1740 Change Control Jobs - Page 20

Skill: CSV Manager Notice Period: Immediate . Employment Type: Contract Working Mode : Hybrid Job Description 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

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...

Job Title: QA Executive Quality Systems Department: Quality Assurance Location: Vadodara, Gujarat Key Responsibilities: 1. Quality Management System (QMS): Maintain and update the QMS in compliance with GMP and regulatory standards. Ensure documentation practices align with GDP (Good Documentation Practices). Support implementation and continuous improvement of QMS processes. 2. Change Control: Review and assess change control requests related to equipment, processes, and documentation. Conduct risk assessments and impact analysis for proposed changes. Ensure timely closure of change controls with proper documentation and approvals. 3. SOP Management: Draft, review, and revise Standard Opera...

Responsibilities: Ensure compliance with QMS protocols in production and packing areas. Review and maintain batch records, SOPs, and documentation as per USFDA standards. Support deviation investigations, CAPA, and change control processes. Coordinate with cross-functional teams to uphold GMP and regulatory requirements. Key Skills: Knowledge of QMS and GMP in pharmaceutical manufacturing. Experience in USFDA-audited facilities preferred. Strong documentation and communication skills. Proffered Candidate Profile: Bachelors or Masters degree in Pharmacy or related field. 2–4 years of experience in pharmaceutical production or packing, preferably in a USFDA-audited facility. Strong understandi...

As a Regulatory Submission Specialist, your role involves handling the regulatory submission of new products, variations, and responses to queries for the US and OAM regions. Your primary responsibility is to prepare quality dossiers to ensure timely approvals for life cycle management. Key Responsibilities: - Review and prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review various documents such as Development reports, scale-up reports, specifications, stability protocols, and analytical validations before initiating Exhibit batches. - Prepare responses to deficiencies to facilitate the approval of products filed with regulatory agencies. - Manage the ...

As a Vendor Quality Assurance Specialist, your role is crucial in ensuring that all vendors supplying materials meet the company's quality standards and regulatory requirements through a structured vendor qualification and evaluation process. Key Responsibilities: - Initiate and coordinate vendor qualification activities for both new and existing vendors. - Prepare and maintain vendor qualification dossiers and files to ensure documentation accuracy. - Coordinate with procurement and other departments to gather necessary vendor data and documentation efficiently. - Ensure vendors comply with Good Manufacturing Practices (GMP), regulatory requirements, and company quality standards to uphold ...

As a Tidal Admin/Scheduler, you will play a crucial role in managing Tidal Admin and Scheduling with 5-7 years of experience. Your responsibilities will include: **Tidal Admin:** - Experience/Understanding of Hosting Tidal on AWS Cloud - Expertise in AWS Cloud (EC2, RDS, Load balancers, NFS, Security groups. Subnets, Networking) - Experience in Installing the Tidal Master on Unix - Experience in Installing the Tidal Client Manger on Unix - Experience in installing Tidal Agents on Unix and Windows - Troubleshooting the Master/Client Manager/Agents - Handling the P1/P2 priority calls - Experience/Understand of running the SQL Queries - Experience in using SSL for Client Manager - Experience in...

As a Project Director at Gleeds, your role will involve providing strategic advice at the project conception stage, leading the entire project to achieve success criteria, and managing quality, safety, health, and environment issues. Your responsibilities will include: - Advising on different approaches for achieving client objectives - Planning and managing project quality, safety, health, and environment aspects - Establishing effective project governance and processes - Developing and delivering detailed project plans - Leading and facilitating cross-functional project teams - Monitoring performance using KPIs and improving project performance - Managing change control processes - Advisin...

Role Overview: As a Senior Executive at Dishman Carbogen Amcis Limited in Bavla, Gujarat, you will be responsible for preparing DMF / ASMF / CEP dossiers following ICH M4 CTD/eCTD guidelines. You will also handle responses to queries from regulatory agencies and customers, prepare Applicants Part of ASMF based on customer requirements, and manage renewals and revisions for CEPs / annual reports for USDMFs / ASMF variations. Additionally, you will stay updated on global regulatory requirements, evaluate change control applications for regulatory implications, and provide regulatory input for analytical method validation reports and stability protocols. Key Responsibilities: - Prepare DMF / AS...

As a Manager - Quality at Dishman Carbogen Amcis Limited, located in Bavla, Gujarat, your role will involve the following responsibilities: - Handling of Change control - Handling of Deviation and CAPA management system - Handling of Internal and external audits - Sound knowledge about Equipment and Utility qualification - Should have thorough understanding about regulatory guidelines, cGMP norms, GLP, GDP, Data integrity requirements etc. - Should have experience of regulatory audits The company, Dishman Carbogen Amcis Limited, operates in the General business unit and is committed to maintaining high quality standards in accordance with regulatory requirements.,

As a Document Controller at Ferring India Laboratories, your role involves handling the issuance, control, and retrieval of documents. You will be responsible for scanning and uploading approved paper-based documents in Veeva Vault. Additionally, maintaining master copies for SOPs, including issuance, control, and retrieval of SOPs will be a key part of your responsibilities. Your key responsibilities will include: - Managing and conducting training sessions - Organizing training programs - Maintaining vendor audit and technical agreement planners - Preparing and reviewing SOPs, Protocols, and other cGMP documents - Tracking Change control, CAPA, Deviation, OOS/OOT, and coordinating with sta...

As an Associate Manager in the Quality Control Department at ZLL-SEZ Oncology Injectable (Alidac), your role is critical and involves the following key responsibilities: - Plan routine activities of the respective section. - Review all analytical raw data and associated documents for accuracy, including calibration/qualification reports, trend data analysis, and quality control testing protocols. - Report and follow up on any discrepancies noticed during the review process, including deviations and incidents. Perform predictive stability analysis on generated data for stability studies. - Log change controls and ensure proper execution following SOPs. Evaluate proposed changes for impact on ...

As a Site Quality Head at our reputed pharmaceutical manufacturing company in Vapi, Gujarat, you will be responsible for leading and overseeing the Quality Assurance and Quality Control functions at our Oral Solid Dosage (OSD) facility. Your role will involve full ownership of quality systems, lab operations, regulatory compliance, and audit readiness. To excel in this position, you should currently hold a site-level quality head role and have hands-on experience managing QA and QC teams in a regulated pharmaceutical environment. **Key Responsibilities:** - Lead and manage the complete Quality function (QA and QC) at the site - Ensure compliance with GMP, regulatory, and customer requirement...

As a Production and Manufacturing Specialist, you will play a crucial role in ensuring the smooth functioning of production activities. Your key responsibilities will include: - Preparing work instructions for Production and manufacturing activities. - Carrying out production activities as per the production plan. - Monitoring the batch process to maintain efficiency. - Maintaining online documentation related to production activities like BMR, BPRs, logbooks, and daily records. - Qualification of production equipment and active participation in validation activities. - Taking line clearance at various stages for a streamlined process. - Issuing requisitions to the store department for Raw m...

Handle quality complaints, aberrations & compliance, Perform RA, RCA, CAPA, Review &approve deviation, batch record, change control, CAPA, SOP, QMS documents, test method, sampling, Vendor Mgt, dispatch, Approve & review validation/qualficn protocols Required Candidate profile M.Sc.(Chem/Pharma) with 4 to 8 yrs exp in API industry. Knowledge of quality systems, legal documentation & Compliance, instrument handling & calibration, Instruments , Root Cause Analysis Techniques

Title: Manager - Quality Custom Field 2: 2490 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: Handling of Change control, Handling of Deviation and CAPA management system, Handling of Internal and external audits, Sound knowledge about Equipment and Utilty qualifcation, Should have thorough understanding about regulatory guidelines, cGMP norms, GLP, GDP, Data integrity requirements etc. Should have experience of regulatory audits. Job Segment: Quality Manager, Law, CAPA, Manager, Quality, Legal, Management

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team. The ideal candidate will have expertise in ServiceNow and HPALM. Roles and Responsibility Manage and implement CSV solutions using ServiceNow and HPALM. Collaborate with cross-functional teams to ensure seamless integration of CSV with other systems. Develop and maintain documentation for CSV processes and procedures. Troubleshoot and resolve issues related to CSV implementation. Provide training and support to end-users on CSV tools and features. Ensure compliance with industry standards and best practices for CSV management. Job Requirements Strong knowledge of ServiceNow and HPALM. Experience in managin...

We are looking for a skilled SAP CRM-C4C professional with 9 to 20 years of experience. The ideal candidate will have expertise in SAP C4C and be able to work effectively in a fast-paced environment. Roles and Responsibility Manage and implement SAP C4C solutions for clients. Collaborate with cross-functional teams to identify business requirements and develop solutions. Provide training and support to end-users on SAP C4C functionality. Troubleshoot and resolve technical issues related to SAP C4C. Develop and maintain documentation of SAP C4C configurations and customizations. Ensure data integrity and security in SAP C4C implementations. Job Requirements Strong knowledge of SAP C4C modules...

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

Requisition for Executive for the implementation and monitoring of GLP in TIC. Skills Required : Good Laboratory Practice, Quality Assurance, MS Office Package, Communication Skills Roles and Responsibilities : Preparation of documents related to applying GLP (Good Laboratory Practices). Ensure the upkeep and maintenance of the laboratory by implementing GLP. Ensure compliance with GLP standards. Logbook management, sample management, SOP management, and other document management related to GLP. Any other work related to Quality assurance assigned by the manager. GLP-trained person or experience working in GLP labs. Must have good verbal and written skills.

Guhring India Pvt Ltd is looking for Engineer - Quality Control to join our dynamic team and embark on a rewarding career journey Analyzing customer needs to determine appropriate solutions for complex technical issues Creating technical diagrams, flowcharts, formulas, and other written documentation to support projects Providing guidance to junior engineers on projects within their areas of expertise Conducting research on new technologies and products in order to recommend improvements to current processes Developing designs for new products or systems based on customer specifications Researching existing technologies to determine how they could be applied in new ways to solve problems Rev...

JOB PURPOSE : On boarding new customers, disbursement & collection of dues in villages PRINCIPAL ACCOUNTABILITIES Starting business in a new village a. Village identification within the radius b. Feasibility study of the village based on demographics, activities and financial needs of the customers c. Assist the MC-IC in making the village approval Sourcing of business a. Identification of customers and forming of Joint Liability Groups b. Filling up of the application form c. Verification of the residence and business of the customer d. KYC verification e. Pre-disbursement training f. Visiting potential customers in order to develop business Disbursements a. Collection of KYC documents b. A...

JOB PURPOSE : On boarding new customers, disbursement & collection of dues in villages PRINCIPAL ACCOUNTABILITIES Starting business in a new village a. Village identification within the radius b. Feasibility study of the village based on demographics, activities and financial needs of the customers c. Assist the MC-IC in making the village approval Sourcing of business a. Identification of customers and forming of Joint Liability Groups b. Filling up of the application form c. Verification of the residence and business of the customer d. KYC verification e. Pre-disbursement training f. Visiting potential customers in order to develop business Disbursements a. Collection of KYC documents b. A...

JOB PURPOSE : On boarding new customers, disbursement & collection of dues in villages PRINCIPAL ACCOUNTABILITIES Starting business in a new village a. Village identification within the radius b. Feasibility study of the village based on demographics, activities and financial needs of the customers c. Assist the MC-IC in making the village approval Sourcing of business a. Identification of customers and forming of Joint Liability Groups b. Filling up of the application form c. Verification of the residence and business of the customer d. KYC verification e. Pre-disbursement training f. Visiting potential customers in order to develop business Disbursements a. Collection of KYC documents b. A...

JOB PURPOSE : On boarding new customers, disbursement & collection of dues in villages PRINCIPAL ACCOUNTABILITIES Starting business in a new village a. Village identification within the radius b. Feasibility study of the village based on demographics, activities and financial needs of the customers c. Assist the MC-IC in making the village approval Sourcing of business a. Identification of customers and forming of Joint Liability Groups b. Filling up of the application form c. Verification of the residence and business of the customer d. KYC verification e. Pre-disbursement training f. Visiting potential customers in order to develop business Disbursements a. Collection of KYC documents b. A...