544 Oos Jobs

Responsible for Overall site QA compliance activities and drive the organization towards quality improvements Handling of Deviation, Change controls, OOS, OOT and CAPA including investigations and impact assessments

Role & responsibilities 1 Preparation of standard operating procedure. 2 Preparation of quality documents. 3 Initiate / review of change control system. 4 Initiate / review of deviation. 5 Initiate / review of CAPA. 6 To control, issue, retrieve, retention and disposal of GMP documents as per standard procedure. 7 Review of MFR/BMR/BPR/ECR. 8 Review of validation protocols and report. 9 To participate in investigation of OOS for RM/intermediate/FP. 10 To participate in market complaint handling. 11 Review of vendor qualification documents. 12 Review of executed manufacturing and analytical records. 13 Preparation of annual product quality review. 14 To take plant round and ensure compliance ...

Responsibilities: Review and approve batch records, laboratory data, and other relevant documents related to the manufacturing process. Ensure all operations comply with GMP guidelines and internal quality standards. Conduct internal audits to assess adherence to GMP, standard operating procedures (SOPs), and other regulatory requirements. Participate in the review and approval of finished product batch records and assist in product release processes. Investigate and manage deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out of Specification) results in a timely manner. Support the quality control laboratory in ensuring that all testing is performed in accordance with regulat...

Review and analyze health data to ensure accuracy and compliance with regulatory requirements.Collaborate with cross-functional teams to identify and resolve data discrepancies.Develop/implement effective data review processes to improve quality Required Candidate profile Strong understanding of employment firms and recruitment services.Excellent analytical and problem-solving skills, with attention to detail and the ability to work independently.

Review and analyze health data to ensure accuracy and compliance with regulations.Identify trends and patterns in health data to inform business decisions.Collaborate with cross-functional teams to develop and implement data-driven solutions. Required Candidate profile Strong understanding of health data principles and regulations.Experience with data analysis and interpretation techniques.Excellent communication and collaboration skills.

Responsibilities: Maintain database on regular basis. Verify data and correct database. Review and verify the entries. Respond to queries for information and access relevant files Comply with data integrity and security policies Roles in Production Planning as well as sales as Back Office candidates. Required Skills: Must be excellent in written and spoken English; net savvy and adept at computer skills especially on ERP. Logical thinking. Organizing. Good communication. Required Qualification: - Any Computers Related

About The Role Job Title - Internal Audit Analyst Management Level :11 – Analyst Location:Bangalore Must have skills: Chartered Accountant with 2 - 3 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Good to have skills: Internal Audit experience with Big 4 or a global organization Job Summary :An agile, highly motivated, innovative thinker with a background in audit, risk, or compliance looking to join a fast-paced, global Internal Audit department that has embraced transformative capabilities including advanced analytics, dynamic risk assessment, and automation to retain its role as a trusted advisor to the business. You ...

Conduct thorough reviews of ECR data to ensure accuracy and compliance with company standards.Identify and report any discrepancies or errors in the ECR system.Collaborate with cross-functional teams to resolve issues Required Candidate profile Strong understanding of ECR systems and data analysis principles. Excellent analytical and problem-solving skills with attention to detail.

Conduct thorough reviews of ECR data to ensure accuracy and compliance with company standards.Identify and report any discrepancies or errors in the ECR system.Collaborate with cross-functional teams to resolve issues Required Candidate profile Strong understanding of ECR systems and data review principles. Excellent analytical and problem-solving skills with attention to detail. Ability to work effectively in a fast-paced environment

Responsibilities: Individually handling department & manpower. Strong leadership skills to guide, supervise work activities, and help team members develop their skills. Work allocation / Planning and Review of documents. Preparation of SOP, Specification, Standard Test Procedures (STP), Raw Data Sheet (Protocol), Excel worksheet validation etc. Preparation and review of Analytical Method Validation protocol & Report. Preparation and review of equipment qualification documents. Handling of QMS documents like Change control, Deviation, Incidents, OOS, OOT etc. To investigate, identify the root cause and troubleshoot. To maintain GLP and discipline in the QC department. Required Skills Change C...

Conduct thorough reviews of ECRF data to ensure accuracy and compliance with regulatory requirements. Identify and report any discrepancies or issues found during data review. Collaborate with cross-functional teams to resolve data-related issues. Required Candidate profile Strong understanding of ECRF data management principles and practices. Excellent analytical and problem-solving skills, with attention to detail.

Responsibilities: Ensuring Compliances: Quality Assurance professionals play an important role in ensuring that all processes & product comply with QMS/IMS and other relevant regulations. Quality Control: Quality Assurance professionals involved in the development, maintenance & implementation of procedures and system in QC and production. Documentation: QA professionals review and approve documents such as SOPs, batch record & other quality related documents. Audits & inspections: They conduct audits & inspections to ensure compliances with regulations & identify areas for improvements. Investigation & Corrective Action: They investigate deviations or non-conformance & implement corrective ...

We are looking for a skilled SAP CRM-C4C professional with 9 to 20 years of experience. The ideal candidate will have expertise in SAP C4C and be able to work effectively in a fast-paced environment. Roles and Responsibility Manage and implement SAP C4C solutions for clients. Collaborate with cross-functional teams to identify business requirements and develop solutions. Provide training and support to end-users on SAP C4C functionality. Troubleshoot and resolve technical issues related to SAP C4C. Develop and maintain documentation of SAP C4C configurations and customizations. Ensure data integrity and security in SAP C4C implementations. Job Requirements Strong knowledge of SAP C4C modules...

As a member of ACG Corporate, your primary responsibilities will include: - Prepare and carry out tests like MLT, Water analysis etc in Micro Lab - Ensure proper documentation - Develop and establish testing procedures - Maintain proper records - Maintain work space - Develop and sustain Quality culture across the plant - Establish a review mechanism to constantly upgrade and standardize the process In your functional core role, you will be responsible for: - Reviewing customer quality complaints (includes complaint investigation, root cause analysis and identifying the CAPA) - Ensuring closure of complaints in defined timelines with implementation of CAPA - Ensuring sustainability of QMS (D...

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...

Handling of Manufacturing Compliance i.e. IPQA Activity Handling of QMS Documents like CAPA, and OOS and Change control Handling of APQR Handling of Batch release activity Good in communication skills Exposure of Regulatory audit

Job Title : Reporting Analyst Location: Kochi Terms: Full Time Requirement : Need to work in nightshift and Weekend if applicable About the Role : An Underwriter is the person who decides whether or not to insure risks for which request has been submitted Underwriter s task is to evaluate a risk and make decision whether or not to provide the proposal for insurance after review the document which has been shared along with submission Responsibilities : Assign tasks need to finish within deadline Maintain the quality in each task

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 (...

Walk-In Interview Date : 02nd November 2025 (Sunday) Timing : 9.00 AM to 2.00 PM Venue : Umedica Laboratories Pvt, Ltd. Plot No 221,221/1 II Phase GIDC Nr Morarji Circle, Vapi 396195. 1. Tablet Manufacturing Department: Ability to handle process like Dispensing, Granulation, Compression, Coating, SOPs preparation, well versed with ALCOA & GDP principles. QMS Manufacturing investigation (OOS/OOT/Deviation/CAPA),Training.) Position: Officer to Sr. Executive Qualification: M.Sc. / B.Pharm / M.Pharm No. of Vacant Position: 10 Experience: 2 to 8 years To Operate Granulation lines (RMG/FBD/FBP/Roll Compactor), Automatic Compression Machine (PLC/SCADA based Cadmach & Fluid Pack), Coating (Kevin & G...

Key Responsibilities: Preparation, review, and control of Master Formula Records (MFRs) and Batch Manufacturing Records (BMRs). Identification, drafting, review, and periodic revision of Standard Operating Procedures (SOPs) across departments. Compilation and preparation of Annual Product Quality Review (APQR) reports. Preparation, review, and execution of Qualification & Validation documents (equipment, utilities, process, cleaning, etc.). IPQC management ensure in-process checks are conducted as per defined procedures and documented appropriately. Ensure timely product release as per defined process and quality requirements. Work on company-wide quality strategies aimed at reducing non-com...

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...

Utility Operator HVAC / Water / Electrical (01 Position) based in Vapi, Gujarat. The ideal candidate brings 5 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvemen...

The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Plan resources, ensure statutory compliance, drive traini...

The ideal candidate brings 5 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Own production execution and shift supervision; ensure line clea...