74 Deviation Management Jobs - Page 2

Key Responsibilities Lead, manage, and develop the QC function for pharma formulations as per company policies and regulatory requirements. Supervise and resolve lab incidents, deviations, change controls, OOS/OOT , and ensure robust documentation and root cause analysis. Oversee process validation, cleaning validation, hold time studies and related compliance activities. Establish and implement Stability Study protocols as per company SOPs, client specification, and all applicable quality standards. Handle product complaints & recall investigations in collaboration with QA and Production teams. Ensure compliance with current GMP, GLP, and regulatory guidelines for all laboratory operations....

As a QA Manager at Systacare, a trusted name in the pharmaceutical industry, your primary responsibility will be to ensure adherence to regulatory requirements and maintain the highest standards of compliance in injectable manufacturing. With a strong focus on innovation, compliance, and patient safety, Systacare is expanding its team and is seeking passionate professionals to join the organization. You will lead and manage the QA team to ensure compliance with cGMP, regulatory standards, and company SOPs. Your role will involve overseeing quality systems, including deviation management, change control, CAPA, OOS, and OOT investigations. It will be crucial for you to ensure quality assurance...

As a Senior Manager 2 in the Global Quality CMO department at Sun Pharmaceutical Industries Ltd, your primary responsibility will be to ensure that SUN Pharma Quality and Compliance Standards, along with global regulatory authorities requirements, are consistently met across all SUN affiliates, CMOs, Suppliers, and SUN sites/Operational Units. Your role will involve providing Quality Oversight, conducting Independent auditing, and implementing necessary Follow-up actions to achieve, maintain, and enhance the desired level of compliance. Your essential job functions will include participating in the evaluation of Contract Manufacturing Organizations (CMOs), overseeing and approving various Qu...

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

Job Summary: Responsible for supporting business planning, cost management, and financial analysis for product lines. This role involves close coordination with Value Streams and support functions to drive cost efficiency, accurate forecasting, and business performance tracking. Key Responsibilities: Assist in finalizing Business Plans, Forecasts, and Monthly Reviews Analyze and control product-wise cost performance Validate cost-saving initiatives and track through mY-Measures Maintain and validate SAP costing and accounting data Provide cost estimates for sales and product teams Perform variance and deviation analysis with corrective action inputs Support investment evaluations using NPV, ...

As a Manager 1 at Sun Pharma Laboratories Ltd in Guwahati - Regulatory Affairs, your primary responsibilities will include: - Facilitating the harmonization and consistent implementation of Quality System and procedures at the site in alignment with Corporate Quality Policies/Procedures. - Reviewing documents related to Quality Management System (QMS) & Compliance. - Ensuring compliance of the Quality Management System. - Participating in Site Training Programs as per site and Global Quality Standards requirements. - Submitting Dossier documents after review against requests received from Corporate regulatory affairs. - Responding to queries related to submitted dossiers as per requests from...

As a Branch Officer at Sahayog Multistate Credit Co-operative Society, you will play a crucial role in ensuring the smooth operations of the branch while upholding high standards of accuracy, compliance, customer service, and achieving sales targets. Your primary responsibilities will include: - Maintaining 100% accuracy in cash handling and processing with a focus on quality and error management. - Managing timely cash requisition and ensuring high-quality transaction entries in the system. - Achieving 95% and above quality in account opening and loan processing, adhering to KYC compliance and proper documentation. - Ensuring zero deviations in critical audit points and timely reporting of ...

We are seeking a detail-oriented Deputy Manager Quality Assurance to support robust QA operations and also some Regulatory Affairs functions at Acharya Group's API manufacturing unit. This role focuses on maintaining our Quality Management System (QMS) for API production, ensuring cGMP and regulatory compliance for EU, USFDA, PMDA, and other Major Regulatory Regions. Key responsibilities include participating in batch release and continuous improvement; overseeing validation of API manufacturing processes, equipment, and analytical methods, managing deviations, conducting investigations, and implementing CAPA plans. Candidates must have prior experience in Quality Assurance within API manufa...

To be well worsed with analtical instruments like HPLC,GC,FTIR,UV,POTENTIOMETER ,POLARIMETER and their application softwares To be have good knowledge in trouble shooting of instruments Should be familiar with LIMS Documentation system Should be having the experience in review of documents and other systems Should have the QMS handling knowledge like , Lab incidents , Deviation , OOS ,OOT etc,,

You should possess a B. Pharmacy/M. Pharmacy (Pharmaceutical Analysis and Quality Assurance) or M. Sc. in Chemistry or equivalent with 5 to 8 years of experience in formulation pharmaceutical industries in the quality control department. In this role, you will be responsible for handling day-to-day activities related to sampling, testing, and release of active ingredients, inactive ingredients, packaging materials, in-process and finished products, stability samples. Your primary responsibilities include ensuring that all activities within the quality control section meet current applicable cGMP guidelines and regulatory expectations. You will be accountable for ensuring timely sampling, ana...

As a qualified candidate with a Master's degree in Chemistry and 3 to 8 years of relevant experience, you will be responsible for various key activities in the near Vadodara location. Your primary tasks will include managing deviations, implementing quality systems, ensuring regulatory compliance, conducting process validation, and handling documentations and audits effectively. This full-time, permanent position offers benefits such as Provident Fund along with a day shift schedule. The work location is on-site, requiring your presence for the successful execution of the mentioned responsibilities.,

The Full Stack Developer position at ClinRT Global Services in Pune requires a minimum of 2 years of experience in Angular and .NET core. ClinRT is committed to revolutionizing clinical trials through its Interactive Response Technology (IRT) platform, aimed at enhancing efficiency, accuracy, and compliance in drug development. As a trusted partner to pharmaceutical companies, researchers, and healthcare professionals, ClinRT streamlines patient interaction, randomization, drug supply management, and data management for a seamless clinical trial process. The Clinical QA Manager role involves overseeing the quality of activities related to the IRT platform used in clinical trials developed by...

Designation: Compliance Specialist Experience: 3 - 5 years Location: Remote (India) Job Responsibility: Assist with Quality System development, training, and process. Assist with internal audits to assess compliance. Represent or assist SI in external audits. Participate in the CAPA process. Roles & Responsibilities: Assist and work to create, review, and update Quality System procedures, assisting the Quality Management Leads and Director, Quality Management. Provide or manage Quality System training Managing all quality-related documents (procedures, specifications, records etc.) with version control and electronic approvals. Conduct RCA meetings for the CAPA process Assist with internal a...

As a Patient Safety Support Manager, your primary responsibility will be to manage the outcomes of various audits related to Pharmacovigilance (GVP) systems and processes. This includes overseeing internal audits, business partner audits, deviation investigations, and providing support for the PV Quality Management System (QMS). Your duties and responsibilities will involve ensuring that corrective and preventative actions are promptly authored and implemented following post-evaluation of GVP audits. You will collaborate effectively with external quality and compliance organizations to uphold high standards of quality within the department. In addition, you will participate in or lead assess...

Who We Are TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry&aposs broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, these enable TAPI to lead the industry, based on our experience, expertise, technologies, and exceptional customer service. Our employees are at the core of our success. Our Headquartered is in Israel, TAPI employs more than 4,000 professionals at 14 sites...

The Technical Writer Change Control Management is responsible for developing, managing, and maintaining documentation related to change control processes within a regulated manufacturing environment. This role ensures documentation accuracy, consistency, and compliance with regulatory and organizational standards. You will leverage your knowledge of science and manufacturing technologies to collaborate effectively with cross-functional teams, streamline documentation workflows, and support the organization's change control management processes. You will develop, revise, and maintain high-quality documentation related to change control processes, ensuring alignment with cGMP and other regulat...

You will be working as a Senior Executive in the Quality Assurance department at ZLL-SEZ Oncology Injectable (Alidac). Your primary responsibility will involve reviewing Raw Material, Packaging Material, In-process, Finished product, shelf life specification, and relevant Method of analysis. You will authorize the Testing worksheet and approve analytical data of various materials in LIMS. Additionally, you will ensure compliance with Good Laboratory Practices and review analytical method validations, transfers, and verifications. Your role will also include handling, storage, withdrawal, and reconciliation of stability samples, reviewing stability study reports, verifying outside laboratory ...

As a candidate for this role, you should have a good understanding of CSV and Business Process Automation. You will be expected to be knowledgeable about digital automation activities and be able to prepare documentation for digitalization systems according to defined procedures. Your responsibilities will include conducting supplier/service provider assessments for digitalization processes, creating standard operating procedures for the operation and maintenance of digitalization systems, and preparing impact assessments and risk assessment reports related to digitalization processes. You will be accountable for ensuring that supplier/vendor documents are in order for the digitalization sys...

As a candidate for this role, you should possess awareness of CSV (Computer System Validation) and Business Process Automation. Your familiarity with digital automation activities will be crucial in preparing documentation for the Digitalization System according to defined procedures. You will also be responsible for conducting Supplier/Service Provider Assessments for the Digitalization Process and creating Standard Operating Procedures for the operation and maintenance of the Digitalization System. In this role, you will be tasked with preparing Impact Assessments and Risk Assessment reports related to the Digitalization Process. It will be your responsibility to ensure that supplier/vendo...

As a Shift Leader at Continental Automotive Components Private Ltd., your primary responsibility will be to execute Shift Leader routines efficiently. You will also be required to perform LSW Routines and communicate any problems or deviations in routine fulfillment with the Production Manager or Head of Production Segment. In case of systematic failures, you are expected to identify them and initiate Problem-Solving measures promptly. You will play a crucial role in coordinating, supporting, and coaching the Line Leader to achieve the targets for internal production Key Performance Indicators (KPIs) such as PPM, Scrap Rate, OEE, Rejection Rate, and more. Deviation management is an essential...

Position : Executive Engineering QMS Qualification : BE Mechanical/ Electrical/ Instrumentation or B pharma preferably BE Experience : 6-7 years experience in handling engineering department GMP documentation activities and supporting engineering function as SME in QMS documentation Responsibilities : 1.Implementation of quality assurance standards, processes, controls and cGMP in warehouse. 2. Preparation of SOPs and ensure effective implementation. 3. should be well versed with deviation management SOP 4. Should be well versed with change control and CAPA management related to engineering department 5. Should be familiar with documentation like DQ, IQ, OQ and PQ. 6. To ensure that training...

JOB PROFILE OF SR. TECHNICAL OFFICER-QUALITY ASSURANCE MENDINE PHARMACEUTICALS PVT LTD Job Title / Designation- SENIOR TECHNICAL OFFICER - QA Qualifications- M.PHARM Experience- 5 to 10 years experience in QUALITY ASSURANCE Job Objective- The ideal candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with cGMP guidelines, conducting internal audits, reviewing batch records, and supporting regulatory inspections. This role demands strong documentation skills, a sound understanding of pharmaceutical quality standards, and the ability to work collaboratively across departments to uphold product integrity and safety throughout the manufacturing proc...

Ensure compliance with GMP & regulatory standards, oversee quality systems, audits & validations, manage QA team, review batch records, handle deviations/CAPA, support regulatory inspections, ensure product quality & safety across manufacturing.

As a Quality Control Reviewer at TAPI, you will play a crucial role in ensuring the quality and compliance of our pharmaceutical products. Your primary responsibilities will include reviewing various documents such as batch records, test results, deviations, and corrective actions to determine the disposition of batches. You will also be responsible for monitoring manufacturing and packaging processes, investigating any errors or deviations, and implementing corrective and preventive actions as necessary. Your role will involve collaborating with internal and external stakeholders to address quality and compliance issues, facilitate batch reviews, and ensure the timely shipment and receipt o...