1740 Change Control Jobs

QA Documentation Validation / Qualification Documents Control and Archival of documents Retain Sample Handling and Observation SOP Preparation and Revision related Activities BMR Preparation and Review Monitoring of all the QA activities, test results, leaked defects, and identifying areas of improvement. Handling of QMS Related Activities (change control, deviation, Market Complaint, incident, OOS). Knowledge of regulatory guidelines and requirements, such as FDA, MHRA, and ICH & ISO Standard.

To check documents like equipment log books, temperature & humidity records, Collect in-process and Finished sample as per Specifications and Protocol. Supervision of RM/PM Sampling and dispensing procedure. Machine Line clearance of Production Area. Area Line Clearance of Production area Checking online tablet weight variation, hardness, friability, thickness & DT Time & check informality of weight. Verification of granulation, Compression, Coating, & Packing process & also release for same. Able to fill And Check BMR. Able to Give Batch Approval, verify various Documents. Able to finalize Quality of Finished goods. DOCUMENTATION

PRODUCTION PLANNING & EXECUTION MANPOWER MANAGEMENT QMS KNOWLEDGE 4M,KAIZEN,14Q,QCC OEE MONITORING Risks & Risk mitigation plan in the manufacturing process to achieve smooth material flow

5+yrs experience in Production planning in process industry. He/She must be responsible for understanding an organization's business requirements, sorting out the business user's day-to-day queries. Must take part in ACCB (Change Control) to approve/disapprove the change request. Also need to support into the S4 HANA transformation discussion.

IMMEDIATE JOINERS ONLY Job Title: SAP PP Consultant Location : Bengaluru/ Hyderabad (Hybrid) Job Description: 5+yrs experience in Production planning in process industry. He/ She must be responsible for understanding an organization's business requirements, sorting out the business user's day-to-day queries. Must take part in ACCB (Change Control) to approve/disapprove the change request. Also need to support into the S4 HANA transformation discussion. Role & responsibilities Preferred candidate profile

Role & responsibilities Quality Management System (QMS): Implement, maintain, and improve the Quality Management System in compliance with GMP and regulatory standards (e.g., USFDA, EMA, WHO). Review and manage QMS elements such as Deviations, CAPA, Change Controls, Out of Specification (OOS), and Document Control. Participate in internal and external audits; ensure timely closure of audit observations. Support quality risk management and periodic review activities. Validation & Qualification: Prepare and review validation documents including Validation Master Plan (VMP), protocols, and reports (IQ, OQ, PQ). Oversee qualification of equipment, instruments, utilities (HVAC, purified water, co...

Bachelor degree with a Minimum of 5 to 7 years in project coordination. Demonstrated experience in developing presentations, spreadsheets, and other supporting documents. Excellent organizational and analytical skills.

Manage day-to-day office operations, including administrative tasks and employee coordination. Handle communications, both internal and external, ensuring timely responses and follow-ups. Organize meetings, prepare agendas, and take minutes for effective documentation. Maintain office supplies and ensure all equipment is in working order. Assist with budgeting, invoicing, and other financial tasks as needed.

Experience: 2 to 5 years Education: Bachelor's degree in Biomedical, Mechanical, or B.Pharm We are looking for talented professionals for roles in Quality Assurance , Regulatory Affairs , and Documentation in the Medical Devices domain. Skills & Requirements: Minimum 3 years of experience in Medical Devices Regulatory Affairs , Quality Assurance , or Documentation Strong knowledge of global regulatory frameworks: FDA QSR, ISO 13485, EU MDR, IEC standards Experience in DHF assessment and remediation Familiarity with FDA 21 CFR Part 820.30 and ISO 13485:2016 design control requirements Documentation skills validation reports, change control, deviation records Strong communication skills, both ...

SUMMARY ASSOCIATE PRODUCTION - ASSEMBLY & SFT Requirements PLANNING AND EXECUTION MANPOWER MANAGEMENT OEE MONIOTORING QMS KNOWLEDGE KAIZEN,4M,14Q TROUBLE SHOOTING

Role : Clinical Research Project Manager Location : Chennai, Tamil Nadu Experience : 10-15 Years Requirements: 1012 years of direct, hands-on experience in clinical trials, with a focus on interventional studies (Phase IIV). Proven ability to read, interpret, and operationalize clinical trial protocols into eSource/EDC workflows. Experience managing end-to-end clinical trial processes including start-up, site initiation, data collection, query management, and close-out. Minimum 45 years of people management experience with demonstrated success mentoring and leading CDM/clinical trial teams. Strong expertise in clinical trial systems CTMS (CRIO preferred), eSource, and EDC platforms. Backgrou...

Role & responsibilities To follow and adhere to Company Policy. Monitoring of all warehouse activities at Vizag Sites (Unit-1, 3, 4, 5, 6&LSPL). Monitoring of all Commercial Department activities at Unit-1, 2, 3,4,5,6 & LSPL. Liaising with Govt.Authorities like Excise, Customs, Narcotics & Explosive Departments. Co-ordination with QA Department during the Internal, Customer and Regulatory Audits. Responsible for Audit Compliance and cGMP implementation in warehouse. Review of Warehouse SOPs and related documents. Lead the investigation of failures pertaining to raw materials. Ensure to initiation of deviations, change controls, CAPA for Quality System implementation is inline with the cGMP. ...

Role & responsibilities Implement and maintain the Quality Management System (QMS) Ensure compliance with regulatory requirements (cGMP, ICH, etc.) Conduct internal audits and review quality documentation Oversee quality control activities, including data review and release Investigate quality deviations and implement corrective actions Support regulatory inspections and submissions Lead and mentor a team of QA professionals Drive continuous improvement initiatives Preferred candidate profile Advanced degree in Pharmacy, Chemistry, or related field 5+ years of experience in API manufacturing QA/QC Strong understanding of cGMP, ICH guidelines, and regulatory requirements Excellent leadership,...

shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc Label artwork review and management Required Candidate profile Assisting HOD in customer complaint analysis and preparation of customer complaint report. Investigation of incidents, deviations, OOS and ensure corrective actions in place.

Hiring 'Manager - Quality Control' for a leading MedTech company. Position: Manager - Quality Control Location: Bangalore Req. Experience: 6~10 years into quality control Role & Responsibilities:- Lead and manage the Quality team to ensure product and process compliance. Oversee inspections, audits, CAPA, and supplier quality. Support regulatory requirements and drive continuous improvement. Lead, train and mentor quality team members. Overseeing incoming, and final inspection activities. Establish and track KPIs for Quality Team members Assigning the Daily Incoming Quality Control and Final Quality Check tasks and managing them. Represent the quality function at management reviews and strat...

Pangea Global Services is looking for Database Researcher to join our dynamic team and embark on a rewarding career journey. Collect, verify, and organize large datasets for research and analytics purposes. Design and manage databases ensuring data integrity, security, and accessibility. Develop automated tools for data extraction and cleansing. Collaborate with analysts to support data - driven decision - making and research insights. Disclaimer : This job description has been sourced from a public domain and may have been modified by Naukri. com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before app...

Role & responsibilities :- Handling of Deviations, OOS (Out of Specification), and OOT (Out of Trend): Investigation Execution and Reporting: Impact Assessment: Quality Risk Assessment: Perform risk assessments. Document risk levels and mitigation strategies to support decision-making and continuous improvement. Knowledge of Investigation Methodologies: Apply systematic approaches to identify root causes and contributing factors. Recommend effective CAPA based on investigation findings. Maintain awareness of current regulatory expectations (e.g., FDA, EMA, WHO) regarding investigations and data integrity.

Preparation, review and approval of stability summary report. Preparation, review of freeze thaw study protocol and report Preparation, review of temperature cycle study protocol and report. Required Candidate profile To review AMV, STP, specification, worksheet of finished and raw material packaging material & To Review and implement Validation protocol for process, equipment, cleaning and Analytical Validation.

Scope of the role: 1. Prepare document templates for design documents as per customer needs 2. Review design documents prepared by design team, update and make ready for submission to customer 3. Prepare user documentation like technical manual, operational manual, maintenance & trouble shooting manuals 4. Focus on aerospace, but in future need to learn other domains like defence, space, automotive, healthcare Required skills / experiences: 1. Handled storage of design documents – Word/Excel/ppt and ECAD, MCAD, Analysis/Simulation files – in Configuration and change control systems or PLMS for at least 3 years in a PRODUCT BASED company 2. Handled Base line creation and Version management of...

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Role Overview: As a Quality Assurance Specialist at this organization ranked among the top 500 global companies, you will play a crucial role in monitoring the overall Quality System status of the distribution center. Your compliance to drug, medical device, and local regulations will ensure the maintenance of quality processes through procedures, training, and inspections. Key Responsibilities: - Ensure all staff is trained in their job functions, including GMP standards. - Write and revise Standard Operating Procedures as necessary. - Conduct regular facility inspections, maintain records, summarize findings, and report them accordingly. - Coordinate or assist in corrective actions and pre...

As a Manager, R&D Process Quality at Amgen, you will play a crucial role in implementing Amgen's Process Quality strategy to ensure compliance with all applicable regulations and quality requirements. Here's what you can expect in this role: **Role Overview:** You will work with a team dedicated to maintaining Amgen's Research and Development Standards by ensuring clear and effective procedures for all research tasks. Your contribution will support the Quality Management System (QMS) and drive continuous improvement in Amgen's R&D processes. **Key Responsibilities:** - Support Amgen's procedural framework to ensure compliance with laws, regulations, and internal quality standards while uphol...

Role Overview: As a Senior Executive in the Quality Assurance department at ZLL-SEZ Oncology Injectable (Alidac), your role is critical and involves responsibilities such as reviewing and authorizing testing work sheets for various materials, ensuring compliance with Good Laboratory Practices, handling stability samples, reviewing analytical data, initiating change controls and investigations, participating in regulatory audits, and ensuring calibration and maintenance of equipment. Key Responsibilities: - Review and authorize testing work sheets for Raw Material, Packaging Material, In-process, Finished product, and stability studies - Ensure compliance with Good Laboratory Practices and re...

You will be responsible for various quality assurance activities in the food industry. Your key responsibilities will include: - Handling Change Control, Deviation, Out of Specification, Market Complaint, Corrective and Preventive Action (CAPA), and Annual Product Quality Review. - Preparing Audit Compliance Reports and ensuring label compliance as per Legal Metrology and FSSAIs Labelling and Display Regulations. - Implementing GMP/GHP requirements in the food industry. In terms of Qualification / Calibration / Validation, you will be in charge of: - Conducting all Calibration activities internally and externally and maintaining records. - Ensuring Equipment Qualification and Documentation c...

As a Supervisor in the Sterile manufacturing department, your role involves preparing, reviewing, revising, controlling, and implementing standard operating procedures related to activities such as Change control and CAPA. You will be responsible for ensuring the smooth functioning of the department. Your key responsibilities will include: - Preparation, review, revision, control, and implementation of standard operating procedures for the Sterile manufacturing department - Document preparation for activities like CCF, SOP, Investigation, Risk Assessment, Protocol, etc. Qualifications required for this role: - M.Sc in Pharmacy or M.Pharm - Minimum 8 to 11 years of relevant experience in the ...