1740 Change Control Jobs - Page 4

Desired Competencies (Technical/Behavioral Competency) Must-Have** (Ideally should not be more than 3-5) Strong understanding of certification requirements for compliance for fully electrified vehicles including hardware and software Strong understanding of change management process for certification requirements in various markets Battery Electric vehicles certification test experience Hands-on experience in change control management for engineering changes for hardware and software and deployment of those changes for certification requirements Knowledge of Electric drive units / High voltage batteries / charging systems compliance standards Good-to-Have Bachelors degree in mechanical/ elec...

Skills Required: Graduate / PG in management With a minimum of 4 7 years of experience in managing the Admin function. Must have hands on experience into Advance Excel Key Responsibilities Making MIS Reports of collated data Meticulously working on the data collated from various sources of department and preparing comprehensive reports Ensuring the precision of the reports Preparing Delivery Files Extensive work on Excel Preparing necessary dashboards for day to day operations Monitor & analyses data for business trends & prepare monthly revenue & collection report Provide cross functional quality oversight from a compliance perspective fo testing and disposition, quality investigations, val...

JOB TITLE Technical Business Analysis Engineer II RESPONSIBILITIES May perform one or more of the following: Requirement/Analysis Ability to comprehend Business Requirement Documents (BRD) Maintain and Update Data/Vendor Interfaces BRD Interprets requirements to create systems specifications documents to build and execute system. Perform Data Analysis, Audit, and associated research and provide subsequent resolutions. Understanding of database/SQL Query Writing Work alongside with Sr. members or individually (as required) to assist in smooth integration/transition of processes and create/maintain documentations for the same. Responsible for solving the data and Vendor files related issues an...

experience in Vaccine or Biosimilar manufacturing Strong exposure to In-Process Quality Assurance & Quality Management Systems and review system Knowledge of GMP guidelines and documentation practices fast-paced, regulated environment Perks and benefits 5- days working, Pf , health insurance

Responsibilities: Ensure GMP compliant operations and robust Quality Management System (QMS) execution for API manufacturing at the Ankleshwar site, including documentation control, batch release support. Batch Documentation & Release: Review BMR/BPR, analytical reports, COAs; ensure compliance with specifications and data integrity (ALCOA+). QMS Ownership: Manage change controls, deviations, CAPA, OOS/OOT investigations with timely closure and impact assessment. Documentation Control: SOPs, specifications, STPs, protocols/reports; version control and archival as per GDP. Vendor & Material Quality: Support qualification, sampling, and release of RM/PM; review COAs and ensure traceability. Tr...

Responsibilities: Review and approve batch records, laboratory data, and other relevant documents related to the manufacturing process. Ensure all operations comply with GMP guidelines, FDA documentation requirements, and internal quality standards. Conduct internal audits to assess adherence to GMP, standard operating procedures (SOPs), and other regulatory requirements. Participate in the review and approval of finished product batch records and assist in product release processes. Investigate and manage deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out of Specification) results in a timely manner. Support the Quality Control Laboratory to ensure all testing is performed ...

protocol & reports of equipment / utility qualification Responsible for execution of equipment / utility qualification. process validation cleaning validation Annual Product review Validation Master Plan. Computer System Validation/ PLC validation Perks and benefits Food & Transportation, Bonus & Gratuity Separately

Job Title: EV Certification & Change Control Engineer Experience: 612 Years Location: Offshore / Remote Industry: Automotive – Electric Vehicle (EV) Job Description We are hiring an experienced EV Certification & Change Control Engineer to manage regulatory compliance and engineering change approvals for Battery Electric Vehicles (BEV) programs. You will be responsible for certification documentation, engineering change governance, and ensuring hardware & software compliance across global markets. Key Responsibilities Manage EV certification & regulatory compliance for global markets Handle engineering change control for EV hardware & software components Ensure legal compliance & documentati...

Job Title: Officer -QA Business Unit: Global Quality And Compliance Job Grade G12C Location : Gangtok 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: To give the line clearance as per BMR/BPR...

Perform logic modification activities,change control procedures,monitor and execute daily and shift based maintenance activities,handle instument breakdown and records, Annual Maintenance Contract like Telephone, DCS, Camera and Smoke Detectors. Required Candidate profile Experience of 1-5 years in Yokogawa DCS and PLC Systems (Siemens & Schneider)

(QMS) implementation, Manage Change Control, Deviations, and CAPA to maintain product quality. Conduct Vendor Qualification & audits. Ensure GMP practice. Stability Studies & ensure compliance with ICH guidelines. Time Studies & process optimization.

Responsible for executing and involving in plant activities. Update the documents likes Batch Manufacturing record, equipment cleaning record, daily checklist in online. Follow the standard operating procedure while performing the activities. Follow the In-charge instructions and execute the batches as per production plan. Before starting the batch, ensure the raw materials quantity availability and the packing intactness. Before the process ensure the equipment conditions to inline the operating procedure and process requirements. Any discrepancies observed in the process, procedure or safety should be reported immediately to the relevant reporting authority. Coordination with service depar...

Job Responsibilities To ensure Sit Ready for anytime Regulatory Inspection in Compliance to cGMP Norms of Various Regulatory Bodies. To train personnel on cGMP, regulatory expectations, and quality systems to enhance compliance and awareness. To ensure Vendor Qualification activities are conducted as per SOPs, and maintain an up-to-date Approved Vendor List and requalification of Vendor Schedule. To ensure Quality Assurance, Quality Control, Microbiology, Production, Warehouse, Engineering activities are performed in compliance as per current GMP requirement and their effective implementation. Responsible for ensuring QMS elements (Change Control, Deviations, CAPA, OOS, OOT, etc.) are implem...

JOB DETAILS 1.Planning and execution of work related to Q.C. 2.Responsible for reviewing & implementation of SOP related to Quality control department 3.Responsible for approval / Rejection of Raw Materials / Packaging Materials / Intermediates. 4.Release results of Finished product. 5.To ensure that all testing are carried out as per appropriate standard specification. 6.To verify the correctness of results and testing of the analyst also to validate the analyst skill and maintain its records. 7.Responsible for approving sampling instructions, specifications, test methods and other quality control procedure. 8.To train the new analyst for the day - to - day activities and documentation. 9.R...

We are seeking a detail-oriented and experienced Manager, Quality Assurance to lead our QA team and ensure the highest standards of quality across products, processes, and services. The QA Manager will be responsible for developing and implementing quality assurance policies, conducting audits, analyzing data, and collaborating with cross-functional teams to drive continuous improvement. Key Responsibilities: Lead and manage the Quality Assurance team, including hiring, training, and performance management. Develop, implement, and maintain QA standards and procedures in accordance with regulatory requirements and best practices. Monitor and report on quality metrics, identifying areas for im...

Role & responsibilities Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. What You Will Achieve In your role, you will help us in investigation of any quality issues in manufacturing and quality laboratories. You will work with a team to investigate deviations and out-of-specification results and atypical result investigations....

Responsibilities: Oversee the generation, review, and archival of documents used to support Good Manufacturing Practice manufacture of Final Product. Review of raw material related documentation and release of raw materials Provide quality support for the development of appropriate Corrective and Preventative Actions (CAPAs) Provide advice to departments regarding GMP compliance Review and approve QA controlled documentation such as SOPs, batch records, working instructions Assessing change control requests on consistency, relevance, GMP compliance and clarity Assist with writing, revising, and approving standard operating procedures. Review and preparation of batch release documentation Sup...

Responsibilities: Operate and monitor vial filling, sealing, and washing machines in the injectable section. Ensure aseptic conditions are maintained during all operations in the cleanroom. Perform routine cleaning and sterilization (SIP/CIP) of equipment. Handle line setup, changeover, and minor troubleshooting of filling machines. Record batch manufacturing and equipment log sheets as per GMP guidelines. Follow safety and quality standards as per regulatory requirements (cGMP, WHO, etc.). Coordinate with maintenance and QA for smooth production activities. Required Skills: Logical thinking. Organizing. Good in communication. Required Qualification: - ITI/D.Pharm/B.Pharm

Role & responsibilities 1 Preparation of standard operating procedure. 2 Preparation of quality documents. 3 Initiate / review of change control system. 4 Initiate / review of deviation. 5 Initiate / review of CAPA. 6 To control, issue, retrieve, retention and disposal of GMP documents as per standard procedure. 7 Review of MFR/BMR/BPR/ECR. 8 Review of validation protocols and report. 9 To participate in investigation of OOS for RM/intermediate/FP. 10 To participate in market complaint handling. 11 Review of vendor qualification documents. 12 Review of executed manufacturing and analytical records. 13 Preparation of annual product quality review. 14 To take plant round and ensure compliance ...

Job Description Job Responsibilities: Works under general direction. Independently determines and develops approach to solutions. Contributes to a project of considerable significance or leads smaller scope projects. Supports material/design/packaging/process changes to the product line through design control process, with well documented research/analyses. Demonstrates accountability for successful and timely completion of designated tasks. Develops technical solutions to complex problems using sound engineering principles, utilizing experimental, computational, and analytical methods. Designs and develops in vivo and in vitro models to evaluate product/packaging features and improvements. ...

Competent in design and planning Familiar with construction and project management processes Ability to produce detailed drawings and specifications Assist in the development of architectural projects Collaborate with senior architects and project teams Prepare and modify architectural documents and drawings Show more Show less

As an Executive - QA (API - Pharma) at our manufacturing unit in Tumkuru, your responsibilities will include: - Handling QMS activities such as change control, deviations, CAPA, returned goods, and market complaints. - Preparation and review of all SOPs. - Monitoring online GMP activities in various departments. - Preparation of audit documents and active participation in audits. Qualifications required for this role: - 2-5 years of relevant experience in a similar position in the pharmaceutical industry.,

As a Production Manager, you will be responsible for planning, organizing, coordinating, and controlling production activities according to the monthly production plan. Your role will involve monitoring and controlling the manufacturing department to ensure efficiency and quality standards are met. Your key responsibilities will include: - Investigating complaints, recording deviations and incidents, suggesting change control processes, handling non-conformance, returned goods, product recalls, vendor audits, and external testing laboratories audits. You will also be responsible for assessing their impacts, reviewing reports, and monitoring the implementation of Corrective and Preventive Act...

As an Executive/Senior Executive in the R&D Quality-CMC QA department at Gurugram location, your role involves the following responsibilities: - Review various R&D documents including stability data, analytical reports, method qualification reports, method verification reports, method validation protocols & reports, working standard / impurity standard profile, analytical data of pilot bio batches, and method transfers protocol & report. - Review lab events, deviations, change controls, CAPA, and associated investigation reports before Technology Transfer. - Support and actively participate in failure investigations, identifying root causes for issues related to systems and products develope...

As a Quality Assurance Officer in the Pharma background, your role is crucial in maintaining the quality standards and regulatory compliance within the company. Your main responsibilities include: - Maintaining quality training requirements in compliance with FDA and other regulations. - Keeping up-to-date training records and updating training programs as necessary. - Designing training programs for both new and existing employees, from implementation to evaluation. - Proactively interacting with a wide range of employees to conduct training programs, support product launches, and enhance programs. Your skills should include: - Ensuring GMP & regulatory compliance, SOPs, and Change control....