449 Process Validation Jobs - Page 7

Job Description To review/approval/closure, rejection/drop (if required) of Quality system documents such as Deviation, change control, CAPA, OOS, OOT, Re-process & Re-work, market complaint, market returns & LIR. To ensure & handle the investigation for Out of Specification Results, OOT, Deviations, Product failures and Market Complaints are adequately performed and documented with appropriate Quality Risk Assessment activity, Corrective and Preventive Actions based on the results of the investigations are identified and implemented. To preparation review & Approval of Quality system trend. To verify In-process Quality Assurance during production activity and sampling at different stages of...

Experienced in preparation,execution&review of process/cleaning validation,equipment qualification,calibration, preventive maintenance, and validation schedules. Ensures effective implementation validation master file. resume to hrd@stedmanpharma.com

Job Title : Assistant Manager Or Deputy Manager Job Location : Hyderabad Department : QA Reports to : HOD Job Objective : To perform the QA activities in view of system upgradation and improvement in the existing procedures. Job Role: 1. Execution & co-ordination for investigations, Identification of root cause along with assignment of adequate CAPAs for Returned material, Incidents, Deviation, OOS, OOT, complaints & other quality events. 2. Logging, Review & Closing of the change controls and CAPAs along with implementation of CAPA and its effectiveness verification as applicable. 3. Responsible as site representative during Regulatory Audits and customer inspections to co-ordinate with the...

As a Sr. Executive / Assistant Manager Quality Assurance (QA) at SAVA Healthcare Limited, Surendranagar Plant, your primary responsibility is to ensure the implementation and maintenance of cGMP practices, quality systems, and compliance with regulatory requirements. You will oversee QA activities including documentation, validations, audits, and shop floor compliance to uphold product quality and regulatory adherence. Your key responsibilities will include ensuring compliance with cGMP, SOPs, and regulatory requirements on the manufacturing floor, reviewing and approving batch manufacturing records (BMRs) and batch packing records (BPRs), handling deviations, change controls, CAPA, and qual...

Responsible for leading production operations, coordinating production staff and equipment, ensuring product quality and profitability, and overseeing and managing the production operations involved in injectable products.

You will be responsible for conducting literature searches, gaining a thorough understanding of the product, and interpreting data for product development purposes. Additionally, you will design primary product strategies and prepare product strategies for discussion with group leaders or team leaders. Your role will involve planning and executing product development work to achieve the desired product profile, as well as compiling data. You will be required to schedule work plans in consultation with group leaders or reporting authorities to ensure timely project completion based on assigned priorities. Furthermore, you will carry out the execution and evaluation of various formulation opti...

Cyano Pharma Pvt Ltd is a leading pharmaceutical organization in INDORE (MP) focused on quality, compliance, and innovation. We are looking for a highly skilled professional with strong expertise in Quality Management Systems (QMS) and Validation & Qualifications to ensure compliance with international regulatory standards (WHO, USFDA, EMA, MHRA). Key Responsibilities: Quality Management System (QMS): - Implement, maintain, and continuously improve the site Quality Management System in line with global regulatory guidelines (WHO, USFDA, EMA, MHRA). - Prepare, review, and update SOPs, quality manuals, and quality policies. - Manage change control, deviation, incident reporting, and risk manag...

As an Executive in MSTG at Sun Pharmaceutical Industries Ltd, your primary responsibility involves executing technology transfers to Sun/CMO sites, overseeing scale-up processes, exhibit batches planning, and process validation. This requires effective planning and efficient utilization of resources such as manpower, materials, and machinery. You will be responsible for various documentation tasks including the preparation of new production introduction forms, scale-up reports, reviewing Sun/CMO Batch Manufacturing Records (BMR), developing sampling plans, process validation (PV) protocols, User Requirement Specification (URS) preparation, and Dashboard preparation. It is essential to ensure...

Literature search, product understanding, data interpretation for product to be undertaken for development. Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader. Planning and execution of product development work to achieve desired product profile and data compilation Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation Laboratory notebook writing and assistance in documentation of controlled documents and compilation the development data Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufactur...

Literature search, product understanding, data interpretation for product to be undertaken for development. Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader. Planning and execution of product development work to achieve desired product profile and data compilation Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation Laboratory notebook writing and assistance in documentation of controlled documents and compilation the development data Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufactur...

As a Validation Specialist at Piramal Pharma Solutions, your primary responsibility will involve preparing and updating various validation documents to ensure compliance with regulatory requirements. This includes developing Validation Master Plans (VMP), Process Validation protocols, Computer System Validation protocols, and reports. You will also be responsible for creating product matrices, Cleaning Validation/Verification protocols, qualification/requalification protocols for equipment/instruments, utilities, and facilities, as well as area validation protocols and reports. In addition to validation activities, you will be involved in quality risk assessments, review of calibration certi...

As Manager 2 in the Corporate Quality department at SUN Pharma, you will be responsible for overseeing the quality aspects of contract manufacturing organizations (CMOs) involved in manufacturing site transfer products for the US market. Your primary focus will be to ensure compliance with SUN Pharma Quality and Compliance Standards as well as global regulatory requirements. Your essential job functions will include monitoring and overseeing activities at CMO sites to ensure adherence to SUN Pharma standards and regulatory guidance. You will conduct regular oversight visits, prepare visit reports, and serve as the main point of contact for coordination between SUN site, commercial team, corp...

As an NPD Manager, you will be responsible for leading the end-to-end new product development process, ensuring compliance with industry standards, and driving innovation by identifying new technologies and materials. You will develop and manage project timelines, budgets, and resource planning for NPD initiatives, while coordinating with cross-functional teams to monitor project progress and address risks for timely product launch. Your role will involve working closely with customers and suppliers to understand requirements, conducting market research to identify industry trends, and providing technical support during customer discussions and presentations. You will implement best practice...

Should have the experience in activities like QMS Activity, BMR Review, Change Control, Document Issuance, Vendor Qualification, Process Validation etc. Process validation / equipment Qualification protocol preparation and review Required Candidate profile Vendor qualification and validation

Roles and Responsibilities Responsible to design validation/ qualification strategies. Responsible for validation /qualification of processing equipment's, cleaning equipment's and testing equipment's on time. Responsible to review & approve of validation /qualification protocols and reports. Responsible for day to day validation planning and execution activity. Planning, Execution & Participation of aseptic process simulation activity. Responsible for process validations, hold time studies, thermal studies, transport validation, filter validation etc but not limited. Responsible to design, review, approve and implementation of departmental standard operating procedures. Responsible to revie...

Literature search, product understanding, data interpretation for product to be undertaken for development. Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader. Planning and execution of product development work to achieve desired product profile and data compilation Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation Laboratory notebook writing and assistance in documentation of controlled documents and compilation the development data Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufactur...

Literature search, product understanding, data interpretation for product to be undertaken for development. Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader. Planning and execution of product development work to achieve desired product profile and data compilation Scheduling the work plan in consultation with group leader/ reporting authority for timely completion of the projects based on priority assigned. Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation Laboratory notebook writing and assistance in documentation of controlled documents and compilation of t...

Issuance & retrieval of BPCRs/ ECRs/ formats/ log books etc. Preparation of QA SOPs and list of SOPs. Follow-up cross functional team for periodic review and review of other departmental SOPs as and when required. Distribution of controlled documents e.g. SOPs, specification etc. QC Analytical Raw data and sampling and review checklist Issued. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline

Amgen harnesses the best of biology and technology to fight the world s toughest diseases, and make people s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what s known today. In this role you will be serving patients through internal collaboration with Amgen s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen s missions of serving ...

Preferred Education/ Qualification B. Pharm/M. Pharm/M.Sc. Experience: 4 6 years of experience in Quality Assurance / MQA of sterile dosage manufacturing facility. Core Competencies : Technology Transfer Change Management process Risk assessments principles and tools Validation of manufacturing equipment s Drug Product Process validations Regulatory requirements Compendial Changes Technical Skills Fundamental knowledge on manufacturing and Quality control activities, such as Solution preparation, filling, terminal sterilization, visual inspection, packing, in process sampling and analysis. Technical document review skills Knowledge in change control assessment Knowledge on manufacturing proc...

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary To Manage the entire qualification and validation activities in the site specifically related to equipment/utility qualification, cleaning validation, process validation, packaging val...

Role & responsibilities To execute activities related to R&D Process Development, along with a group comprising of Research Officers/ Research Assistants under guidance from the Project Leader/Group Leade Require to Plan and carry out Chemistry related experiments, recording the observation in Protocol Computer literacy etc. Job Description: Literature search with respect to assigned project and its documentation Experimentation (Process development, optimization and validation) Analysis, interpretation (HPLC, IR, NMR, Mass and CHN) and documentation of data General Laboratory Management etc. Scale-up and Technology transfer activity Project related impurities synthesis.

Role & responsibilities Process control Seamless working with shop floor team for process improvement activities Innovate and implement robust processes to minimize the deviations in components Preferred candidate profile Hands on experience in process technology and trouble shooting . Should have hands on experience in analyzing and understanding of process problems and provide the guidance for improvements. Usage of analytical tools and technique to address non-compliances in components and provide the solutions

Valeo is a tech global company, dedicated to designing innovative solutions that redefine mobility. As an automotive supplier partner to automakers and new mobility players worldwide, our primary focus is to create a greener and more secure form of mobility. Our solutions are geared towards enhancing the driving experience and reducing CO2 emissions. With a reputation as a leader in our industry, we are widely recognized as one of the largest and most innovative companies on a global scale. Your mission in this role will involve leading the industrialization of the new P1 project, enhancing production efficiency in terms of both machinery and direct labor within your designated area. Additio...

As an Assistant Manager/Manager Project, you will be required to possess a B.E/ B. Tech in Dairy Engineering. You should be proficient in English, Hindi, and Marathi languages and fall within the age bracket of 25 to 35 years. The ideal candidate should have a minimum of 6 to 12 years of experience, preferably in the Dairy Processing/Food Industry. Your key responsibilities will include having a deep understanding of various dairy products such as Liquid Milk, Butter, Ghee, Powder, Cheese, Paneer, Whey Processing production, preservation, and utilization. You must have prior experience in Green field/Brown field Project conceptualization, detail engineering, Planning, Budgeting, execution, c...