1120 Change Control Jobs - Page 42

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 are looking for a skilled Validation Associate Analyst to ensure our Master Data Management solutions are of good quality , compliant and GxP validated . As a key contributor, you will collaborate closely with cross-fun...

HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission - to serve patients - drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager – Devices What you will do Let’s do this. Let’s change the world. In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery de...

Experience -5 to 8 Years Skill: Labware LIMS Developer (Migration Project Experience is mandatory) Location: Bangalore Candidate should hold a Bachelor's degree in a computer system, engineer or Technical graduation. 6+ years of working experience in Labware LIMS, Web Services (REST & SOAP). Proficient in all technical aspects of Interfaces development (SAP), LIMS Basics, preferably Labware LIMS, Subroutines, Instrument interfaces. Good knowledge on the Labware databases. Work on the backlogs, fixing the bugs, and working on the change requests. Work experience on the Labware Migration projects . Very good technical understanding and hands on experience with software development projects. Pr...

Job Description: 1.Handling of QMS related activities i.e., CAPA ,etc 2.Handling of Market Complaint with related investigation. 3.Preparation, review and implementation of SOPs. 4.Handling of Internal Audit and related activities. 5.Preparation and handling of Audit related activities. 6.Preparation of Audit Compliance Report. 7.Preparation of Documentation, i.e., COA, COO, MSDS, TD. 8.Calibration/Validation of Instruments.

Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.

Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applic...

Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applic...

Roles and Responsibilities Ensure compliance with IPQA guidelines and regulations during production processes. Conduct regular inspections of manufacturing areas, equipment, and documentation to identify deviations from SOPs. Implement change controls by reviewing changes, conducting risk assessments, and ensuring effective implementation. Monitor CAPAs (Corrective Action Preventive Actions) to ensure closure within specified timelines. Collaborate with cross-functional teams to resolve quality issues and improve overall process efficiency. Desired Candidate Profile 3-7 years of experience in pharmaceutical quality assurance or related field. Strong understanding of IPQA principles, GMP regu...

Confidence Petroleum is looking for Documentation Executive to join our dynamic team and embark on a rewarding career journey. Preparing and maintaining all types of documents, such as user manuals, training materials, and technical reports Ensuring that all documentation is accurate, complete, and up-to-date Collaborating with cross-functional teams to gather information and develop comprehensive documentation Reviewing and editing documentation to ensure consistency and readability Developing and implementing documentation processes and procedures Staying current with industry trends and best practices in technical documentation Managing document version control and ensuring that all docum...

Please download the comprehensive job description, including the position summary, specific responsibilities, and qualifications . APPLICATION DEADLINE: Applications will be reviewed as they are received, so interested candidates should apply immediately.

Lake Chemicals Pvt.Ltd., (Sterling Lab), is looking for Quality Control- Senior Executive to join our dynamic team and embark on a rewarding career journey Understand customer needs and requirements to develop effective quality control processes Devise and review specifications for products or processes Set requirements for raw material or intermediate products for suppliers and monitor their compliance Ensure adherence to health and safety guidelines as well as legal obligations Supervise inspectors, technicians and other staff and provide guidance and feedback Oversee all product development procedures to identify deviations from quality standards Inspect final output and compare propertie...

About: Sahajanand Medical Division Medical division is approved by state and central licensing authorities and it delivers efficient performance to meet specific requirements. The SLTL brand stents embody that bold spirit, offering a unique blend of our leading-edge technologies and time-tested engineering With Technical Collaboration & Patent Design, the company started indigenous manufacturing of Coronary products, in 2009. The company has a dedicated in-house R&D department approved by DSIR (Department of Scientific and Industrial Research). We believe that every product we make should stand for something. Something more than expected. And thats why we dont manufacture products for stereo...

Job Area: Finance & Accounting Group, Finance & Accounting Group > Internal Audit General Summary: Job Overview Qualcomm is a company of inventors that unlocked 5G - ushering in an age of rapid acceleration in connectivity and new possibilities that will transform industries, create jobs, and enrich lives. But this is just the beginning. It takes inventive minds with diverse skills, backgrounds, and cultures to transform 5Gs potential into world-changing technologies and products. This is the Invention Age - and this is where you come in. This is a unique opportunity to join Qualcomm"™s finance and accounting organization based in Hyderabad in the Corporate Internal Audit & Advisory Services...

Creation and Maintain relevant master data in the LIMS, Ensure that the integrity, reliability and performance of the LIMS is maintained. Address and resolve issues arising with the system in a timely manner Required Candidate profile Ready to work in Morning or General Shift To manage the QMS processes—including OOS investigations, Deviations, Incidents & Change Control & to ensure strict adherence to GDP & GMP within lab

Role & responsibilities Conduct in-process checks during various stages of sterile injectable manufacturing, including dispensing, compounding, filtration, filling, and sealing. Perform line clearance and area clearance before the start of manufacturing and packaging operations. Monitor aseptic practices and personnel hygiene compliance inside cleanrooms and controlled areas. Verify critical process parameters and environmental conditions during batch processing. Ensure compliance with SOPs, batch manufacturing records (BMR), and batch packaging records (BPR). Participate in visual inspection activities and oversee container-closure integrity checks. Monitor the usage and replacement of ster...

Role Summary: OSD Production QMS is responsible for ensuring adherence to quality standards within the production process. The role involves monitoring production activities, implementing quality control measures, maintaining compliance with regulatory requirements, and driving continuous improvement initiatives. Roles And Responsibilities Quality Compliance: Implement and monitor compliance with QMS standards Industry-specific standards. Conduct periodic audits of production processes to identify deviations and enforce corrective actions. Ensure all production processes align with regulatory and company quality standards. Documentation & Reporting: Maintain and update standard operating pro...

Position : Section Head - Batch Release QA Functional Area: QA Reports to: QA Head Grade: G9B Department: Quality Location: Halol (OSD) POSITION SUMMARY Responsible for IPQA activity and strategy in line with Sun Pharma Compliance, Product Quality Management objectives and Regulatory requirements. Responsible for planning and arranging for internal and external departmental support of quality assurance activities as directed in approved protocols, quality systems or Procedures. Identify and implement solution for improving existing site quality assurance systems and processes Involvement in co-ordination of activities for software like SAP HANA at plant Responsible for review and Approval of...

About The Role Roles and Responsibilities: Work experience of Accounts Payable/Procure to Pay Knowledge on GST, IGST, CGST, TDS, VAT Invoice Processing/Invoice audit/vendor payments experience must SAP end user experience in FI Module for Financial accounting is must. Advanced Excel, PPT, MIS report and other analytical reporting knowledge & experience is an added advantage. Knowledge about different kind of payment methods and payment term. PO and non PO invoices handling ? ? ? ? Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career...

Role & responsibilities To carry out investigations related to OOS, OOT, Incident and Extraneous Peaks to ensure their closure and implementation of CAPA. Responsible for execution of Regulatory Notification as per SOP. To ensure implementation of all proposed actions identified as a CAPA of investigations related to OOS, OOT, and incident. Review of investigation reports, hypothesis protocol and hypothesis reports related to OOS/OOT and Incidents. Co-ordination with R&D, Production, Central Cell, CQA and other responsible for investigations. To prepare and review Quality documents such as (but not limited to) protocols, reports, SOPs STPs Specification, Investigation. Preferred candidate pr...

Seeking a IPQA Executive to ensure skincare products meet regulatory, safety, and 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

Design, develop, troubleshoot and debug software programs for databases, applications, tools, networks etc.As a member of the software engineering division, you will assist in defining and developing software for tasks associated with the developing, debugging or designing of software applications or operating systems. Provide technical leadership to other software developers. Specify, design and implement modest changes to existing software architecture to meet changing needs.Duties and tasks are varied and complex needing independent judgment. Fully competent in own area of expertise. May have project lead role and or supervise lower level personnel. BS or MS degree or equivalent experienc...

Conduct preliminary review of: Batch Documentation Certificates of Analysis (CoAs) Change controls, deviations, and investigations Support preparation, review, and maintenance of: Specifications Test methods Master Manufacturing and Packaging Records Product artworks and labeling components Coordinate with contract manufacturing organizations (CMOs) for resolution of documentation queries and ensure timely turnaround. Assist in documentation for supplier qualification and product transfers. Maintain and update product master data in SAP, including: Material codes Specifications and test parameters Change control linkages Artwork version control Track and report progress on key quality action...

Set up and operate blister packing machines, Load materials, Monitor line performance & adjust settings as needed. Inspect packs, complete logs, checklists, and deviation reports.

Job Description Preparation & Review of SOP’s of QA system and review / approval of SOP’s of other departments. Review of master BMR/BPR of commercial and exhibit batches. Review of BMR / BPR, scale-up and placebo batches. Review of executed BMR/BPR of commercial and exhibit batches for batch release. Issuance, Retrieval & Destruction of SOP’s, STP, specification, BMR/BPR, annexures & other formats. Login and review of quality system documents such as Deviation and IPOOS. In-process Quality Assurance during Production / Packing activities. Sampling at different stages of manufacturing / packing as per the requirement (In-process, BU, CU, finished, control, QP, Hold Time & stability etc.) Rev...

Design, develop, troubleshoot and debug software programs for databases, applications, tools, networks etc. Responsibilities As a member of the software engineering division, you will take an active role in the definition and evolution of standard practices and procedures. Define specifications for significant new projects and specify, design and develop software according to those specifications. You will perform professional software development tasks associated with the developing, designing and debugging of software applications or operating systems.