53 Deviation Management Jobs - Page 2

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...

You will proactively assess quality issues and ensure compliance to QA/QC as per regulatory requirements in manufacturing operations and quality function at the site by keeping track of quality metrics. You will ensure the site is always ready for regulatory/statutory inspections/internal audits and regularly monitor the performance of each individual in the Quality department. You will facilitate internal and regulatory agency audits, ensuring findings from site audits are understood, assessed, and addressed comprehensively. Moreover, you will ensure the closure of audit observations by reviewing the CAPA and driving its implementation. Implementation of requisite changes at the plant level...

Schaeffler is a dynamic global technology company with a rich history of private ownership and entrepreneurial spirit. As a partner to major automobile manufacturers, aerospace, and industrial sectors, we offer numerous development opportunities. We are currently looking for a dedicated and detail-oriented Process and Customer Quality professional (QMPP) to join Schaeffler India Ltd (formerly Vitesco Technologies) at the Pune, Talegaon Plant. This role plays a crucial part in ensuring that our products meet internal specifications and customer expectations. The ideal candidate will spearhead continuous improvement efforts, manage quality systems, and collaborate with various departments to e...

We are seeking a highly motivated and detail-oriented Quality Management System (QMS) professional to join our Quality Assurance team at Mendine Pharmaceuticals Pvt Ltd. As a part of our team, you will play a crucial role in ensuring compliance with regulatory requirements and company standards by implementing and maintaining effective quality management systems. Your responsibilities will include managing various quality-related activities such as quality risk management, batch manufacturing record preparation, process validation, deviation management, and more. In your role, you will be expected to identify, assess, and mitigate quality risks associated with products and processes. You wil...

As a Lead QMS at Ai Health Highway, you will play a crucial role in implementing Quality Management System (QMS), ISO13485, EU MDR, and US FDA (510k) Risk Management processes for our cutting-edge medical devices. Your responsibilities will include creating device master records, updating technical documentation, and collaborating with internal and external stakeholders to establish a robust quality management and regulatory framework for our product pipeline. You will work closely with engineering and manufacturing teams to develop verification test strategies to ensure the safety and reliability of our products. Additionally, you will be involved in developing product requirements, support...

Line of Service Advisory Industry/Sector Not Applicable Specialism Risk Management Level Senior Manager Job Description & Summary At PwC, our people in audit and assurance focus on providing independent and objective assessments of financial statements, internal controls, and other assurable information enhancing the credibility and reliability of this information with a variety of stakeholders. They evaluate compliance with regulations including assessing governance and risk management processes and related controls. Those in internal audit at PwC help build, optimise and deliver end-to-end internal audit services to clients in all industries. This includes IA function setup and transformat...

The Quality Lead position at ProPharma involves driving positive change and process improvement in the assigned region. This role serves as an independent and objective entity, supporting various operational teams and performing quality activities as per ProPharma Group's Quality Policy and procedures. The Quality Lead is responsible for Audit Management, Deviation and CAPA Management, Document Control, and other Quality Management System activities. Developing, managing, and executing quality management processes to ensure compliance with regulatory requirements is a key aspect of this role. Essential Functions: - Maintaining awareness of and ensuring adherence to applicable SOPs/controlled...

Schaeffler is a dynamic global technology company with a rich history of private ownership and entrepreneurial spirit. As a partner to major automobile manufacturers, aerospace, and industrial sectors, we offer numerous development opportunities. We are currently looking for a dedicated and detail-oriented Process and Customer Quality Engineer (QMPP) for Schaeffler India Ltd (formerly Vitesco Technologies) at the Pune, Talegaon Plant. This role is crucial in ensuring that our products meet internal specifications and customer expectations. The ideal candidate will lead continuous improvement efforts, manage quality systems, and collaborate with various departments to enhance product and proc...

Implement & maintain quality systems in compliance with cGMP & regulatory norms.batch review, product release,change control,QA documentation,audits, manage deviations, CAPA,OOS investigations.quality metrics & APQR & regulatory inspection readiness.

As Manager 2 in the Corporate Quality department at SUN Pharma, you will be responsible for overseeing the quality aspects of contract manufacturing organizations (CMOs) involved in manufacturing site transfer products for the US market. Your primary focus will be to ensure compliance with SUN Pharma Quality and Compliance Standards as well as global regulatory requirements. Your essential job functions will include monitoring and overseeing activities at CMO sites to ensure adherence to SUN Pharma standards and regulatory guidance. You will conduct regular oversight visits, prepare visit reports, and serve as the main point of contact for coordination between SUN site, commercial team, corp...

As a Process and Customer Quality Engineer (QMPP) at Schaeffler India Ltd (formerly Vitesco Technologies) in Pune, Talegaon Plant, your role is vital in ensuring that our products meet both internal specifications and customer expectations. You will have the opportunity to lead continuous improvement efforts, manage quality systems, and collaborate with various departments to enhance product and process quality. Your key responsibilities include leading systematic problem-solving for internal process rejections, defining and implementing a roadmap to achieve quality KPIs, resolving top issues using a structured approach, planning and executing manufacturing quality audits, leading product-pr...

The Quality Compliance Senior Manager plays a crucial role in the Clinical & Research Quality (CRQ) team for the R&D Quality Organization at Amgen. The CRQ team ensures that research and development activities are conducted ethically and responsibly, meeting the highest standards of quality and compliance to keep patients safe and protect their welfare. This position involves providing leadership to maintain excellence in R&D Quality Processes, mentoring Amgen staff in India, managing day-to-day activities, and ensuring compliance with regulations globally. Additionally, the Quality Compliance Senior Manager will support the digital quality management system (DQMS) and provide end-to-end qua...

Track significant deviations for on time closure and associated CAPAs Preparation of slides for management meetings Scheduling meetings with CFT of all BBL sites Review of non significant investigations

As a Clinical Quality Assurance professional at WPPL, you will play a crucial role in ensuring the establishment, implementation, and maintenance of processes required for the Quality Management System. Your responsibilities will include reporting on the performance of the quality system, planning and executing clinical activities, and conducting various audits across departments. You will be responsible for reviewing equipment installation, qualification, calibration, and preventive maintenance in the clinical department, ensuring compliance with relevant SOPs and guidelines. Additionally, you will review clinical data, pharmacokinetic analysis, statistical output, and statistical analysis ...

Company Description LOZEN PHARMA is a contract development and manufacturing organisation specializing in lozenges and throat pops. They offer end-to-end pharmaceutical services from new product development to production and quality control. The manufacturing facilities are GMP certified by WHO, NSF, and SRA bodies. LOZEN PHARMA has a global presence, supplying over 150 products to 35+ countries. Location - Savanur (Hubli) Department - Warehouse / Stores Yrs of Experience - 14+yrs Job Roles & Responsibility - -Ensure procurement of Raw material and Packing material as per production planning and to avoid a stock out situation. -To coordinate with vendors and Production department for timely ...

As the Quality Management Systems (QMS) Manager at our corporate departments, you will play a vital role in ensuring the highest standards of quality across all aspects of our operations. Your responsibilities will include reviewing, approving, and closing change controls, deviations, and incidents for the corporate department. Additionally, you will be tasked with reviewing change controls for oral dosage forms across all Hetero formulations facilities. Your role will also involve reviewing Process Validations, Continued Process Verification, Cleaning Validations, Hold time studies, and Annual Product Quality Reviews (APQR) across our formulations facilities. You will be responsible for coo...

Job Title: ISMS (Information Security Management System) Location: Airoli, Navi Mumbai Key Responsibilities: ISMS Implementation & Management: Develop, implement, and maintain the ISMS framework, including policies, procedures, and guidelines based on ISO 27001 and other relevant standards. Conduct regular risk assessments to identify vulnerabilities and recommend appropriate controls to mitigate information security risks. Coordinate with other departments to ensure adherence to ISMS protocols and align information security with business goals. 2. Compliance & Audits: Ensure the organization complies with regulatory requirements related information security, privacy, and data protection. Le...

Job Summary 1. Execute Shift Leader routines: 2. Execute LSW Routines and discusses with Production Manager/ Head of Production Segment upon problems and/or deviations in routine fulfilment 3. Identify systematic failures and initiate Problem-Solving measures 4. Coordination, support and coaching of the Line Leader in order to achieve the targets for internal production KPI(PPM, Scrap Rate, OEE ,Rejection Rate, FPY, etc) 5. Performs deviation management to react on abnormalities of targets for Safety eg, incidents; Quality eg, FPY, PPM, Rejection rate; Productivity eg, OEE, line output; Cost: Scrap 7. Ensure data are updated in the frequency as required in the LIB 8. Participates and generat...

Job Title: ISMS (Information Security Management System) Location: Airoli, Navi Mumbai Key Responsibilities: ISMS Implementation & Management: Develop, implement, and maintain the ISMS framework, including policies, procedures, and guidelines based on ISO 27001 and other relevant standards. Conduct regular risk assessments to identify vulnerabilities and recommend appropriate controls to mitigate information security risks. Coordinate with other departments to ensure adherence to ISMS protocols and align information security with business goals. Compliance & Audits: Ensure the organization complies with regulatory requirements related to information security, privacy, and data protection. Le...

Experienced QA Manager to oversee&manage QA operations our pharmaceutical manufacturing unit.Ideal candidate will ensure compliance with GMP, WHO other regulatory standard,while developing &maintaining QMS Share your Resume to hrd@stedmanpharma.com

Roles and Responsibilities Ensure compliance with regulatory requirements, company policies, and procedures related to production quality management systems (QMS). Develop and maintain documentation for change controls, deviation management, and non-conformance reporting. Collaborate with cross-functional teams to resolve issues related to product quality, process validation, and equipment calibration. Desired Candidate Profile Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma). Minimum 1-4 years of experience in the pharmaceutical industry with expertise in OSD formulation manufacturing. Strong understanding of BMR/BPR regulations and ability to apply them ef...

Information Security GxP Specialist What you will do Let’s do this. Let’s change the world. In this lead role you will support the GRC Governance / Policy & Audit team working closely with Technology teams to help ensure that GxP controls are in place, GxP deviations are managed and monitored, and security standards are met. The GxP Specialist will assist in owning and maintaining GxP deviation records, performing GxP assessments, managing controlled documents, and supporting regulatory compliance efforts. Roles & Responsibilities: GxP Governance Leadership: Support the GRC organization in leading a team of GxP and/or policy analysts performing tasks related to governance, GxP deviation mana...