449 Process Validation Jobs - Page 12

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier...

The Senior Executive QA (Vendor Management) will be responsible for managing vendor qualification processes, preparing periodic vendor audit schedules, and ensuring vendor compliance in line with cGMP and global regulatory expectations. The role also involves reviewing and maintaining Quality Agreements, monitoring vendor performance, supporting cross-functional risk assessments, and ensuring timely closure of audit observations. The position demands strong coordination with cross-functional teams, external vendors, and regulatory bodies. Key Responsibilities: Execution and oversight of vendor qualifications Planning and coordination of vendor audits Preparation and review of Quality Agreeme...

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Data Warehouse ETL Testing Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. A typical day involves collaborating with team members to understand project needs, developing application features, and ensuring that the applications function seamlessly within the existing infrastructure. You will engage i...

Webdriver IO Appium Ensure all planning and execution of assigned QA work (Integration, System, End to End and User Acceptance, production support) in ROL and Mobile channels are addressed on time without any escalations. Participate in assigned Scrum ceremonies. Understand QA scope provide QA estimates and plan the tests. Create Test cases scripts (manual and automated) and ensure test data is in place for planned tests. Execute Tests (manual and automated) on time. Conduct ADA testing using JAWS, Voice Over, Talkback Level Access and NVDA Understand existing Automation Framework and support automation testing needs for UI and API Automation. Good communication skills and coordinate with on...

Roles and Responsibilities Conduct quality audits, BMR reviews, CAPAs, deviation investigations, change controls, equipment qualifications, process validations, and vendor qualifications. Ensure compliance with USFDA regulations through IPQA activities Engineering Documentation ,Qualifications &Validations. Warehouse Documentation ,Qualifications &Validations. Cleaning Validation Perform analytical QA tasks such as OOS management and sterility testing. Participate in MHRA / USFDA inspections by providing necessary documentation and supporting audit findings. Collaborate with cross-functional teams to resolve quality issues. Regulatory Audit Exposer LIKE FDA, MHRA, TGA Audit Reponses and Audi...

Role & responsibilities Preparation, Review and Execution of Process Validation Protocols and summary reports based on the Analytical results and Batch documents data.

Should have in depth knowledge of ISO 9001, ISO14001, & ISO 45001 standards. Certified internal auditor / Lead Auditor will be an added advantage. Proficiency in GD&T and engineering drawing standards. Knowledge about manufacturing processes / work experience in chemical etching process , electroplating , mechanical stamping, furnace operations etc. Should have detailed knowledge on process validation , feasibility study and part qualification methods. Collaborate with CFT to support new part development , process improvement, and risk management. Sound knowledge of risk assessments, PRD, CP, FMEA, and RCA (5 Why, 8D problem solving, Fishbone Diagram, and Pareto Analysis). Ability to perform...

Process Validations : You will validate manufacturing processes to ensure they meet quality and efficiency standards. Special Purpose Machines (SPM) : You will be involved in creating specifications, finalizing concepts with cross-functional teams (CFT), and overseeing the installation, commissioning, and validation of SPMs. Low-Cost Automation : You will implement low-cost automation solutions to improve efficiency. Process Layouts : You will design and optimize process layouts for new lines and existing ones. Online Troubleshooting : You will provide on-the-spot troubleshooting for tooling and process-related issues on the production line. Error Proofing : You have experience implementing ...

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 te...

Process Validations : You will be responsible for validating manufacturing processes to ensure they meet quality and efficiency standards. Special Purpose Machines (SPM) : You will be involved in creating specifications for SPMs, finalizing concepts with cross-functional teams (CFT), and overseeing their installation, commissioning, and validation. Low-Cost Automation : You will implement low-cost automation solutions to improve efficiency. Process Layouts : You will be responsible for designing and optimizing process layouts. New Lines Setup : You have hands-on experience setting up new production lines. Online Troubleshooting : You will troubleshoot tooling and process-related issues on th...

Planning & Co-ordinate Internal/ External/Customers Audits. Reviewing Customer audits and non-conformity reports and ensuring corrective actions are effectively implemented. Validation protocols and reports. Reviewing BMR, Analytical Records.

Spica Labs Pvt. Ltd. is hiring QC & QA male candidates with experience in HPLC, UV, IR, GMP, BMR review, SOPs, validation, deviations & regulatory knowledge. Send resumes to: spicalabspvtltd@gmail.com.

Nutrizo Advancis Healthcare Private Limited is looking for IPQA-Chemist to join our dynamic team and embark on a rewarding career journey Conduct in-process quality checks during manufacturing Ensure compliance with GMP and SOP standards Document results and report deviations Coordinate with QA and production teams

2 - 8 years experience into analytical compliance, cleaning sampling. RA Coordination, Process validation, QMS

Role & responsibilities: 1. Ensure the data compilation of Analytical Raw Data and its relevant log entries of In-process, Intermediates, Raw Material, Finished products, Hold time study, process validation, cleaning samples, Vendor development. 2. Planning, Monitoring of sampling, analysis and release of raw materials, packing materials and finished goods. 3. Handling of Laboratory incident and assist in the investigation of Out of Specification, Out of calibration and Out of trend results and customer complaints. 4. To coordinate with ADL/R&D for OOS investigation. 5. Responsible for all QMS activities carried out in quality control laboratory and compliance as per existing SOPs, safety an...

Involving in Validation of Batches and Qualifications of equipment's Carryout In process & review of all packing IPQA activity of Tablets, Capsules and soft gel area Calibration of Balance and all IPQC instruments. Ensuring that all Log sheets & Records are updated on-line Issuance and Review of BPR & SOPs with the operation. Line clearance related works before starting of production activity Equipment Qualification

> Role Objective: A key objective of this profile is to ensure the effective planning, execution, and documentation of validation and calibration activities, in compliance with regulatory standards and internal policies. The role focuses on maintaining high-quality standards, managing internal and external audits, and ensuring adherence to ISO 13485 and other relevant quality management standards. Additionally, the role supports continuous quality improvement initiatives and ensures that validation activities align with business needs and regulatory requirements. > Desired Candidate Profile: Bachelor's or master's degree in engineering, life sciences, or a related field. A minimum of 6 years...

Job Receiving user indents, verifying with approved budget, and floating RFQ to the vendor (minimum 2 to 3 vendors). Preparing a worksheet to validate supplier quotes based on cost, quality, OEM, and delivery lead time Knowledge of SAP for PO release. Create PSR and follow the PSR approvals stage-wise. PO release. Monitoring material delivery against committed vendor dates. Coordinating with the maintenance team for installation and commissioning. Coordinating with the logistics team. Coordinating material in warding and acceptance, and vendor payment. Asset management and handling the Audits Generating and circulating reports to management. Relevant Experience: Mechanical and Electrical, Co...

1. Utilize a broad understanding of cGMP to provide QA support, mentoring and coaching for Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and procedures, as appropriate. Required Candidate profile GMP PRO/DATA NIJNA/BMR/ANNUAL PRODUCT REVIEW/MBR/CLEANING VALIDATION

QMS Activities IPQA Activities Validation Activities Must be having experience in API Desired Profile: Designation : Officer / Executive/ Senior Executive Qualification : M.Sc. Chemistry/ B.Pharm/ M.Pharm Experience: 02 10 year

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 perf...

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, coordi...

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 - Me...