449 Process Validation Jobs - Page 15

KWALITY PHARMACEUTICALS LTD. 6TH, MILE STONE, VILL. NAG KALAN, MAJITHA ROAD, AMRITSAR- 143601.(INDIA) About Our Organisation : Kwality Pharmaceuticals Ltd. is a manufacturer of finished pharmaceutical formulations in a dosage form. The company was incorporated on May 4 1983, and is ever progressing in Domestic and International markets. Kwality Pharma was Incorporated on May 4th 1983 by Mr. Ramesh Arora ( Founder ) of the company . Our company is based on its commitment to high quality and timely supplies. Kwality Pharmaceuticals Ltd are leading manufacturer & exporters of pharmaceutical formulations in Liquid Orals, Powder for Oral Suspension, Tablets, Capsules, Sterile Powder for Injection...

To Prepare, manage and review validation master plan and cleaning validation master plan. To prepare and summarize results when writing final validation. To review and coordinate for all type of third party calibration. To prepare execute protocols and report of process validation, hold time study, HVAC, Water system and collection of samples. To initiate and evaluate of change control, risk assessment of product as well as equipment. To prepare annual product review and provide data related to validation and qualification. To follow and implement current GDP and SOP during work.

Hii, Greetings from Avaniconsulting ! We are hiring for Production associate for a leading Pharma API Manufacturing company Position- Associate Work Experience Min 3-10 yrs in API Notice Period - 1 month ( maximum) Location - Mysore ( Nanjangud) Gender - Any Qualification- B.Tech in Chemical Engineering /Msc Chemistry/Diploma Chemical/BSC Chemistry Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manu...

Role & responsibilities To establish the quality, health & safety policies, procedures, standards and specifications Maintain Certificate of Conformity for all our Products To work with the procurement team & production team to ensure quality standards To look at ways to reduce waste and increase efficiency; To set audit/ inspection procedures, protocol and checklist To conduct periodical inspections at the supplier location & also our warehouse for quality control, evaluate problems and suggest corrective action Focus on Continuous Improvement Preferred candidate profile Women candidate with Graduate in BSC Chemistry / B Pharma

Dear All, We are looking for as Junior Engineer - Tool & Process development for GTTC, NTTF & CIPET holders. Job Description. New child parts development (tool and process) to meet master schedule a. Tool spec review, Tool design review b. Inspection report review c. Tool Correction plan review d. Schedule review e. Handover tool and process f. Co-ordinate with CFT to get and share information related to NPD g. Develop facilities that is unique for the part ECI implementation and monitoring Adherence to IATF requirement Master list control QCPC,PCA,FMEA,SMH, gauges, fixtures, trim tools, dies, moulds, part weight, shot weight, RM details. Meet the IOC requirements given by PC Follow Safety r...

Vibonum Technologies, Bangalore is hring: Executive - AQA/QMS/DOC Cell Executive - IPQA/QMS Role & responsibilities Review and release the Finished products/Raw materials/ stability samples after the analysis in line with defined procedures. Review and approval of Qualification, validation documents, protocol, and reports. Initiation and / or Review and approval of QMS elements like Change controls, deviations, Out of Specifications, Out of Trends CAPA, etc. Management of Document cell (Issuance, retrieval archival and destruction of documents) to avoid any unauthorized access and usage of documents. Conduct training for newly joined Employee and existing employee and evaluate the effectiven...

ABOUT AMGEN 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. ABOUT THE ROLE Role Description We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and an...

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

Role & responsibilities Media section prepares small and bulk volume of media to produce FMD/HS antigens and related to cell and virus/ Bacterial culture sections To update the regulatory documents online Involved in microbial upstream and primary downstream processes Coordinating with internal and external departments like QC, QA, and engineering. Coordinate with cross functional department and participate in preventive and breakdown maintenance of equipment and machines Preferred candidate profile Should have experience in handling various bioreactors adherent and suspension cell cultures, cell passaging. Exposure to regulatory audits.

Work Experience (Total number of years/ experience/ background or equivalent) : Total experience (in years): 15 Experience in current role (in years): 6.5 Years Work Background: Formulation Development, Technology Transfer, Root Cause Investigations, Project Management Primary Job Function - To drive technology transfer for Third party manufacturing, Loan license projects, Abbott s own manufacturing plants. To support Abbott site MS&T team as per requirements. To support Alternate supplier qualification of raw materials & API. To comply with the regulatory, quality, statutory, EHS and Pharmacovigilance requirements. Core Job Responsibilities - To perform effective gap analysis between sender...

Role & responsibilities Validation & Qualification of Equipment Experience in Autoclave, Terminal, Sterilizer, Mixing Vessel, Tunnel Qualification, washing machine and filling machine. HVAC Qualifications Validation and qualification protocol and report. To ensure material issuance for validations activities & keep Section Manager updated. To ensure implementation of validation, qualification activities & inform to Section Manager for any deviation from written procedure. Equipment Qualification Steam Heat Sterilizer, Terminal sterilizer, Preferred candidate profile:- Result orientated Communication skills Presentation skills Analytical skills Lateral coordination * Candidate can share their...

In Process Quality Engineer ( Snr Engr/ Engr (7-8 Yrs exp) Responsibility: In process Inspection laser, TPP, Bending, Welding, Powder coating/ Passivation ) Shall have good knowledge in welding & NDT method _ preferred CSWIP / AWS certified welding inspector Experience in sheet metal Fabrication industry with knowledge on process , Validation, Qualification & Audits. Allocation of manpower – shift plan > should be capable of handling multiple process _ laser , TPP, Bending, Welding , Powder coating & Passivation. Contribute in feasibility study along with CFT Team In New product development Instrument Calibration (Verify, Issuing to line). Handling of Customers, Audits & Supporting for the s...

QA Senior Executive / Quality Assurance Manager CTC UPTO 6 LPA, Contact: 09990842892 Email: info@wellgen.in We are a 30-year-old Medicine Manufacturer Company is located in Baddi Experience : Minimum 7 years of Pharmaceutical Experience Qualification : B.Pharm 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 mai...

Responsible for commercial batch release to market. Responsible for in process Quality Assurance activities. Responsible for In process Quality Assurance checks during Manufacturing, packing operations. Responsible for line clearance of manufacturing, Packing and dispensing activities. Responsible for assurance of cleaning, sterilization and aseptic manipulations of components. Responsible for Sampling of Cleaning Validation & Compilation of the records. Responsible for Sampling & compilation of Process Validation Reports (PVRs) Responsible for sampling and coordination during validation studies (process / cleaning validation). Responsible for routine monitoring of Manufacturing Areas. Good ...

Roles and Responsibilities Develop process designs, including P&IDs, flowsheets, and equipment sizing. Conduct process simulations using Aspen Hysys, Aspen Plus, or other relevant software tools. Collaborate with cross-functional teams to optimize processes for energy efficiency and cost reduction. Perform debottlenecking studies to improve plant capacity utilization and reduce bottlenecks. Participate in scale-up activities from lab to commercial production. Preparation of Process flow (PFD) & P&ID Monitoring the Process validation batches as per cGMP Experience on Solvent recovery and re use Experience on Process time cycle reduction Equipment mapping and suitability as per the process Mat...

Roles and Responsibilities Conduct quality control activities such as BMR reviews, stability studies, process validation, and equipment qualification. Ensure compliance with cGMP guidelines and regulatory requirements through IPQA activities. Investigate deviations and CAPAs to maintain product quality and prevent recurrence of issues. Collaborate with cross-functional teams for change control processes and batch manufacturing record (BMR) review. Perform analytical testing using HPLC/GC/UV methods to ensure product purity. Desired Candidate Profile 2-7 years of experience in API manufacturing or bulk drug industry only male candidate. MS/M.Sc(Science) degree in Chemistry or related field; ....

Strong Online Testing & Analysis knowledge Strong Sampling & Methodology knowledge Instrument Calibration & Validation Documentation & Label Method Development & Validation Strong SOP & QMS Compliance Candidates from Herbal/Phyto industry is required

Position will be responsible for Maintenance and Adherence of Corporate QA function basically ISO 9001 and Quality Management System EHS standard sustenance . Key Responsibilities and Deliverables. 1. Ensure and oversee the development, implementation, and ongoing maintenance of all necessary QMS and EHS system. 2. QMS Performance: Report on the effectiveness of the QMS, identifying areas for improvement and necessary actions. 3. Promoting Customer Requirements : Ensures that customer requirements are communicated effectively throughout the organization, fostering a customer-centric culture. 4. Coordinating Internal/ External Audits: Coordinates the planning and execution of internal audits ...

Seeking a dedicated QA Personnel for our Pharma Plant to ensure compliance, quality, and safety. Must have skills in Risk Management, Tools & Techniques, Training & Development, and Process Validation & Improvement. Required Candidate profile 10+ yrs in QA. Maintain QMS per GMP & regs. Review docs/SOPs, batch records. Train staff. Use automation for API, functional & performance testing to boost quality & efficiency

Position: Manager Quality (QMS) Experience: 8 to 14 years Location: Kurla, Mumbai Qualifications: B. Pharma / M. Pharma / M.Sc (Chemistry) Shift Time : 5 PM- Midnight Work Model : Hybrid (3 WFO+ 2 WFH), later can change Industry Preference: OSD and API plant Key Responsibilities & Required Experience: In-depth knowledge of Quality Control investigations including OOS, OOT, Lab Incidents, and Deviations Expertise in Root Cause Analysis and Risk Assessment Hands-on experience with analytical instruments and various QC techniques Proficient in drafting Quality Technical Agreements (QTA) Skilled in compendia assessments , data trending , Annual Product Quality Review (APQR) Exposure to Process V...

Glowria Lifecare Pvt. Ltd. is looking for QA Officer to join our dynamic team and embark on a rewarding career journey. Develop and implement quality control processes and procedures.Conduct audits of production processes and facilities to ensure compliance with regulations and quality standards.Develop and maintain documentation related to quality control activities.Investigate and resolve quality issues, working closely with production, engineering, and other departments.Develop and maintain product or service specifications, quality plans, and procedures.Monitor and analyze quality data to identify trends and opportunities for improvement.Train employees on quality control processes and p...

About Amgen Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning cultur...

Candidate should have experience on activities listed below but not limited to Scale up of process from Lab to Pilot to Commercial. Process validation of new molecules for regulatory filings Process validation of Cost Improvement Processes Yield and Capacity Improvement. Root Cause Analysis for OOS/OOT and Identification of appropriate CAPA Preparation of Investigation Reports. Process Hazard Analysis and Hazop studies preparation. Selection of Equipment Documentation related to Process Engineering activities like PFD, P&ID, Hazop, FMEA etc.. B. Tech , Chemical Engineering

Key Roles & Responsibilities: 1. Oversee and support the overall activities during the product development life cycle from quality perspective in R&D (API and intermediates). 2. To understand the site needs with respect to system establishment and sustainability. 3. Author/ Review and approve the SOPs/work directions required for implementing the Quality systems in R&D activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions. 4. Review and approve Lab Familiarization Reports (LFR), Product development reports (PDR), Technology transfer, product specifications & STPs, analytical method validation, method transfer, qualification, calibration, ...

Job Description Performing In-process Checks at different stages of manufacturing and packing stages for various products during validation activity and ensuring the compliance. Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification. Review of master batch manufacturing record and batch packing record in SAP. Active participation in execution of qualification and calibration activity. Ensure the compliance of the SOPs and cGMP requirements in Qualification and validation. Ensuring the compliance of the SOPs and cGMP requirements at shop floor. Work Experience 2 to 4 years Education Graduation in Pharmac...