449 Process Validation Jobs - Page 6

About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watch?v=tASq7Ld0JsQ About the Role: We are looking for experienced Test automation engineers/SDETs who could join our cloud product engineering team to build the next gen applications for our global customers. If you are a technology e...

Responsible for QA functions-legal documentation, Compliance of QA/ISO/EHS systems/insecticides rules, Analysis, Timely, accurate & cost effective analytical support to plant, preparing SOP/Verification of testing methods, Instruments calibration etc Required Candidate profile M.Sc.with 3 to 6 yrs relevant exp in Agrochemical industry. Knowledge of quality systems, in house calibration of lab instruments , handling of QA lab Instruments , Root Cause Analysis Techniques etc.

Job description Position : Assistant Manager - Technical Position Reports to : Direct Line : Senior Manager - Process & Product Improvement Dotted Line : General Manager Department : Technical & CIBB Location : Jigani, Bangalore India General Summary of Position : Reviewing organization&aposs operating mechanisms, test process effectiveness and ensure that outcome meets operating requirements in the short and long terms. Responsible for all process validation aspect within process improvement of NRL&PI Collaborate with production personnel, R&D and manufacturing Manager for production, NR & PI to control and improve operating processes via continuous improvement. To provide and improve techn...

Perform line clearance activities prior to production operations. Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and Batch Filling Records (BFR). Execute in-process QA checks and verifications during manufacturing and packaging. Manage control sample collection, storage, and documentation. Collect in-process, finished product, and customer complaint samples as required. Compile Annual Product Quality Review (APQR) data and perform trend analysis. Participate in process validation, hold time studies, and related quality activities. Coordinate with relevant departments for timely batch release. Conduct routine GMP checks in production, warehouse, and other relevant depa...

Preferred candidate profile 1. Expose to injection facility 2. Qualification of equipment 3. Process Validation 4. Media Fill 5. IPQA activity 6. QMS & other documentation

You should have a background in B.Pharma / M.Sc. and preferably from the Pharma industry. It is mandatory to have experience in both Sterile & Non-Sterile processes. Experience in Regulatory markets such as USFDA, MHRA, EU is required, with USFDA being the first preference. The offered CTC for this position is 30 LPA and a minimum of 15 years of experience is necessary. Both male and female candidates are welcome to apply. Your responsibilities will include having a strong understanding of Cleaning Validation, Process Validation, Equipment Qualification, and Computer System Validation. You will be in charge of managing 4 units within the Indore Site. Strong team management and communication ...

You will proactively assess quality issues and ensure compliance to QA/QC as per regulatory requirements in manufacturing operations and quality function at the site by keeping track of quality metrics. You will ensure the site is always ready for regulatory/statutory inspections/internal audits and regularly monitor the performance of each individual in the Quality department. You will facilitate internal and regulatory agency audits, ensuring findings from site audits are understood, assessed, and addressed comprehensively. Moreover, you will ensure the closure of audit observations by reviewing the CAPA and driving its implementation. Implementation of requisite changes at the plant level...

As a Product Supply Manager at Procter & Gamble, you will have the opportunity to work with cutting-edge technologies and standards that are globally recognized. Your role will involve leading a team to identify and eliminate losses through process and organization capability development using manufacturing tools. You will also be responsible for standardization, equipment changes, process validation, and technical troubleshooting of process failures. On a daily basis, you will set the direction for the team, report results, address issues, and request necessary resources. Your focus will be on reducing costs, driving productivity projects, and optimizing asset utilization through benchmarki...

You will be responsible for performing In-Process Quality Assurance (IPQA) activities on the shop floor at every stage of manufacturing and packing processes. This includes ensuring QA standards for clean room behavior and activities, reviewing batch processing records, and checking all documents related to manufacturing, packaging, and analysis reports before batch release. You will also be required to review documents, logbooks, and conduct IPQA for Dispensing, Manufacturing, Packaging, and Dispatch activities. As part of your role, you will review and control Standard Operating Procedures (SOPs), specifications, Batch Production Records (BPR) issuance, Master Formulae, and records. Additi...

You will be responsible for the new product development cycle, from product design to delivery to the customer. This will involve conceptualizing the product, creating engineering drawings, defining specifications, designing the processes, packaging, and verifying and validating the product. You will also be required to prepare and share documentation with customers, as well as other external and internal stakeholders. Your role will include continuously working on improving product quality and optimizing processes and materials to ensure competitiveness in the market. You will be responsible for strategizing innovative products while collaborating with cross-functional teams. Additionally, ...

We are seeking a highly motivated and detail-oriented Quality Management System (QMS) professional to join our Quality Assurance team at Mendine Pharmaceuticals Pvt Ltd. As a part of our team, you will play a crucial role in ensuring compliance with regulatory requirements and company standards by implementing and maintaining effective quality management systems. Your responsibilities will include managing various quality-related activities such as quality risk management, batch manufacturing record preparation, process validation, deviation management, and more. In your role, you will be expected to identify, assess, and mitigate quality risks associated with products and processes. You wil...

As a member of the product development team, you will be responsible for conducting literature searches, gaining a deep understanding of the product, and interpreting data for further development. Your role will involve designing primary product strategies and preparing them for discussion with group leaders or team leaders. You will be involved in planning and executing product development work to achieve the desired product profile, as well as compiling relevant data. In this position, you will be responsible for executing and evaluating various formulation optimization trials and process optimization trials, while also compiling the resulting data. Additionally, you will be required to ma...

Job description: About the team: ZF&aposs Commercial Vehicle Solutions (CVS) division helps shaping the future of commercial transportation ecosystems. Our mission is to be the preferred global technology partner for the commercial vehicle industry. What you can look forward to as Assistant Manager/Senior Engineer: Participate in cross functional team to optimize manufacturing process and Process Engg for new product development projects. Lead in developing new machine, processes & installation etc. Know-how of types of sensors, its application and knowledge of pneumatics required. Preparation of process documents PFMEA, PFD, CP & WI, driving process parameter through process validation. Pro...

The Manager Quality Assurance position involves collecting, analyzing, and presenting data related to goods receipt rejection, line rejection, and rework to generate action points for continual PPM reduction. You will be required to prepare CAPA (Corrective and Preventive Action) 8D, Why-Why Analysis, and Cause and Effect Diagrams. Additionally, you will assess the implementation of Quality Plans and Quality Control Plans. Your responsibilities will include reducing in-house rejection/rework and developing action plans if defined goals are not met. Motivating employees to maintain high-quality work and ensuring safety protocols for operators will be crucial. You will also implement correctiv...

The ideal candidate for this position will join our R&D/F&D team focusing on Oral Solid Dosage (OSD) forms, including pellets and tablets. You will be responsible for conducting pre-formulation and formulation development studies, process validation, stability studies, and technology transfer of new pharmaceutical products while ensuring adherence to ICH guidelines and internal SOPs. Your key responsibilities will include conducting detailed literature reviews to support new product development initiatives. You will evaluate reference products, patents, regulatory status, and formulation strategies. Additionally, you will perform physicochemical characterization of API and excipients, assess...

The Senior QA Executive plays a crucial role in overseeing various aspects of quality management within the organization. This includes but is not limited to document control, compliance monitoring, internal audits, quality metrics tracking, and non-conformance management. The position also involves contributing to change control, supplier evaluation, risk management, product and process validation, complaint handling, CAPA support, and quality improvement projects. A key part of the role is to engage in data entry, analysis, and report preparation to ensure alignment with quality and compliance objectives. Responsibilities of the role include: - Document Control: Assisting in the organizati...

We are looking for a candidate to oversee manufacturing and production operations, managing equipment, process validation, handling change controls, deviations, incidents, and ensuring compliance with regulatory audits. Responsibilities include creating SOPs (Standard Operating Procedure), providing training, and applying expertise. Roles & Responsibilities You will be responsible for handling line operations, specifically production and manufacturing activities like CIP (Cleaning-in-place), SIP (Sterilizing-in-place), and batch manufacturing. You will be responsible for handling equipment like Steam Sterilizer, Dry heat sterilizer, HVAC (Heating, Ventilation, and Air Conditioning), water sy...

We are seeking a Technology Transfer team member to support the development and implementation of robust manufacturing processes, including authoring validation protocols and reports, conducting risk assessments, and utilizing advanced tools for process monitoring and analysis. Your role will involve active participation in technology transfers, continuous improvement initiatives, and ensuring compliance across manufacturing operations. Roles & Responsibilities Responsible for Validation which shall include:Preparation/Review/Approve of MPR.Preparation/Review/Approve of process validation protocols. Preparation/Review/Approve & compilation of validation report. Responsible for Tech transfer ...

Dr Reddys is seeking Manufacturing specialist specializing in cell therapy (CAR-T) programs. This position is part of our Manufacturing facility. The manufacturing role serves as a Specialistin CAR-T production facility. You will work closely with our Research and Product Development teams to support the GMP Manufacturing operations, Technology transfer, quality assessments, and supply chain logistics and process validation of the CAR-T process across a wide range of novel modalities for Cell therapy programs. Role Responsibilities: As a Manufacturing specialist, a typical day might include the following: Design and execute experimentation to develop robust manufacturing processes for cell t...

The job involves conducting literature search, enhancing product understanding, and interpreting data for product development. You will design primary product strategies and prepare them for discussion with group leaders or team leaders. It is important to plan and execute product development work effectively to achieve the desired product profile and compile relevant data. You will be responsible for scheduling work plans in consultation with group leaders or reporting authorities to ensure timely project completion based on assigned priorities. Additionally, the role includes executing and evaluating various formulation optimization trials, process optimization trials, and compiling data. ...

The position is based out of Chennai and does not offer a remote work option. The salary offered is between 5-8 lacs CTC based on validation experience. At Quascenta, we specialize in providing comprehensive validation lifecycle management software solutions. Our mission is to empower pharmaceutical manufacturing sites by offering software tools to streamline product manufacturing and cleaning processes, ensuring compliance, efficiency, and savings. Our flagship products, such as eResiduePro, eProcessPro, and eLogBook, aim to transform how companies manage their product, process, and cleaning lifecycles. With over 20 years of experience, our solutions help organizations meet regulatory requi...

As a maintenance engineer, your primary responsibilities will include maintaining facility and equipment, procuring engineering consumables and proprietary spares, and managing inventory. You will be responsible for performing and approving qualification studies for equipment and facilities, as well as scheduling and executing preventive maintenance programs for plant and utility equipment. Additionally, you will review and participate in process validation programs, update technical drawings such as plant layout and P & ID, and manage annual maintenance programs for utility and material handling equipment. You will also be involved in arranging instruments for plant equipment, ensuring comp...

As a dedicated Downstream Process Engineer, you will be responsible for analyzing the current downstream processes to identify bottlenecks and inefficiencies. Your expertise will be crucial in implementing effective strategies to enhance process yield, purity, and throughput. Leading a team of engineers and technicians, you will provide technical guidance and support to ensure optimal performance and foster a culture of innovation, collaboration, and continuous improvement. Your commitment to excellence includes ensuring compliance with all regulatory standards and quality control procedures. By implementing robust quality control measures, promptly investigating and resolving quality issues...

A QA Manager in the pharmaceutical industry is responsible for developing, implementing, and maintaining quality assurance systems and processes that ensure products meet regulatory standards and customer expectations. he

Ensure current versions of all GMP documents are in use. Prepare, revise, and control SOPs . Implement and enforce (GDP). Conduct internal audits, maintain summaries and CAPA tracking Support in process validation, equipment qualification etc Required Candidate profile Ensure all QA activities comply with cGMP, regulatory requirements & internal quality standards for API & Specialty manufacturing. Contact Mr Deep at 9867038868, Email Id: ops@empowerrecruitments.com