670 Process Validation Jobs - Page 7

Job Title: Manufacturing Engineer Medical Devices (Senior/Principal Level)(Remote) Location: Hyderabad, IND Employment Type: Part-time Position Summary: We are seeking an experienced Manufacturing Engineer Trainer with 10-15+ years of hands-on expertise in the medical device industry to support and enhance our manufacturing operations. The ideal candidate will have a proven track record in process development, validation, scale-up, and continuous improvement while ensuring compliance with FDA, ISO 13485, and GMP regulations . Key Responsibilities: Lead the design, development, and optimization of manufacturing processes for Class II/III medical devices. Drive process validation activities, i...

Overview The Automation Anywhere Robotics Bot Controller role is part of the Intelligent Automation (IA) or RPA Operations team and reports to the RPA Product Owner/Manager. The primary purpose of this position is to monitor, validate, and enhance robotic process automation (RPA) bots built on Automation Anywhere, ensuring consistent, high-quality output. The person will be responsible for addressing bot performance issues, managing bug fixes, and implementing optimizations to meet evolving business needs. This role involves collaborating closely with developers, business analysts, process owners, and IT teams to ensure that automation solutions operate seamlessly in production environments....

Roles & Responsibilities: Quality Oversight Supervise and implement quality control measures across manufacturing operations to ensure compliance with ISO 13485, FDA QSR, and other applicable regulatory standards. Conduct regular in-process and final inspections of products to identify defects and ensure they meet specifications. Manufacturing Process Monitoring Collaborate with manufacturing teams to monitor and control production processes, ensuring adherence to Good Manufacturing Practices (GMP). Review and approve manufacturing process documentation, including SOPs, work instructions, and validation protocols. Quality Systems Management Maintain and support the quality management system ...

Job Title Senior Manager - Engineering Business Unit Sun Global Operations Job Grade G9B Location : Halol 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 This role is responsible for overseeing all Block ...

As an MS&T Technology Transfer Specialist, you will lead technology transfers, optimize processes in commercial stage and improve producibility. You'll be the expert bridging development, production, and quality, ensuring compliance, patient safety, and operational excellence. Key Responsibilities: Lead technology transfers and new process introductions Support transfers and optimization of current processes Develop and maintain manufacturing documentation and risk assessments Technical support across the product lifecycle, including troubleshooting and process robustness Review and manage manufacturing documentation and regulatory compliance Drive innovation and continuous improvement in va...

Responsible for the MSTG-NOSD activity related Technology transfer of new products, site transfer products, commercial launches, LCM activities and CMO activities. Responsible for establishing new procedures, maintaining and updating existing procedures in the MSTG NOSD department. To co-ordinate with Cross Functional Team for execution of Trial, Scale-up, Exhibit, Process validation batches of new Products and commercial launch batches. Responsible for Support in regulatory Audit and Compliance & Query responses for Filed products. Handling & Support of Trouble shooting batches for data comparison and route cause Investigation for commercial products. Responsible for Review, comments and ap...

Experience in Vaccine/Injectable/Sterile manufacturing setup Review and evaluate facility, utility, process equipment & instrument design Prepare and review URS, DQ, FAT, SAT, IQ, OQ, PQ documents Conduct Computer System Validation (CSV) as per GAMP & 21 CFR Part 11 Coordinate with project teams to meet timelines and milestones Ensure compliance with GMP and regulatory standards Investigate deviations, failures, and non-conformances Identify root causes and implement CAPA Support audits and inspection readiness activities Job Location: Kadi, Gujarat ( Bus facility available for daily commute) Note: Immediate joiners will be preferred first

We have urgent Requirement for : Department : Quality Assurance Designation : Executive Skills Required : Process Validation, Equipment Qualification, QMS, APQR, Capa, Cleaning Validation. Experience Required : 03 to 08 years Salary : Depend upon Interview Location : Nalagarh interested candidate can contact @ 7717304694 or can send their Resume at hr2@theonpharma.com

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary A role-holder to handle/supervise the manufacturing activities and to ensure t...

Role Overview: As an MS&T Technology Transfer Specialist, you will lead technology transfers, optimize processes in the commercial stage, and improve producibility. You'll be the expert bridging development, production, and quality, ensuring compliance, patient safety, and operational excellence. Key Responsibilities: - Lead technology transfers and new process introductions - Support transfers and optimization of current processes - Develop and maintain manufacturing documentation and risk assessments - Provide technical support across the product lifecycle, including troubleshooting and process robustness - Review and manage manufacturing documentation and regulatory compliance - Drive inn...

IPQA activities;Process qualification;equipment validation;URS preparation;BMR/BPR review etc. QMS; Qualfication ansd validation of SVP; lyophilization; Risk assesment

Job Title: Senior Manager - Engineering Business Unit: Sun Global Operations Job Grade G9B Location : Halol 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: This role is responsible for oversee...

Job Title: Senior Manager – MSTG Non Orals Business Unit: R&D1 Regulatory Affairs Job Grade G9B/A Location : Halol 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.” Job Description: Responsible for the MSTG-NOSD acti...

To follow the SOP and implementation on current Good Manufacturing Practices(cGMP). Reviewing the online documentation like BPR/BMR, Log Books, in process Formats,during self-inspection and QMS related query. To maintain the GMP, personnel safety and hygienic practices on shop floor. Involved in Process Validation of new products as well as revalidation of existingProducts, requalification of existing equipment. Ordering and inventory control of spare parts. Line clearance during batch change over(TYPE A) or product change over(TYPE B). Handling and supervision of dispensing, manufacturing and packing activities. Handling and manage manpower. Good knowledge of SAP. Supervision of manufacturi...

Job Description Position: QA Sterile Manager Department: Quality Assurance Designation: Manager - I Education Qualification: M.Sc. in Biotechnology / Microbiology / Chemistry Total years of Experience: 10+ Years Job Role: Management of Quality Assurance functions of Manufacturing Block P. Responsibilities Ensure that manufacturing and packing of the batch is executed and records are completed and reviewed in accordance with established SOPs and cGMP regulations. Conduct certification of batch production records for compliance and stage-wise completion. To release / reject the Batch after complete review of batch and related quality documentation. Tracking and monitoring of QMS system. Ensure...

Responsibilities: Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets. eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch. Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time submissions and publishing tasks. Manufacturing Docu...

To maintain facility and equipment. To procure engineering consumables, proprietary spares and to maintain inventory of the same. To perform and to approve Qualification studies for equipment (Plant and Utility) and Facility. To schedule and to execute preventive maintenance program for plant equipment and utility equipment. To review and to participate in process validation program. To maintain and to update drawing like plant layout, equipment layout, P & ID for equipment (Plant and Utility), HVAC system etc. To schedule and to execute Annual Maintenance Program for Utility and material handling equipment. To arrange instruments for plant equipment and accessories. To review, authorize and...

Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned To be well disciplined & maintain the same in the production department. To maintain the safety and housekeeping practices at work place. To ensure and follow good and online documentation practices. To ensure proper labeling procedure wherever applicable as per ...

Job Title: Calibration & Validation Trainer Pharma Industry Location: Remote Job type: Part-time Job Summary: We are seeking an experienced Calibration & Validation Trainer with 10+ years of expertise in pharmaceutical quality systems, equipment calibration, and validation practices . The role involves delivering high-impact training programs to professionals and fresh graduates, focusing on regulatory compliance, instrumentation, validation protocols, and audit readiness . The trainer will act as both a technical instructor and career enabler , ensuring participants gain hands-on knowledge aligned with industry standards (FDA, cGMP, ISO, ICH, GAMP5, 21 CFR Part 11). Key Responsibilities: De...

We are seeking a highly motivated QA Test Developer with 5 to 7 years of hands-on experience in test automation, primarily using Python and PyTest to work on containerized storage solution. The ideal candidate is enthusiastic about quality, has strong problem-solving abilities, and is ready to take ownership of their work in a fast-paced, collaborative environment. The candidate delivers assigned work of increasing scope and complexity with high quality and on time, applying learned skills, new technologies, and innovation to improve team code quality and quantity. Negotiates effectively, as needed, to deliver outcomes.. You will be part of a QA team responsible for ensuring the quality of o...

As a Validation / Qualification Executive at SWAMI GLOBAL, your role will be to ensure the quality and compliance of various systems and processes. You will be responsible for tasks such as computer system validation, process validation, quality control, and quality assurance. Working closely with cross-functional teams, you will ensure that all validation activities are completed in accordance with regulatory requirements. Key Responsibilities: - Execute computer system validation and process validation - Perform quality control and quality assurance tasks - Collaborate with cross-functional teams for validation activities Qualifications: - Expertise in Computer System Validation and Proces...

As a Quality Assurance Officer at Tajola, Mumbai, you will be responsible for the following: - Issuing all documents related to QMS, BMR, ECR, Specification, MOA, TDS, formats & SOPs controlled copy. - Preparing, reviewing, and distributing SOPs. - Reviewing Batch Manufacturing Record (BMR), Equipment Cleaning Record (ECR), etc. - Managing Change Control Systems, out-of-specification, deviations, etc. - Preparing the Annual Product Quality Review. - Monitoring process validation and cleaning validation activities. - Handling pre-dispatch activities of finished products. - Performing QA rounds and ensuring line clearance of equipment & area after product change over cleaning. - Reviewing anal...

Comprehensive knowledge of large-scale biotech manufacturing, covering both upstream ( fermentation) and downstream (purification ) processes. Excellence in documentation for batch records and process-related documents to ensure accuracy, traceability, and regulatory compliance. Proficient in cell bank management, including creation, storage, monitoring, and traceability for consistent production performance. Advanced understanding of Good Manufacturing Practices (GMP), regulatory standards (including FDA), and pharmacopeial requirements for biotech products. Strong communication, teamwork, and interpersonal skills to foster effective cross-functional collaboration and timely resolution of p...

About SAN Automotive SAN Automotive is a leading engineering company insheet metal stamping, heavy fabrication, and tool & die systems , serving top OEMs and Tier 1 suppliers in the automotive, construction equipment, and agricultural machinery industries . Our client portfolio includes Maruti Suzuki, Hero MotoCorp, Honda, JCB, Denso, Mitsuba, INEL, Kubota, and AGCO , reflecting our strong reputation for quality and precision. With modern press shops, fabrication lines, robotic welding, CNC bending, and tool rooms , we deliver robust solutions while adhering to IATF 16949, ISO 9001, and VDA standards . We are now looking for a Sr. Engineer / Engineer in Process Engineering & Production to st...

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.