335 Deviation Jobs - Page 2

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 ...

Job Title: Investigation Lead - Pharmaceutical OSD Location: Hinjewadi Job Summary: An Investigation Lead in the pharmaceutical industry plays a crucial role in overseeing and managing the investigation of deviations, non-conformances, quality issues, or potential risks that may arise during production, testing, or any part of the drug development and manufacturing processes. Their role ensures that investigations are conducted thoroughly, efficiently, and in compliance with regulatory standards. Below is an outline of the key responsibilities and competencies required for this role: Key Responsibilities: 1. Lead and Oversee Investigations Direct and manage investigations into deviations, no...

Key Responsibilities : 1. Documentation & Compliance Ensure compliance with cGMP, WHO, EU GMP, USFDA, and other regulatory requirements specific to injectable formulations. Review, control, and maintain SOPs, Quality Manuals, and other QMS documents. Control issuance, retrieval, and archival of GMP documents as per SOPs. 2. Deviations & CAPA Investigation and documentation of deviations, incidents, and non-conformances. Identify root causes using tools like 5 Whys / Fishbone analysis. Initiate, track, and ensure timely closure of Corrective and Preventive Actions (CAPA). 3. Change Control Review and manage Change Control records related to injectable manufacturing. Ensure impact assessments ...

Role : Executive Small Volume Parenteral Manufacturing Location: Ahmedabad Department: Injectable / Sterile Production Key Responsibilities: Production Operations: Plan, organize, and execute the manufacturing batches of small volume injectable products. Operate / supervise key equipment: vial/ampoule washing, sterilization (autoclave, filtration), filling, sealing, capping, tunnel sterilizer, lyophilizer (if applicable) etc. Ensure line readiness, material dispensing, line clearance before/after operations. Aseptic Process & Sterility Assurance: Maintain cleanroom operations, gowning, environmental monitoring, microbial monitoring. Ensure correct operation of aseptic filling / sterile filtr...

Job Title: DGM - R&D Quality. GCP QA Business Unit: Global Quality & Compliance Job Grade G8 Location : Baroda 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.” Key responsibilities: Implement GCP requirements as per...

Job Title: Senior Executive/Executive – MSTG Non-Orals Business Unit: R&D1 Regulatory Affairs Job Grade G12A/G11B Location Baroda 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.” JOB DESCRIPTION Process Development ...

As the Associate General Manager – Governance (City) at Livspace, you will serve as the control anchor for all governance-related practices in your city. Youll ensure that processes, policies, and compliance mechanisms are implemented and followed across functions like design, project execution, customer experience, and especially partner/vendor management. This is a strategic and hands-on role that ensures operational discipline at the city level. You will closely work with internal teams and external partners to identify gaps, mitigate risks, and uphold Livspaces governance and compliance standards. Roles and Responsibilities City Governance & SOP Adherence Drive compliance with Livspaces ...

Documentation- BMR review, Day to day documentation, Qualification, Validation, Deviation ,Change control, OSS, Incident, Market complainant, CAPA.

Job Title: Senior Officer – Process Engineering Business Unit: Engineering Job Grade G12B Location : Gangtok 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.” Key responsibilities: Execution of Breakdown maintenance...

Candidate should be able to achieve the organizational goal in maintaining the Quality Management system of API industry. He should be able to execute various function QMS like CAPA, Deviation, CC, Risk assessment ETC Candidate Profile : - Should have minimum Two years experience. He should be able to work with the team and be willing to take initiative & challenge for completing the task timely Qualification : - B Pharm/B Sc M Sc./M Pharm

Dear Candidates, We are looking for our USFDA & EUGMP approved plant located at Rasayani, Patalangana MIDC for QMS -Sr. Officer/ Executive. Role & Responsibilities 1.Coordination and evaluation of QMS (Change control, Deviation, CAPA 2.Training Management- Approval of training, allocation of training followed by tracking. 3. New product initiation and evaluation/tracking. 4. Preparation and review of sectional and cross functional department SOPs 5. To carry out all responsibilities assigned by section head as per cGMP, GDP and zero data integrity. Preferred candidate profile: Candidate must have experience in Pharma Formulation Company and exposure in Regulated Market (USFDA & EU - GMP). In...