94 Change Controls Jobs - Page 2

As a dedicated and detail-oriented Quality Management System (QMS) Executive, your role will involve supporting and enhancing the organization's quality framework. You will be responsible for implementing, maintaining, and continuously improving the QMS in accordance with ISO 9001:2015 and relevant regulatory standards. Your main focus will be ensuring quality compliance across departments and fostering a culture of continuous improvement. Key Responsibilities: - Implement and maintain the Quality Management System in alignment with ISO 9001:2015 standards. - Develop, review, and control quality documents such as SOPs, manuals, work instructions, and records. - Plan and conduct internal audi...

Job Responsibilities To ensure the daily operations of analytical lab in ARD Department. Responsibility to analytical method development, validation, and routine testing. Manage release and stability testing of raw materials, in-process, and finished products on time. Preparation of validation protocols and reports as per USFDA, EMA and ICH guidelines. Ensure the lab instrument calibrations and maintenance as per the in-house protocol. Responsible for implementation of GLP activities in ARD lab. Responsibility to verify the all log books on daily basics. Preparation standard operating procedures in ARD Lab. Responsibility to ensure the sample management system in ARD Lab. Responsibility to e...

Review of all quality systems i.e Change controls, Deviations, Market complaints, OOT, OOS, CAPA etc., To monitor Batch manufacturing at CMOs and review and compliance of the documents as per the requirements. To conduct/participate internal quality audits & regulatory / customer audits. Communications with External Vendors/customers for relevant information/documents Co-ordination with cross-functional teams for meeting schedule timelines for commercial and development activities. Review of development and commercial batch documents

As an Authoring / writing and reviewing expert, your key responsibilities will include: - Authoring / writing and reviewing CMC sections of dossier - Critically reviewing design stage documents (specifications, controls, and protocols) to ensure regulatory requirements are met - Assessing change controls to determine regulatory impact and strategizing post-approval submissions - Coordinating the collection of post-execution data from various functions and reviewing for compliance with design specifications, controls, and protocols - Collaborating with cross-functional team members to ensure timely resolution of action items identified for responding to deficiencies - Reviewing and ensuring t...

About Birlasoft Birlasoft, a powerhouse where domain expertise, enterprise solutions, and digital technologies converge to redefine business processes. We take pride in our consultative and design thinking approach, driving societal progress by enabling our customers to run businesses with unmatched efficiency and innovation. As part of the CK Birla Group, a multibillion-dollar enterprise, we boast a 12,500+ professional team committed to upholding the Group's 162-year legacy. Our core values prioritize Diversity, Equity, and Inclusion (DEI) initiatives, along with Corporate Sustainable Responsibility (CSR) activities, demonstrating our dedication to building inclusive and sustainable commun...

Responsible for Overall site QA compliance activities and drive the organization towards quality improvements Handling of Deviation, Change controls, OOS, OOT and CAPA including investigations and impact assessments

In this role as a Quality Assurance professional, you will be responsible for the review and approval of Supplier Qualification documents, such as NSQR, VQ Documents, etc., from Raw material / Packing material manufacturers and external service providers. Your key responsibilities will include: - Preparing and distributing corporate approved supplier lists, New product tentative approved supplier lists, and Tentative approved supplier lists to all SQAs. - Providing support to site QA for regulatory audits and Customer audits. - Reviewing vendor notifications and coordinating with RA & SCM for further requirements. - Reviewing delist declarations from SCM and coordinating with RA & Site QA te...

As a SAP GRC & Security LEAD at Birlasoft, you will play a crucial role in ensuring the security and compliance of SAP systems. With your expertise in Security and GRC, you will be responsible for enforcing security controls, coordinating with internal audit teams, and mitigating SOD violations. Your attention to detail and process-oriented approach will enable you to build change controls and understand and meet customer requirements effectively. Key Responsibilities: - Work as a SAP Security & GRC Consultant with a minimum of 8-10 years of experience - Hands-on experience in Security and GRC - Enforce security controls using GRC - Coordinate with the internal audit team to set up controls ...

Stipend & Facilities offered for interns: B Pharm/ M Pharm - Stipend 12,300 Per Month Facilities - 1. Free cab (Pick up and drop) No 100% Confirmation on cab will be given. Only if there is a vacancy in the cab for your location, cab will be provided. 2. Free lunch 3. 1 paid leave per month Tenure: 6 Months to 8 Months Full Time General Shift Timings: 8:15 AM to 5:15 PM (candidates must be available for A & B shifts based on business needs) Working Days: 6 Days in a week Monday to Saturday (Rotational Shift) Please find the below JD for reference. Job Title: Intern NAPS Apprenticeship Gender preference: Male Location: Electronic City, Bengaluru Company: Biocon Biologics Limited Qualification...

As a Regulatory Affairs Manager at Ferring India Laboratories, you will be responsible for the following key responsibilities: - Prepare, compile, and submit regulatory dossiers and submission data. - Manage Test and Manufacturing License applications with state and central drug authorities. - Handle regulatory submissions, variation filings, technical report writing, and query responses. - Ensure compliance with Drugs & Cosmetics Act, New Drug & Clinical Trial (CT) Rules, and GMP guidelines. - Ensure adherence to national and international regulatory requirements. - Review product labeling and artworks for regulatory compliance. - Liaise with state and central regulatory bodies (e.g., CDSCO...

As an Associate II in Complex Gx, Regulatory Affairs at Teva Pharmaceuticals, you will be responsible for the preparation and submission of high-quality regulatory filings for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products. Your role will involve managing regulatory submissions, collaborating with cross-functional teams, evaluating change controls, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs. Additionally, you may serve as a regulatory point of contact for assigned products and contribute to process improvement initiatives. Key Responsibilities: - Prepare, review, and compile new submis...

As a Regulatory Affairs professional in our company, you will play a crucial role in ensuring compliance with regulatory guidelines and maintaining the highest quality standards in the technical documentation for regulatory filings. Your responsibilities will include: - Conducting CMC review of technical documentation for regulatory filings to various markets, with a focus on the US market - Performing Gap Analysis and Remediation for module 3 -CMC - Developing and implementing regulatory strategies, processes, and timelines for grant of MA in regions like Africas, GCC, LATAM, ASEAN - Reviewing CTD dossiers, variations, change controls, renewals to ensure compliance with regulatory guideline...

As an Infrastructure Engineer at our global healthcare biopharma company, you will be responsible for designing, implementing, managing, and supporting the infrastructure that enables the organization's IT systems and services to run smoothly. You will work with hardware, networking, virtualization, cloud environments, and security systems to ensure efficient, reliable, and scalable IT infrastructure. Your role will involve collaborating closely with software engineers, IT support teams, and system administrators to optimize performance, mitigate risks, and deliver high-quality services to end-users. Key Responsibilities: - Manage the design, procurement, installation, upgrading, operation, ...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary The position entitles the incumbent to possess adequate practical and technica...

Job Description Senior Manager, Senior DevOps Linux Engineer The Opportunity Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the...

As a Robotics Automation Specialist with 3-5 years of experience, your role will involve handling robotics arms and specializing in the automation process. You should have prior work experience in medical device manufacturing (such as implants, bone plates, titanium, plastic manufacturing) or the automobile industry with a focus on a robotic/automation division. Your proficiency should include working knowledge of Sensors, Vision Cameras, Conveyors, PLCs, Digital Systems, and Processes. Your responsibilities will include an in-depth understanding of Electrical & Electronic Systems, with the ability to comprehend new electronic devices and systems. You will be responsible for planning and exe...

Job Title: Sr. Executive / Assistant Manager Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from a reputed university Experience 8 to 10 years of similar experience in a regulatory-approved OSD manufacturing large unit. Job Responsibilities & Accountabilities We are looking for an experienced QA professional to join our team and lead Deviation & Complaint Investigations, along with core QMS activities. Key Responsibilities Lead deviation and market complaint investigations, with timely CAPA execution Ensure effective implementation and tracking of CAPAs from deviations & complaints Review Batch Manufacturing & Packing Records, APQR, and SOPs Manage Change Controls, V...

As a Research Scientist at Syngene International Ltd., you will play a crucial role in ensuring safety, compliance, and quality in all work activities within your responsibility area. Your primary responsibilities will include: - Ensuring safety and compliance in all work activities, adhering to Environment, Occupational Health, Safety, and Sustainability (EHSS) practices. - Monitoring and confirming adherence to quality, integrity, and compliance standards by yourself and direct reports. - Completing assigned trainings on time and ensuring compliance with training procedures. - Attending mandatory trainings related to data integrity, health, and safety measures. - Participating in and suppo...

Role Overview: As an Associate Manager / Manager in API Regulatory Affairs - DMF Filing/ Compilation for the global market, your responsibilities will include: - Hands-on experience in Regulatory Affairs-API/DMF Filing/DMF Compilation/ Submission/ Customer Communication. - Compiling and submitting DMFs globally for small molecule APIs in eCTD format, ensuring compliance with ICH and region-specific regulatory guidelines (EU, US, Canada, Japan, Australia, Brazil, China, South Korea, etc.). - Demonstrating good knowledge of all regulatory guidelines and API Regulatory processes. - Compiling responses to queries from Regulatory Agencies & customers globally, meeting specified timelines for subm...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Life Sciences, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life. At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by au...

Role Overview: As a Senior Technician Quality Control at Beckman Coulter Bangalore Development Centre, you will be responsible for conducting routine analysis of raw materials, in-process, and finished goods under supervision. Your main task will be to ensure compliance with Quality control procedures and activities according to 21 CFR 820, ISO 13485, ISO 9001, MDSAP, and Beckman Coulter corporate Quality system requirements. Your duties will include: Key Responsibilities: - Conduct routine analysis of raw materials, in-process and finished goods under supervision and in accordance with Standard Operating Procedures (SOPs). Compile data for documentation of test procedures and prepare report...

Position title: ESO QA Specialist University degree in Pharmacy, Chemistry, Biology, or relevant Life Science Minimum of 5 years in a similar role or equivalent experience in a GMP-related environment Job location - Ankleshwar, Gujarat, India MISSION STATEMENT To ensure the quality lifecycle management for dedicated, subcontracted, product portfolio. Qualified auditor. Main Accountabilities And Duties Operational skills Operational quality management of a dedicated product portfolio which includes: Quality management of deviation and complaint records and their related CAPAs Assessment and management of change controls Edition of QA Agreements with Zentiva third parties and subcontractors Co...

Introduction: Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S. Bhartia and Mr. Hari S. Bhartia with strong presence in diverse sectors like Pharmaceuticals, Life Science Ingredients, Contract Research & Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America. Jubilant Pharmova Limited Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research D...

Altera, a member of the N. Harris Computer Corporation family, delivers health IT solutions that support caregivers around the world. These include the Sunrise, Paragon, Altera TouchWorks, Altera Opal, STAR, HealthQuest and dbMotion solutions. At the intersection of technology and the human experience, Altera Digital Health is driving a new era of healthcare, in which innovation and expertise can elevate care delivery and inspire healthier communities across the globe. A new age in healthcare technology has just begun. Mandatory skills: - 5 to 10 Years of Working Experience Minimum 5 Years of working experience in Windows and Linux Systems. Recommended Certification: RHCSA/RHCE , Azure ,Micr...

As an experienced Engineer in the Biopharma industry, your role will involve the following responsibilities: - Reviewing engineering activities such as calibration, PM, breakdown maintenance, and utility operation to ensure compliance with written procedures for equipment and building infrastructure. - Participating in routine equipment breakdown workorder review meetings, assessing workorder reports for quality, and ensuring timely closure of workorders. - Supporting the annual review of equipment breakdowns and participating in remediation programs. - Reviewing calibration certificates of instruments and participating in calibration activities on the shopfloor. - Reviewing engineering desi...