1753 Change Control Jobs - Page 18

Title: Manager - API Custom Field 2: 2779 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: Preparation and review of Standard Operating Procedures. Issuance, review of OOS,OOT,Deviation,CAPA,Change Control & its Management. Handling and monitoring of control samples. To impart internal trainings to DCAL Employees. Review of Calibration records, Instrument Logs of Quality Control. To Review of Analytical Method Validation protocols and reports. Review of the Instrument qualifications and re-qualifications protocols of Quality control. Preparation & review of quality risk assessment docume...

As a Manager 1 at Sun Pharma Laboratories Ltd in Guwahati - Regulatory Affairs, your role involves facilitating the harmonization and consistent implementation of Quality System and procedures at the site in alignment with Corporate Quality Policies/Procedures. Your responsibilities include: - Reviewing documents related to Quality Management System (QMS) & Compliance - Ensuring compliance of Quality Management System - Attending Site Training Program as per site training program and Global Quality Standards requirements - Submitting dossier documents after review against requests received from Corporate regulatory affairs - Responding to queries for submitted dossier against requests receiv...

Responsibilities: Conduct HPLC, GC, UV, water analyses per BMRR. Implement change controls, manage deviations. Perform API manufacturing, intermediate handling, SRP processing.

Date: 30 Sept 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Manufacturing Services Lead and/or participate in regular facility walkthroughs for Biopharmaceutical Operations to adherence to all time audit readiness and compliance with regulatory requirements including Data Integrity assessment. Specimen Signature entry Verified by (Department Training Coordinator) (To be filled manually) Job Description explained by (Reporting Manager/Designee) (To be filled Job Description accepted by (Employee) (To be filled manually) Lead and/or participate in timely reporting of deviations, appropriate investigations to identify root cause or most probable root cause and proposal & implementati...

Ensure Site Quality control, investigation related to OOS, OOT deviations, laboratory incidents, customer complaints and CAPA.Sampling and analysis of Raw materials-APIs, intermediates, solvents and finished products of plant/commercial batches. Required Candidate profile Msc/MPharm), working in API Unit,aware of cGMP, USFDA regulations (21CFR),ICH-guidelines, process and cleaning validation protocols,online manufacturing compliance with regulatory requirements.

Job Title: Internal Audit Analyst Management Level: 11 Analyst Location: Bangalore Must have skills: Chartered Accountant with 2 - 3 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Good to have skills: Internal Audit experience with Big 4 or a global organization Job Summary : An agile, highly motivated, innovative thinker with a background in audit, risk, or compliance looking to join a fast-paced, global Internal Audit department that has embraced transformative capabilities including advanced analytics, dynamic risk assessment, and automation to retain its role as a trusted advisor to the business. You are looking to b...

Position: QA Executive Job Location: Nerul, Navi Mumbai Industry: Ayurvedic / Herbal Pharmaceuticals Qualification: B.Pharm /M. Pharm Designation & Salary: Commensurate with industry experience and expertise. Working Days And Time: 8:00 AM to 5 PM / 6 Days week / Sunday fixed Off. Key Responsibilities: Preparation and implementation of Standard Operating Procedures and Documentation like preparation of MFR, BMR, BPR, all types of Validation, Stability study protocols and reports. To implement and enforce cG.M.P. as per statutory requirements Giving feedback to management regarding discrepancies, deviations and any special matter. To attend external official work, seminars, meetings, discussi...

About the Job Were changing the way people think about customer service, and we need your help! Were looking for a Quality Assurance Team Lead to be responsible for recording, reviewing and evaluating production objectives and performance standards. Working with the Quality Team, this role involves ensuring we are in accordance with both our internal and client-partner metric goals, as well as identifying areas of opportunity, developing solution plans and coaching team members. As Quality Assurance Team Lead, You Will Manage administrative and reporting tasks associated with quality metrics Assist in providing actionable insights to our Operations Team and client-partners Partner with other...

Ruby Chemicals is looking for Specifications Manager to join our dynamic team and embark on a rewarding career journey. Define and maintain technical product specifications ensuring alignment with business and compliance needs. Collaborate with engineering and design teams to translate functional requirements into product specifications. Manage version control, validation, and documentation of specifications across product lines. Support audit readiness, standardization, and product improvement initiatives. 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 ...

QC planning; GLP/QMS; chemist schedule/qualification Plan/review validation, calibration -AMC/CMC; audits; SOP/STP prep/training; COAs; stability loading/protocols prep Compile batch analysis data Indent materials Internal/External Mail coordination Required Candidate profile QC lead(GMP pharma—oral solids). GLP/QMS docu; ICH method & process validation HPLC/GC/UV, dissolution stability; OOS & CAPA-change control; monthly SOP/STP prep/review-mentoring, working std dev,

QC planning; GLP/QMS; chemist schedule/qualification Plan/review validation, calibration -AMC/CMC; audits; SOP/STP prep/training; COAs; stability loading/protocols prep Compile batch analysis data Indent materials Internal/External Mail coordination Required Candidate profile QC lead(GMP pharma—oral solids). GLP/QMS docu; ICH method & process validation HPLC/GC/UV, dissolution stability; OOS & CAPA-change control; monthly SOP/STP prep/review-mentoring, working std dev,

What you will do Amgen is seeking a Sr Associate IS Business Systems Analyst to support and help lead the Change and Release Management processes within the ServiceNow platform. This junior-level process owner role is responsible for the documentation, enhancement, and day-to-day operational support of the change and release lifecycle, ensuring compliance with standard processes while seeking opportunities to streamline and automate. The ideal candidate will assist in managing the change and release process flow, help develop supporting workflows and approvals, track process metrics, and collaborate with stakeholders to drive efficiency and continuous improvement. This position offers an exc...

The primary responsibility of this role is to perform quality control reviews of of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures t...

The AIN Sr Associate QA plays a critical role in supporting disposition related tasks across the Amgen Quality Operations Network. The Senior Associate QA will leverage industry, technical, and quality systems knowledge to provide support of business performance and GMP disposition supporting processes across the network. The position will be responsible for tasks including the key responsibilities documented below and other disposition related job functions. This candidate will primarily work during regular working hours (9 am 6 PM local time) to enable the business in delivering Amgens mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen ...

Role Description: We seek a skilled Sr. Associate Validation Analyst to oversee and manage validation activities for AI platforms and solutions. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the AI products follow the required validation processes, documentation, and comply with Amgens standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: Plan, coordinate, and lead the execution of validation and change control activities, including qualification ...

What you will do In this vital role you will Support the R&D quality Audit and help to build quality into everything Amgen does. Data entry into Amgens Quality System of approved audit responses Audit resourcing/planning Quarterly Investigator Site audit planning including identifying audit resourc es t hrough risk assessment of audit targets on a regular basi s Yearly planning of other audit types including internal process/Service Provider and Affiliate Audits Updating Audi t tracking and accountability t ools and distrib uting/communicatin g all ocations to the audit teams Compiling Audit reporting metrics and communication Manage Audit documentation and filing Supporting outsourced audit...

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities

The AIN QA Technical Specialist plays a critical role in advancing Quality Assurance initiatives across the Quality Operations Network, with a particular focus on Management Review, Inspections and Compliance, and Technical Writing & Data Analytics. This role provides operational support, technical leadership, and cross-functional collaboration to ensure compliance, continuous improvement, and data-driven decision making in support of the Quality Management System (QMS). The position will be responsible for tasks including the key responsibilities documented below and other technical quality-related job functions. This candidate will primarily work during regular working hours (9 AM 6 PM loc...

Position Summary: The AIN Specialist QA plays a critical role in supporting product disposition related tasks across the Amgen Quality Operations Network. The Specialist QA will leverage industry, technical, and quality systems knowledge to provide support of product expiry management processes, product complaints processes, disposition manager training, and fulfillment of disposition related data requests across the network. The position will be responsible for tasks including the key responsibilities documented below and other disposition related job functions. This candidate will primarily work during regular working hours (9 am 6 PM local time) to enable the business in delivering Amgens...

The Senior Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require issue for further investigation. Evaluates and ensures triaged product complaint records align with applicable procedures Evaluates and owns complaint records with basic investigations Ensures quality of complaint records Completes assigned assessments per applicable procedures Applies analytical skills to evaluate sophisticated situations using multiple sources of information Implements the complaint process per SOP requirements Owns or manages the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guideli...

Role & responsibilities To review that all relevant quality management systems of Hosur manufacturing site are implemented and well maintained. To review, monitor and improve Quality performance of Hosur manufacturing site. To promote quality attitude, awareness, and mindset of the site by all proper means including training to the cross functional team members. Implement, audit, and develop quality management system, in line with Global quality policy/ manual and procedures relevant to area. Ensure the required process controls are in place wherever they are necessary. To review that testing and inspection of all raw materials, packaging materials and finished goods are carried out as per d...

What you will do In this vital role as Specialist Business Analyst as part of Operations Generative AI (GenAI) Product team to deliver cutting edge innovative GEN AI solutions across various Process Development functions(Drug Substance, Drug Product, Attribute Sciences & Combination Products) in Operations functions. As part of this role, you both engage with the business users and partners to elicit requirements and perform data analysis and metrics definition activities as part of a product team of key stake holders, data scientists, business analysts, and software engineers. Roles & responsibilities Collaborate with System Architects and Product Managers to manage business analysis activi...

Job Description Responsible for routine operations of power distribution system, D.G. Sets, HT Breakers, HT Yard, LT Breakers, switch gears and distribution panels. To Perform the preventive as per schedule and predictive maintenance as when required for all Electrical power distribution equipment's. To attend the breakdown maintenance of all Electrical power distribution equipment's like LT panels, D.G. Sets, HT Breakers, HT Yard, LT Breakers, and switch gears To attend the breakdown maintenance of Chillers, Air compressors, Boiler control system, Water system, cooling towers, and other utilities. To record daily log sheets related to Power distribution system SOPs and as instructed by supe...

We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, inclusive culture and talent experience and our ability to be compelling to our clients. You'll find an environment that inspires and empowers you to thrive both personally and professionally. There's no one like you and that's why there's nowhere like RSM. Role Profile for the Project Management Discipline The Project Management discipline spans Functional Roles that provide principles, methods, tools, and techniques for effectively...

At NiCE, we don't limit our challenges. We challenge our limits. Always. We're ambitious. We're game changers. And we play to win. We set the highest standards and execute beyond them. And if you're like us, we can offer you the ultimate career opportunity that will light a fire within you. So, what's the role all about A Program Manager is a key role in organizations, responsible for overseeing and managing multiple projects that are usually interconnected or align under a larger organizational goal. The role of a Program Manager involves planning, coordinating, and executing strategic initiatives that involve cross-functional teams and multiple stakeholders. How will you make an impact Exc...