and submission of reports along with raw data to section in charge/Designee within time. Immediate reporting of any odd observation, incident, OOT and OOS result during analysis to section in charge/Designee. Qualification Required M.sc/B.pharm Relevant skills / Industry experience Should have 2 to 4 year experience. Relevant professional / Educational background M.sc/B.pharm

Roles and Responsibilites 1.In process Quality Assurance activity in Production and warehouse area 2.Provide line clearance as per SOP 3.Monitoring and QA rounds in production and Warehouse 4.Sample verification against TRF / BPCR 5.Carry out Semi-finished / finished product sampling for release, stability study and control samples 6.To send samples along with TRF to Quality control laboratory 7.Participate in media fill, process validation, cleaning validation activities as per requirement 8.Timely communication and co-ordination with all the stake holders 9.Participation in Change control, Deviation & Investigations as per requirement 10.Preparation / review of documents like; SOPs, risk a...

Job Title: Machine Learning Engineer Job Type: Full-time About Us: Our mission at micro1 is to match the most talented people in the world with their dream jobs If you are looking to be at the forefront of AI innovation and work with some of the fastest-growing companies in Silicon Valley, we invite you to apply for a role By joining the micro1 community, your resume will become visible to top industry leaders, unlocking access to the best career opportunities on the market, Job Summary Join our customer's team as a hands-on Machine Learning Engineer, where you'll play a pivotal role in shaping, deploying, and automating end-to-end machine learning pipelines Leveraging your expertise in AWS ...

Design & develop API/intermediates processes, optimize & validate methods, analyze data (HPLC, GC, NMR, IR, MS), handle impurity profiling, maintain documentation & lab records, and ensure equipment upkeep. Required Candidate profile 6-8 Years of experience BSc./ MSc. in Chemistry

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our flexible, innovative, and customer-oriented quality culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work. What You Will Achieve I...

Intermediate batches release in SAP. All SAP related changes are tested on development server, quality server and then implmeneted on Production server e.g. MQC testing and implementation, preparation of test scripts for all SAP changes, updation of master documents numnbers in SAP, updation of overages symbols in SAP, MSCN2 changes in SAP. Food control sample review. Issuance of packing material COfA for all interlocations transfers. For Raw materials also this activity will start now. Checking of goods during dispatch of product at BSR level after repeated complaints from Vietnam of theft. Shipper weight checking before transfer to FG BSR. Measuring cylinder calibration. 8. Micro sample fo...

Seeking a IPQA Executive to ensure skincare products meet regulatory, safety & quality standards. Work closely with manufacturing, R&D, and QC teams. Requirement: 2+ years of QA experience, preferably in cosmetics or pharma manufacturing. Required Candidate profile Skincare manufacturing & QC expertise Knowledge of FDA, GMP, ISO regulations Attention to detail & procedural compliance Strong analytical, problem-solving & com skills Ability to work with GMP proces

As an Officer - Production at Dishman Carbogen Amcis Limited in Bavla, Gujarat, IN, your primary responsibility will be to carry out the production process in accordance with production Batch Manufacturing Records (BMR). This includes online documentation of BMRs, Engineering Change Requests (ECRs), Batch Production Records (BPRs), logbooks, and daily record filling. You will be accountable for verifying the raw materials, packing materials, and cleaning materials issued by the warehouse, ensuring proper segregation, labeling, identification, and area cleaning. Your role will involve the manufacturing of Key Starting Materials (KSM), Intermediates, and Active Pharmaceutical Ingredients (API)...

Ensures Products meet established standards by developing and implementing quality control procedures, conducting audits, monitoring performance metrics, and resolving quality issues. Maintain documentation, Ensure compliance with Pharma regulations Required Candidate profile M.Sc - B. Pharma - M. Pharma - BE - Chemical Good knowledge Of Quality Assurance Good Command over English And Computer Must be ready to face customers Inquiries And Local And US FDA Authority

Works closely with the Lead Scientist to develop and refine pouch formulations, Focuses on ingredient optimization, flavor blending, and pilot-scale testing Supports transition from lab to production. Required Candidate profile M. Pharma with 8+ years of experience in oral formulations and operations in pharmaceuticals.

Oversee all R&D initiatives for nicotine pouches and related oral dosage innovations Leads formulation strategy, raw material research, stability studies, and new product concepts acts as the technical head for regulatory submissions and IP. Required Candidate profile Experience in pharma and oral drug delivery products.

Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what s possible and making headway to help improve outcomes. Project Management Scope: Review all tasks already completed and develop a clear overview of the current project status Manage and track all deliverables and resulting actions Plan the project to completion, including milestones and due dates Lead the validation process, considering that some team members have limited experience in validation Use Integra s Validation SO...

Job Description: As a Quality Compliance Associate in a manufacturing environment, you will be responsible for ensuring quality compliance, documentation, and adherence to industry standards. Your key responsibilities will include conducting quality checks and inspections of raw materials and finished products, ensuring compliance with GMP, ISO, and regulatory standards, maintaining quality documentation, and assisting in audits. You will also be involved in supporting process validation and implementing quality control measures while collaborating with production and R&D teams for quality improvements. To excel in this role, you should possess a B.Sc/M.Sc in Chemistry, and freshers are enco...

You will be responsible for conducting line clearance activities before starting various operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing. Additionally, you will perform environment monitoring activities and ensure compliance with cGMP at the shop floor. Your role will involve process validation, cleaning validation/verification, hold time study, media fill, routine batch sampling, and in-process testing at different stages according to batch documents and SOPs. You will review executed BMRs, BPRs, environment monitoring data, water trends, printouts (CIP, SIP, autoclave, filter integrity), and different types of planner and calibration certif...