345 Deviation Jobs - Page 2

Manager - Quality Control (Formulations) 10 to 15 years of experience in Pharmaceutical Industry especially in Formulations Unit. Should have experience in successfully handling Quality Audits. Thorough knowledge in all types of Analytical instruments, analytical methods, HPLC, Method validation and method development etc., Should possess profound knowledge and skills in OSD/Formulations products. Total Quality Management (TQM), preparation and successful implementation of SOP's. Should lead a team in QC department and responsible for TQM. Sound working knowledge in MS Office and computer skills. Responsible for day-to-day and periodical MIS reports. Coordination with Production, QA and othe...

We are looking for a proactive and detail-oriented Assistant Manager QMS to support our Engineering team and ensure compliance with global regulatory standards. The role involves managing documentation, audits, deviations, and continuous improvement initiatives in alignment with company and regulatory requirements. Role & responsibilities Responsible for incident Investigation, Root Cause Identification, impact evaluation and defining CAPA. Responsible for CAPA extrapolation, CAPA tracking and implementation. Responsible for CAPA & Change Control effectiveness check. Responsible for preparation of Quality documents. Support OOS, OOT & Market Complaint investigations. Responsible to follow an...

Role & responsibilities: 1. Lead investigations into quality incidents, deviations, and non-conformances within our manufacturing processes. 2. Conduct thorough root cause analyses to identify the underlying causes of quality issues and develop effective corrective and preventive actions (CAPAs). 3. Collaborate closely with cross-functional teams, including production, engineering, and quality control, to drive investigations to resolution. 4. Utilize scientific and statistical methodologies to support investigations and determine appropriate corrective actions. 5. Provide technical expertise and guidance to junior investigators and ensure investigations are conducted in compliance with regu...

Job Description JOB Responsibilities: - Location: Ahmedabad 1. Ensuring the GMP compliance at CMO and Release of batch manufactured for US market at CMU. 2. Monitoring of process starting from dispensing to packing including witness analysis of Lupin products manufactured at CMO for US market and Domestic market. 3. Handling of market complaint with root cause identification and ensuring the CAPA implementation. 4. New product review to be carried out at manufacturing site after availability of all the documents. 5. Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished p...

Job Title: Senior QC + QA Trainer (Pharma / Biotech Laboratory) Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced and knowledgeable QC + QA Trainer to design, develop, and deliver technical training programs for quality control and quality assurance teams. The trainer will be responsible for building competence in analytical testing, documentation practices, GMP compliance, and QA/QC systems within a regulated laboratory environment. Key Responsibilities: Training & Development Develop and deliver structured training programs on QC laboratory techniques, QA systems, and GMP compliance . Conduct practical laboratory training (analytical instruments, wet che...

Required Analysts for Quality Control Department We are having excellent job opportunities for Quality Control (QC) Department at Amneal Pharmaceuticals, SEZ Matoda Injectable. REQUIREMENT FOR INJECTABLE QUALITY CONTROL DEPARTMENT Designation: Officer/ Sr. Officer /Executive/ Sr. Executive Department: Quality Control Qualification: Diploma/ B.Sc./ M.Sc/ B. Pharm/ M. Pharm Total Experience: 02 to 05 years (Pharma experience only-Injectable is mandatory) Desired Profile: GLP : Operation and Calibration of HPLC (Waters and SHIMADZU), GC, UV, FTIR, K/F, AAS, IC. RM-PM : Analysis of Raw material and Excipients and handling of HPLC (Waters and SHIMADZU), GC(Agilent), UV, FTIR, K/F, AAS, IC. IP-FP ...

Job Title: Manager - Regulatory Affairs / Quality Assurance Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 10-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: Bachelors or Masters in Pharmacy M.Sc in Biotechnology, Microbiology, or a related field Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager QA / Regulatory Affairs , you will play a pivotal role in ensuring that our vaccine , injectable , and sterile pharmaceutical products meet global regulatory requirements and quality assurance (...

1. Quality System Management: Establish, implement, and maintain the Quality Management System (QMS) as per cGMP, WHO, and regulatory norms . Oversee activities related to change control, deviations, CAPA, OOS/OOT investigations, and risk assessments . Ensure all QA processes align with company policies and current regulatory requirements. 2. Documentation & Compliance: Review and approve SOPs, BMRs, BPRs, validation protocols , and analytical reports. Ensure all documentation complies with Good Documentation Practices (GDP) and data integrity requirements. Supervise document control , issuance, archival, and version management systems. 3. Batch Release & In-Process Quality Assurance: Ensure...

Be responsible to lead downstream manufacturing compliance. Ensure quality management systems in line with cGMP and regulatory requirements and handling training requirements Handling Change control management system including CCF impact assessment, preapproval, cross functional CCF evaluation, monitoring of closure of change controls and change control action item. Coordinate with investigator in identifying appropriate CAPA and tracking for closure of the CAPA. Responsible for the review and approval of Master manufacturing records for the commercial batches. Responsible for review and approval of scale up, exhibit, intended and Process validation master manufacturing records. To review an...

Operator Reporting to Officer / Sr. Officer / Executive / Sr. Executive. To check & use proper earthing if required before starting activity. To clean equipment as per Standard Operating Procedure. To check & ensure cleaning of equipment as per status before to start activity. To Charge the raw material as per BMR. To carry out processing as per BMR & update the status board as per current status. To update the equipment use logbook & balance use record as per current status. To check the reading of differential pressure, temperature and humidity and record in the respective log book. To monitor environmental parameter such as differential pressure, temperature and humidity, wherever applica...

Role & responsibilities: Preparation and review of SOP. Preparation and monitoring of change control, deviation control. Review and approve the Standard Operation Procedure, Product Quality Reporting System (PQRS), Change control, Deviation controls/Analytical Protocols/Stability protocols/Qualification and validation protocols and reports. In-Process checking during online activities. To ensure timely submission of audit compliances for the deficiency during the inspections/audits Monitoring of GMP compliance. Review of quality documents and analytical data as per pharmacopeia specification, STP, batch card, stability finish product, packaging materials for the purpose of compilation of dos...

Job Description -Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished products for US and IRF market at CMU. -Release of batch manufactured for US and IRF market at CMU -Handling of market complaint with root cause identification and CAPA implementation -Review of documents such as executed BPR, Analytical records, Change Controls, Deviations, OOS, Process Validation, Cleaning Validation, Equipment Qualification, stability data and CAPA for products of US & IRF market. -Provide required documents to Regulatory affairs for variations and updates -Monitoring of process st...

Greetings from Themesoft! We're looking for QMS Support Consultants to join our dynamic team in Chennai . This role focuses on providing L2/L3 functional and technical support for enterprise Quality Management Systems (QMS) , including TrackWise and Veeva Vault Quality , ensuring minimal disruption to critical Quality and Manufacturing operations. Location: Chennai, India Experience: 610 Years Shift Requirement: Must be flexible to work in shifts Notice Period: Immediate to 10 days joiners Expertise Skills: TrackWise , Veeva Vault Quality, Deviation , CAPA , Change Control , Audit Management . Key Responsibilities: Application Support: Handle L2/L3 support for QMS platforms (TrackWise, Veeva...

Title: Corporate Quality Projects - LIMS Business Unit: Corporate Quality IT Job Grade Executive / Sr. Executive Location: Vadodara Key Responsibilities At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Position Summ...

Roles and Responsibilities Conduct stability analysis of APIs, excipients, and finished products according to cGMP guidelines. Perform method validation, cleaning validation, and equipment qualification activities as per SOPs. Ensure compliance with regulatory requirements by maintaining accurate records and documentation. Collaborate with cross-functional teams to resolve deviations and implement corrective actions. Participate in audits conducted by USFDA, WHO, EDQM, and other regulatory bodies.

Exciting Career Opportunities at Natco Pharma Limited for the following requirements Open Positions: Operators & Supervisors OSD Production & Packing (Onco & Non-Onco) Experience: 0 to 8 Years (Freshers graduated in 2024/25 are eligible) Qualifications: I.T.I / Diploma / B. Pharmacy Key Responsibilities: Operate equipment's in Granulation (RMG, FBD, ACG, GEA), Compression (GEA, Sejong), Coating (NEOCOTA), Capsule Filling (Bosch, MG02), Blister Packing (CAM NMX, HV1, BQS, IMA/ACG), and Bottle Packing (CVC, Optel) lines. Supervise production lines, including Granulation, Compression, Coating, and Packing (Blister/Bottle). Good verbal and written English communication skills 2. Operators & Supe...

Job Description: Require experience in IPQA, IPQA (API), Qualification (API), Validation (API), Analytical QA, APQR, Stability Studies, regulatory affairs, OOS investigation, Risk Assessment, Market Complaint, QA Documentation, Exposure in QMS, Deviation, CAPA etc with Trackwise system. Qualification - B.Sc./M.Sc./ B.Pharma/ M.Pharma. Experience - 04 to 09 Years. Role & responsibilities Preferred candidate profile The candidate from API background Only to apply. Send CV with Sub : Forwarding CV for position of QA dept to jagpal.dewal@ipca.com

Title: Executive - R&D Quality Business Unit: R&D Quality Job Grade G12A Location: Vadodara Key Responsibilities At Sun Pharma, we commit to helping you “ Create your own sunshine ”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Position Summary – List of Responsibilities: To Rev...

Roles and Responsibilities Conduct BPR review, BMR review, Change Control, Cleaning Validation, Deviation investigation, IPQA activities, Process Validation, QMS implementation, and Quality Assurance for Formulation Sterile Injectables. Ensure compliance with regulatory requirements and company policies. Collaborate with cross-functional teams to resolve quality issues and improve processes. Develop and maintain documentation related to quality control procedures. Participate in audits and inspections conducted by regulatory authorities. Desired Candidate Profile Strong understanding of Good Manufacturing Practices (GMP), Current Good Laboratory Practice (cGMP), and Quality Management System...

The QA Executive ensures implementation and maintenance of Quality Assurance systems as per GMP and GDP standards, maintaining documentation accuracy, adherence to procedures, and continuous improvement in product quality and reliability.

Initiate and conduct investigations associated with sterile injectable product manufacturing and processing. To identify true root causes through different tool and identify SMART CAPAs. Review of investigations to ensure content of report in compliance to the site procedure requirements for its completeness, accuracy and adequacy. To investigation market complaints, identify the root causes and respond to partner/customer. To monitor overall investigations matrixes and present to management time to time. Responsible for Quality compliance within the investigation process. Actively involved in regulatory audits as a process SME. Provide management timely updates on critical events. To sustai...

Job Title: Deputy Manager- Formulation Location: Govandi, Mumbai Department: Corporate Quality Assurance Qualification, Experience and Technical Competency: 1. Master’s Degree in Pharmacy or Science or equivalent scientific field. 2. Minimum 10 years experience in Pharmaceutical Industry (Strong background of Formulation industry with 2 to 3 years experience in Quality Control.) 3. Work experience in Regulatory Sites (USFDA, MHRA, EU GMP) 4. Knowledge of current Good Manyfacturing Practices (cGMP), Quality Management Systems (QMS) and regulatory guidelines. Key Requirements: Responsible for Quality Functions across Own Sites and Contract Sites with adherance to cGMP, Regulatory standards and...

Senior Manager 1

• Develop and maintain databases by acquiring TB-related data from primary and secondary sources, ensuring compatibility with the Nikshay portal. • Design and implement data storage solutions that facilitate efficient retrieval and analysis of TB- related data. • Generate regular and ad-hoc reports, dashboards, and visualizations to provide a clear view of TB program performance to stakeholders, with specific focus on data from the Nikshay portal. • Conduct regular audits of TB data entered in the Nikshay portal to ensure accuracy, completeness, and reliability. • Develop and enforce data quality metrics and standards specifically tailored to TB data to improve overall data integrity. • Prov...

Job Description: Senior Consultant Pharmaceutical QMS GxP We are seeking a highly experienced IT Consultant 10 years to lead the design and implementation of Quality Management Systems QMS in GxP regulated pharmaceutical environments This role combines deep expertise in business analysis and eQMS implementation with strong advisory capabilities in process harmonization and regulatory compliance As a key member of our Life Sciences R D consulting team you will play a pivotal role in delivering scalable compliant QMS solutions You ll lead quality initiatives facilitate cross functional workshops and help shape global quality processes aligned with regulatory standards such as ICH FDA EMA MHRA ...