807 Process Validation Jobs

Lead supplier development strategy by collaborating with vendor development team Develop the quality metrics to monitor the supplier quality performance Support new product launches to ensure that supplier quality meets the required standards Perform supplier process validation audits as per IATF 16949 or VDA 6.3 standards Conduct `Supplier Quality meet workshops to enforce the quality requirements Team up with suppliers on the value enhancement opportunities in the manufacturing processes Review supplier manufacturing capabilities in line with BorgWarner supplier quality manual Should possess strong analytical problem-solving skills through QC approach Hands on experience in Six Sigma/Shain...

Job Descriptions : Knowledge on CNC 3AXis and 5 Axis machining PPAP APQP Documentation Knowledge on GDT and Quality inspection methods Solidworks Proficiency (Advanced modelling and assembly) Shop floor Knowledge(Toolings, Fixtures, Jigs and Work holdings) Proficiency in Microsoft Office 365 DFM Analysis Knowlegde on selection of tools and Fixtures Knowledge on Process validation Coordinate with production, quality and procurement teams to gather necessary data for project excecutions.

Key Responsibilities: cGMP Implementation & Documentation Formulate systems for effective implementation of cGMP across the facility. Ensure preparation, approval, and implementation of: Standard Operating Procedures (SOPs) Standard Cleaning Procedures (SCPs) Specifications Standard Test Procedures (STPs) Cleaning validation protocols Stability protocols Master batch production records (MBPR/MFR) Ensure timely issuance, revision, review, control, and retrieval of documents. Cleaning Validation Prepare cleaning validation protocols, product matrix, and MACO calculations. Prepare cleaning validation summary reports. Prepare clean equipment hold-time and dirty equipment hold-time protocols and ...

Job Title: Sr.Manager (QA-QMS) Business Unit: Global Quality & Compliance Job Grade G9B Location : Poanta At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: Investigation and overall handling of ...

IPQA To perform line clearance activity at the relevant stages of the process i.e. dispensing, manufacturing, and packing. To perform online in-process activities during manufacturing and packing activities, adhering to the approved BMR/BPR SOPs and immediate reporting of any deviation from approved procedure to the supervisor. Responsible for sampling activity and send samples (either through LIMS or manually) as per the respective sampling plan to the quality control unit for routine batch analysis from the respective stage, retest samples, process validation samples, hold time study samples, and cleaning validation samples. To perform AQL activity at core/coated stage of products. Executi...

To plan operational activities and ensure robust and trouble free transfer of manufacturing process technology for pharmaceutical Sterile dosage formulations (Pre-filled Syringes (PFS), Cartridge in Pen device, Vials, Ophthalmic etc) developed at the Drug Development Research Laboratory (DDRL) to the designated Receiving Unit (RU) inline with project time lines, all the while adhering to cGMP, GDP and other applicable norms and guidelines Key Responsibility Areas: A) Assessment Batches: 1. Calculate the batch size according to the feasibility of Receiving Unit (RU) equipment chain and the manufacturing process. 2. Ensure availability of Test license, cleaning method, SAP codes and vendor qua...

Job Title: Executive - MSTG Nosd Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location Baroda At Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Key Responsibilities: Responsible for the MSTG-NOSD activity related Technology t...

Roles and Responsibilities Prepare and maintain accurate records of quality documents, including SOPs, CAPAs, Change Controls, Deviations, Market Complaints, Process Validation protocols, and Audit Documentation. Ensure compliance with ISO documentation requirements for Quality Management System (QMS). Desired Candidate Profile 4-8 years of experience in a pharmaceutical industry setting with expertise in QMS implementation. Bachelor's degree in Pharmacy (B.Pharma) or Science (B.Sc) from an accredited institution. Strong understanding of Good Manufacturing Practices (GMP), Current Good Laboratory Practice (cGMP)

Job Description: Study product drawings & propose manufacturing process sequence Prepare investment & process costing for new projects/ revisions Conduct DFM with R&D and provide inputs to maintain/ improve manufacturing standards Prepare and verify PFD, PFMEA along with CFT Prepare and monitor NPD development schedule for JFG & Equipment along with Cluster ME Head Sign- off machine specifications along with Maintenance, Production & QA before sharing with suppliers Sign- off test bench specifications along with R&D & Maintenance before sharing with suppliers 8. Validate Civil and MEP requirements for NPD projects. Coordinate with Civil team for capex requirement Raise Capex in system for NP...

Job Description: Study product drawings & propose manufacturing process sequence along with product lead Participate in DFM with R&D and provide inputs to maintain/ improve manufacturing standards Prepare PFD, PFMEA and sign off with CFT Execute activities as per NPD development schedule defined by Product Lead and Cluster ME Head Prepare machine specifications as per model line and sign off with CFT Prepare test bench specifications along with R&D & Maintenance before sharing with suppliers Define Civil and MEP requirements for NPD projects. Arrange quotations for NPD execution and review with Product Lead/ Cluster Head for Technical Recommendation Conduct concept review with suppliers and ...

Date & Venue of Walk-In Selection for Jaipur, Rajasthan Location: 01.12.2025, Hotel Rime Vista, Devi Marg, Bani Park, Jaipur. Date & Venue of Walk-In Selection for Unnao, Uttar Pradesh: 03.12.2025, Hotel Geeta Garden, Opp. Power House, Murtaza Nagar, Dahi Chauki, Unnao. Details of the Requirement are as follows: Graduation in Science or Diploma in Engineering with Minimum 3+ years of experience in QA functions in sanitary napkin / hygiene product / FMCG / medicaldevice / pharmaceutical manufacturing units.

JOB DESCRIPTION: Work Experience : 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 & receiving site in process & equipment and ...

Experience:3+ Years Skill: Process Validation Engineer Notice Period: Immediate Employment Type: Contract Work Mode: WFO/Hybrid Job Description : Good in documentation ( E.g. GDP , in earlier exp if person is author of doc and worked in regulated industries like Medical device , Pharma & Aero space etc) Experience with statistics Effective communication to have proper discussion (exp in handling manufacturing activities) Hands-on mentality to perform PV related activities (e.g TMV, IQ, OQ & PQ) Hands on shop floor is preferable Perform gap assessment and conduct remediation of documents with stakeholder inputs. Good understanding on the manufacturing specific QMS documents for Class-I, II an...

Experience: 5 to 10 years in QA . Qualification M Pharm or B.Pharm Review and approve development protocols , reports , and technical documents for formulation, analytical, and process development. Ensure development studies are conducted as per Good Documentation Practices (GDP) and QMS procedures . Oversee batch manufacturing records (BMR/BPR) and analytical data for R&D and scale-up batches. Participate in formulation and analytical strategy meetings to ensure quality alignment. Development SOPs and related quality documents. Master formula records and batch manufacturing records. Analytical method validation and verification protocols. Evaluate and assess changes raised during developmen...

Job Title: Executive – MSTG Nosd Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key Responsibilities: Responsible for the MSTG-NOSD activity re...

Roles and Responsibilities Conduct process simulations, modeling, and optimization studies to improve plant performance. Collaborate with cross-functional teams to identify areas for improvement and implement changes. Provide technical support during scale up activities from lab to commercial production. Ensure compliance with safety regulations and industry standards throughout the technology transfer process. Desired Candidate Profile 1-6 years of experience in Process Engineering or related field. B.Tech/B.E. degree in Chemical or MS/M.Sc(Science) degree in Chemistry. Strong understanding of process planning, design, operation, and control principles.

Role Overview: You will be responsible for monitoring the Loan License Site located in Navi Mumbai, specifically focusing on IPQA/Shop floor activities related to Tablets, Capsules, Oral Liquids, External and Sterile formulations. Your role will involve overseeing quality at Loan License Sites, conducting FG inspections, reviewing batch records, and ensuring batch releases. Additionally, you will be involved in site pre-assessment for regulatory inspections, investigation of non-compliance issues, and review of COA and analytical data before releasing finished products. Key Responsibilities: - Monitor IPQA/Shop floor activities for various formulations - Provide quality oversight at Loan Lic...

Job Description Monitoring of Contract manufacturers of Consumer products across India. Quality Oversight at Contract manufacturing sites of Consumer products. Overall responsible for monitoring of Quality compliance at Consumer Sites across India. FG Inspection, Review of batch records and Batch releases Review of Finished product related data to support new Third Party Launch Monitoring of all shop floor activities IPQA Checks of Consumer products Lozenges, Toothpaste, Food, Nutraceutical products, Handwash, Sanitizer, Balm, Inhalers etc. Responsible for investigation of non-compliance with Contract manufacturer. Process Validation and Stability study execution and data review APQR prepara...

Job Description: Study product drawings & propose manufacturing process sequence Prepare investment & process costing for new projects/ revisions Conduct DFM with R&D and provide inputs to maintain/ improve manufacturing standards Prepare and verify PFD, PFMEA along with CFT Prepare and monitor NPD development schedule for JFG & Equipment along with Cluster ME Head Sign- off machine specifications along with Maintenance, Production & QA before sharing with suppliers Sign- off test bench specifications along with R&D & Maintenance before sharing with suppliers 8. Validate Civil and MEP requirements for NPD projects. Coordinate with Civil team for capex requirement Raise Capex in system for NP...

Study product drawings & propose manufacturing process sequence along with product lead Participate in DFM with R&D and provide inputs to maintain/ improve manufacturing standards Prepare PFD, PFMEA and sign off with CFT Execute activities as per NPD development schedule defined by Product Lead and Cluster ME Head Prepare machine specifications as per model line and sign off with CFT Prepare test bench specifications along with R&D & Maintenance before sharing with suppliers Define Civil and MEP requirements for NPD projects. Arrange quotations for NPD execution and review with Product Lead/ Cluster Head for Technical Recommendation Conduct concept review with suppliers and facilitate DAP si...

Study product drawings & propose manufacturing process sequence along with product lead Participate in DFM with R&D and provide inputs to maintain/ improve manufacturing standards Prepare PFD, PFMEA and sign off with CFT Execute activities as per NPD development schedule defined by Product Lead and Cluster ME Head Prepare machine specifications as per model line and sign off with CFT Prepare test bench specifications along with R&D & Maintenance before sharing with suppliers Define Civil and MEP requirements for NPD projects. Arrange quotations for NPD execution and review with Product Lead/ Cluster Head for Technical Recommendation Conduct concept review with suppliers and facilitate DAP si...

Responsibilities: Lead and manage the QA department to ensure high-quality product delivery. Develop and maintain QA standards, and best practices. Having Knowledge of preparing sops of all departments. Drive continuous QA functions. Provident fund

Your future role Take on a new challenge and apply your manufacturing and process engineering expertise in a cutting-edge field. Youll work alongside driven and collaborative teammates. You'll define manufacturing processes and associated equipment for new products, ensuring alignment with industrial policies and project constraints. Day-to-day, youll work closely with internal teams like Product Design Engineers, Manufacturing, Sourcing, Supply Chain, and Industrial Quality, as well as external stakeholders such as central teams and other site Industrial Data Managers. Youll also lead a team to drive and execute projects, ensuring industrial deliverables are met on time. Youll specifically ...

What will you do: Primarily responsible for Risk management and risk assessment as per ISO 14971, Risk Table creation & Analysis, FMEAs, Quality Plan, Literature Review, Device Master Record, Quality Training Plan and Technical File. Primary participant in new supplier selection, validation, and contract development. Assists vendors in resolving manufacturing and quality issues as required. Partners with the operations team to develop and maintain a robust internal and external supply chain. Develop procedures for incoming, in-process and final inspections for new product development Assists/Leads in the trending and analysis of quality data (e.g. complaints, scrap, warranty return rate, etc...

Your future role Take on a new challenge and apply your **supplier quality management and industrial process validation** expertise in a cutting-edge field. Youll work alongside **dedicated and innovative** teammates. You'll ensure that our supplier processes and product developments meet the highest quality standards, contributing directly to Alstom's commitment to excellence in mobility solutions. Day-to-day, youll work closely with teams across engineering, production, and supplier management, **validate supplier processes** and **drive continuous improvement initiatives**, and much more. Youll specifically take care of **product development validation** and **supplier industrial process ...