245 Deviation Jobs - Page 4

As a valuable member of our team in the pharmaceutical industry, you will be responsible for various key tasks including CAPA, OOS, Deviation management, SOP's generation, and ensuring Validation, GDP, GMP compliance. Your role will play a crucial part in maintaining high quality standards and regulatory requirements. This is a full-time position with a day shift schedule. The ideal candidate should have a total work experience of 1 year, preferably within the pharmaceutical sector. The work location for this role will be in person, providing you with the opportunity to actively engage with the team and processes.,

As the Head of Corporate Quality in the Global Supply Organization at our base location in Navi Mumbai, India, you will play a crucial role in leading the development and execution of quality assurance strategies that are in line with our company's long-term objectives. Working closely with the Chief Technology Officer and the GSO Leadership Team, you will be responsible for ensuring the implementation of robust quality management systems, regulatory compliance, and driving continuous improvement in operational performance. Your responsibilities will include establishing best-in-class quality goals, analyzing quality metrics trends, implementing problem-solving strategies and system enhancem...

13-15 years of experience with QMS Activity and all QA activities. Process validation cleaning validation Monitoring of IPQA Data Integrity

Job Description To review/approval/closure, rejection/drop (if required) of Quality system documents such as Deviation, change control, CAPA, OOS, OOT, Re-process & Re-work, market complaint, market returns & LIR. To ensure & handle the investigation for Out of Specification Results, OOT, Deviations, Product failures and Market Complaints are adequately performed and documented with appropriate Quality Risk Assessment activity, Corrective and Preventive Actions based on the results of the investigations are identified and implemented. To preparation review & Approval of Quality system trend. To verify In-process Quality Assurance during production activity and sampling at different stages of...

Job Title : Assistant Manager Or Deputy Manager Job Location : Hyderabad Department : QA Reports to : HOD Job Objective : To perform the QA activities in view of system upgradation and improvement in the existing procedures. Job Role: 1. Execution & co-ordination for investigations, Identification of root cause along with assignment of adequate CAPAs for Returned material, Incidents, Deviation, OOS, OOT, complaints & other quality events. 2. Logging, Review & Closing of the change controls and CAPAs along with implementation of CAPA and its effectiveness verification as applicable. 3. Responsible as site representative during Regulatory Audits and customer inspections to co-ordinate with the...

Responsible for leading production operations, coordinating production staff and equipment, ensuring product quality and profitability, and overseeing and managing the production operations involved in injectable products.

Position: Officer/Sr. Officer Department: Quality Control-Chemical Qualification: B.Sc/M.Sc (Chemistry) Experience Required: 4 to 7 years in Pharma Industry (Sterile Plant) (Injectables) Location : Vadodara Job Description: Preparation of SOP, Specification, STP, ARDS, Protocol, Reports, Stability summary report, Miscellaneous document and analytical method validation inline of applicable pharmacopoeia and ICH guideline. To Initiate the QMS element as per requirement. Handling of QMS related activity i.e OOS, OOT, Deviation, OOC, Change control and CAPA. Review laboratories equipment calibration and their preventive maintenance, working standards etc. Review and Implementation of Pharmacopei...

You will be responsible for reviewing R&D developmental data of ARD and PD including Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, and Study Reports to ensure accuracy, data integrity, and compliance with systems, procedures, and regulatory requirements. Additionally, you will review Technology Transfer documents such as Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications, and MOAs. Conducting routine laboratory rounds to ensure compliance with Good Laboratory Practices will be part of your responsibilities. You will also handle Change Controls, Deviations, I...

Responsible for overall Quality control laboratory Implementation of cGMP and good laboratory practices. Handling of laboratory incident, Out of calibration and deviation investigation. Conducted investigations on product/material test results failures and out of trends Review & approval of standard test procedure, specification Handling of laboratory incident, Out of calibration and deviation investigation. Making sure that all deviation, OOS,OOT, incident are investigated and closed before the release of the batch/material

Role & responsibilities Handled Microbiology QMS Activities. Should have experience in OOS,OOT protocol review Preferred candidate profile Male Candidate Preferred

Role & responsibilities Should Have Experience in Handling QMS in Quality Control Department. Handled OOS , OOT, Deviation, CC, Protocol Preparation Preferred candidate profile Male Candidates Preferred

Role & responsibilities IPQA:- Responsible for line clearance and in process checks of Production. Responsible for Sampling of in-process, Finished Product, control samples, stability samples, and Process Validation samples as per procedure. To ensure online rejection activities and environment monitoring in manufacturing and packaging areas. To conduct periodical log review. To review of batch documents (Batch Manufacturing, Batch Packaging records, and Quality Control analysis data of the batch). To ensure online documentation during manufacturing and packaging area. To prepare and review of Quality Assurance Standard Operating Procedures. To ensure Re-processing and Re-packing activity. R...

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

Job Title: Quality Engineer. Experience: 4 to 10 years Location: Mysuru Notice Period: immediate to 15 days Mandatory Skill: QMS, Capa, GMP/Gdp/ GLP, Change Control, Deviation, Sop Preparation JD : Good understanding of Pharmaceutical GMP/GLP/GDP practices. *Experience in Pharma QMS activities like, handling Change Controls, Deviations, vendor qualifications and SOP updates. *Understanding of Internal Audits and CAPA closures. *Supporting for Quality metrics program. *Proficient experience with MS-office is required. *Strong written and verbal communication skills are essential *Experience working with virtual teams • Understanding of ISO 9001:2015 is required. *Strong communication, teamwor...

Role Overview Responsible for qualification & calibration of Microbiology instruments and equipment as per procedures with QMS. Illustrative Responsibilities Ensure that qualification & calibration activities are planned and executed within time frame defined by the procedure and equipments are released on time as per the pre-defined schedule. Responsible for coordinating with lab supervisors / system owners for handling of any non-conformances or escalations Handling of QMS related activities like, Change control, CAPA and Deviation with its effectiveness check. Responsible for quality compliance activities for laboratory instruments qualification and calibration. Summarize, review, and rep...

Role & responsibilities BMR/BCR preparation and approval SOP preparation and approval Change control and Deviation handling OOS/OOT investigation & CAPA implementation Trackwise software and good Computer skill.

Oversees QC activities, staff training, SOPs, calibrations, GLP compliance, audits, records, and lab investigations (OOS/OOT) and aligns QC goals with production and ensures lab standards (candidates having approval from Raj. FDA will be preferred).

Looking for professionals with strong stakeholder management and communication skills, experienced in Application Periodic Review, CAPA, Deviation Management, Supplier Assessments, and direct customer interaction in regulated environments.

As a QA Executive, you will be responsible for various quality assurance tasks including Change Control, Deviation, Out of Specification, Market Complaint, Corrective and Preventive Action (CAPA), and Annual Product Quality Review. Additionally, you will be involved in Audit Compliance Report Preparation, Label compliance, Legal Metrology (Packaged Commodities), FSSAIs Labelling and Display Regulations, and implementation of GMP/GHP requirements in the food industry. You will be required to manage Calibration activities both internally and externally, Equipment Qualification & Documentation control, Process Validation Protocol & Report Preparation, and Cleaning Validation Protocol & Report P...

You are invited to a Walk-In Interview at Zydus Corporate Park in Ahmedabad on Saturday, 28th June 2025, from 10:00 AM to 03:30 PM. Zydus is a global healthcare provider focused on innovation and committed to enhancing healthcare therapies to create healthier communities worldwide. ### SAP S/4 HANA Opportunities: 1. **SAP FICO Consultant:** - **Experience:** Minimum 5 years in SAP FI, FM, PS, CO, and S/4HANA. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Responsible for designing and implementing SAP FI/FM solutions, integrating with MM, SD, and PPQM modules, and driving process improvements. 2. **SA...

Roles and Responsibilities Prepare BOQs, estimate quantities, and monitor progress against plans. Coordinate with site teams to ensure timely completion of civil works. Conduct rate analysis, prepare bills for subcontractors and contractors, and manage vendor payments. Review drawings, check technical specifications, and verify compliance with project requirements. Oversee industrial construction projects from planning to execution.

Overall handling of Quality Procedures & Quality Management System (QMS). Handling & Issuance of NCs, CAPA and Change Control. ISO Audits, PDI, BMR, Audit Documentation, Customer Audits Required Candidate profile BE/ Btech/ Diploma- Mechanical Engineering, Min. 1 year exp as Quality Executive/ Engineer in Medical Devices or Automotive Industry. Prior exp of handling Quality Procedures & QMS, CAPA, Audits.

Performing audits of all Dr. Reddy’s Laboratories manufacturing, packing, testing, development centers and distribution warehouses as per the audit schedule. Primarily performing internal audits of CTO, FTO and R&D Sites. Performing GAP assessment of the new/revised regulatory guidance documents, USFDA warning letters / form 483s to evaluate the current approved documents for compliance / improvements or requirement of new procedures and harmonizing and implementing the best practices across sites. Review of audit responses and tracking the CAPA generated out of internal audits, regulatory audits, customer audits, cross-applicable CAPAs through OCMS, Warning letters & 483 forms gap assessmen...

As a Shift Operation Engineer, your responsibilities will include handling the shift operation and completing related documentation as required by SOP. You will be responsible for achieving targeted production, ensuring smooth, efficient, uninterrupted, and trouble-free operation and maintenance of the water plant, HVAC, and other utility equipment as per SOPs. Implementing best practices to comply with quality, safety, and regulatory requirements will be crucial in this role. Your tasks will also involve preparing, ensuring, and monitoring compliance of SOPs and related documentation of the engineering department. Initiating Change controls and Deviations, CAPA in the electronic system as p...

Role & responsibilities Leads and optimizes QA function that supports organizations QMS in compliance with respective international regulatory requirements. • Hosting and support in external/client audits and regulatory inspections hosted by Auriga. • Audits and inspection handling. • Conduct internal system and process audits within Auriga systems. • Conduct external audits including the audit of vendors, clients and/or clients business partners and service providers. • Lead and manage a team of clinical audit professionals, providing guidance, training, and mentorship. • Support the operations team for adequate root cause identification, conducting gap analysis and implementation of correc...