27 Audit Trail Jobs

As a Commission & Qualify professional, your role involves conforming Systems, Equipment, and Plants to pre-approved Site Acceptance Test (SAT) Protocols at the Customer's Site. You will be accountable and responsible for the following key activities: - Coordinate with clients for SAT activities, plans, and execution. - Coordinate with the team to resolve site/service issues and provide necessary guidance. - Review site activities according to the given schedule and escalate if there are delays. - Manage site costs and drive continuous improvement processes. - Manage the team, including resource planning, appraisal, training, and grievance handling. - Carry out Commissioning, Site Piping, In...

Role & responsibilities : Responsible for investigation of incidents, OOS, OOT, OOC & Deviation in Laboratory. Responsible for Review and closure of investigation of incidents, OOS, OOT, OOC & Deviation in Laboratory. Responsible for initiation & closure of Change Control, Deviations, CAPA in QEdge Software. Responsible for Review of Standard Operating Procedures and Standard Test Procedures. Responsible for preparation of Protocols, Reports and Annexures Investigation & Documentation. Responsible for Review of analytical documents, and audit trials as per 21 CFR part 11 compliance. Deep understanding of GMP, GLP, ISO 17025, regulatory guidelines, QMS, HPLC, GC, data integrity. Preferred can...

As a Quality Control Analyst at Piramal Critical Care (PCC), your primary responsibility is to complete assigned tasks and ensure training on activities as instructed by the supervisor or Head of Quality Control (HOD-QC) before execution. Your duties include reviewing data related to packing materials, raw materials, stability samples, in-process and finished products. Additionally, you will be responsible for reviewing Qualification, Validation, Calibration data, Procedures, and Audit Trails in a timely manner. If you identify any unsafe conditions or acts within the laboratory, you must report them to the supervisor or HOD-QC and ensure their resolution. Key Responsibilities: - Receive and...

We are looking for highly experienced SAP QM Architects with strong techno-functional expertise to lead complex implementations and product innovation initiatives within GxP-regulated pharma, life sciences, or healthcare environments. Key Responsibilities Lead end-to-end solution design and implementation of SAP QM within S/4HANA environments. Work extensively on Inspection Planning, Sampling Procedures, Results Recording, CAPA, COA generation, Stability Management, and Quality Notifications. Drive product development, co-innovation initiatives, accelerator creation, and reusable solution components. Ensure compliance with GxP, audit trail requirements, and maintain full validation documenta...

As a Business Process Analyst at our company, you will play a crucial role in driving operational efficiency and digital transformation initiatives. Your responsibilities will include: - Collaborating with Account Leaders and Delivery Managers to understand operational challenges and improvement opportunities. - Analyzing current processes, identifying inefficiencies, and proposing automation or optimization solutions using internal platforms such as Microsoft Power Platform and M365 Copilot. - Creating compelling business cases with ROI analysis, cost-benefit evaluation, and risk assessment to support project initiation and funding. - Driving the approval process with internal governance te...

As a Business Analyst in our company, you will play a crucial role in driving operational excellence and digital transformation. Your responsibilities will include: - Collaborating with Account Leaders and Delivery Managers to understand operational challenges and improvement opportunities. - Analyzing current processes, identifying inefficiencies, and proposing automation or optimization solutions using internal platforms such as Power Platform, M365 Copilot, etc. - Creating compelling business cases with ROI analysis, cost-benefit evaluation, and risk assessment to support project initiation and funding. - Driving the approval process with internal governance teams, ensuring alignment with...

You will be responsible for performing In-Process Quality Assurance (IPQA) activities at the shop floor during various stages of sterile manufacturing and packing. This includes conducting sampling at each stage or when necessary during product manufacturing, filling, and packaging processes. Additionally, you will be required to perform in-process checks of manufacturing, filling, and packaging activities. After the visual inspection of products, you will conduct Acceptable Quality Level (AQL) inspections. It will also be part of your duties to carry out audit trails, electronic data reviews batch-wise and as per the schedule. You will manage control samples and stability samples. Moreover,...

If you interested, please share your details below Email ID : renu.kumari@adecco.com Contact : 6364920532 ( Watsapp) Role & responsibilities To work along with IT-QA Team and Business Project Manager in defining technical controls & compliance requirements to the computerized systems to prevent Data Integrity breaches. To ensure technical controls are effectively implemented across Manufacturing & Quality IT applications. To ensure Audit Trail and Electronic data review of IT systems through Review by exception’ rule to enhance overall compliance on generated & reported data. Preparation and review of the Validation deliverable (i.e. VP, URS, FS, FRA, IQ, OQ, RTM, VSR). To perform Periodic r...

This is where your work makes a difference. At Baxter, we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. He...

As a Senior Specialist in Quality Assurance within the IT Quality organization, you hold a leadership role responsible for providing quality oversight and guidance on risk-based validation and Computer Software Assurance (CSA) for GxP computerized systems and to support the program management activities including managing the strategic goals, key performance indicators (KPIs), analyzing data to identify areas for improvement, implementing changes to optimize operations, and ensuring teams are performing at their highest potential to achieve organizational objectives;they often collaborate with other departments to drive company-wide success. Project/Program management: Work with leaders to d...

Perform daily, weekly, and monthly reconciliations of bank statements with internal accounting records. Investigate and resolve discrepancies in a timely and efficient manner. Record and monitor all cash transactions including bank fees, interest, and transfers. Collaborate with Accounts Payable and Accounts Receivable teams to ensure alignment of transactions. Maintain documentation and audit trails for all reconciliation activities. Prepare monthly reconciliation reports and assist with month-end and year-end closing processes. Liaise with banks to resolve any issues or discrepancies. Support internal and external audits by providing necessary reconciliation documentation. Identify opportu...

Role Overview: As the Markets Operations COO Business Execution at our company, you will be responsible for a variety of activities such as financial management, resource administration, location strategy execution, and third-party management. You will play a crucial role in supporting and facilitating our global, complex Operations organization as part of a diverse, global team. Key Responsibilities: - Manage financial expenses including permanent and non-permanent employees, travel and expense, relocation, and software. - Provide complete, timely, and accurate financial reporting to stakeholders and handle related queries effectively. - Oversee hiring and resource administration while main...

Immediate joiner - Coordinate instrument & equipment qualification and preparation of SOP. Provide application support for GxP system and software administrator. Execute user management, data backup & restoration activities administrator.

General Summary: The Procurement Coordinator is responsible for ensuring the on-time delivery of assigned materials and/or services from approved and qualified suppliers in support of aircraft manufacturing demand requirements. The primary function of the Procurement Coordinator role is to liaise with Manufacturing, Quality, Customer Service and Procurement on Supplier material delivery commitments. Resolve goods receipt issues with appropriate individuals. Manage return of non-conforming materials. Duties and Responsibilities: 1. Supports supply chain team to achieve business requirements and ensure compliance with company’s procurement policies 2. Communicates to Suppliers supply requireme...

We are seeking a dynamic and experienced Quality Control (QC) Manager to lead and manage QC operations, ensuring that products and processes meet stringent quality and regulatory requirements. The ideal candidate will possess deep technical expertise, a strong leadership background, and a commitment to data integrity and continuous improvement within the life sciences industry. A detail-oriented professional with expertise in Nitrosamines/NDSRI method development and validation by LC-MS focused on detecting and quantifying nitrosamine impurities in APIs and Finished Dosage Forms. You will contribute to method development, validation, instrument calibration, and document preparation while ens...

Summary Job Functions: Responsible for document review (Ex. Master MPCR/BPCR, QMS documents, SOP, Protocols & Reports) related to BBM, MSAT & R&D. Responsible for IPQA activities and Shop Floor Compliance in BBM Facility. Responsible for transactions required in software related to GMP activities Key Responsibilities: - Responsible for In-Process Quality Assurance activities (e.g. Area clearance, Issuance of MCB/ WCB/ EPCB Vial/ CI/ DS for batch processing, Verification of process steps as applicable and review of various processing parameters and its associated documentation related to BBM facility. - Review of new & revised documents and related transactions in respective software. (SOP, E...

Handles QC documentation, OOS/OOT review, CAPA coordination, COA preparation, audit trail review, stability monitoring, compliance verification, APQR data support, control sample approval, and LIMS-based activities. Required Candidate profile M.Sc or M.Pharm or BSc or BPharm 2-3 Years 2.5 to 3.5 LPA

Seeking a Network Administrator to manage 24/7 BPO IT infrastructure. Must ensure uptime, security, SLA compliance, and scalability. Strong English communication and experience in high-availability environments required.

You will be responsible for conducting In-Process Quality Assurance (IPQA) activities on the shop floor throughout the various stages of sterile manufacturing and packing process. This includes performing sampling at each stage or when necessary during product manufacturing, filling, and packaging activities. Your duties will also involve conducting in-process checks of manufacturing, filling, and packaging processes. You will be required to perform Acceptable Quality Level (AQL) checks after completing visual inspection of products. Additionally, you will need to carry out audit trail and electronic data reviews batch-wise and as per the designated schedule. Furthermore, you will be tasked ...

Excellent job opportunity for QA - AQA Specialist in Unison Pharmaceuticals Pvt Ltd, Moraiya, Ahmedabad About us: Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality and affordable medicines across the nation. With more than 4 decades of medical service to society, Unison is today one of the fastest-growing companies in Gujarat State. In addition to this, the company is ranked 82 among the top companies of India (Rupee wise sales) MAT March 2020. This makes Unison a distinguished company across the pharma industry. You are invited to join one of India's fastest growing pharma companies in India!! Experie...

As a Commission & Qualify professional, you will be responsible for ensuring that systems, equipment, and plants comply with pre-approved Site Acceptance Test (SAT) Protocols at the customer's site. Your primary role will involve coordinating with clients for SAT activities, creating and executing SAT plans, and resolving any site issues that may arise. Additionally, you will be expected to review site activities based on schedules, manage site costs effectively, and drive continuous improvement processes. In this role, you will play a key part in team management, including resource planning, performance appraisals, training, and grievance handling. Your expertise will be utilized in areas s...

Monthly Closing Activities Billing Process Control (SAP) Receivables Management Internal Controls & Compliance Process Improvement & Coordination * Preferred Candidates from construction or infrastructure sector * Proficiency in SAP (Billing, FICO)

Job Title: Pharma Manufacturing Process Analyst / Manufacturing Systems Specialist Job Summary: We are seeking a skilled Manufacturing Systems Analyst with strong domain expertise in pharma manufacturing processes and experience working with pharmaceutical manufacturing systems (MES, SCADA, DCS, Historian systems, etc.). The role involves review and analysis of manufacturing data, including audit trail reviews , alerts , and alarms monitoring , to support digital operations and ensure regulatory compliance. Key Responsibilities: Act as a functional SME for pharma manufacturing processes , providing process insights to support system operations and investigations. Review and analyze audit tra...

Shall have mandatorily internal auditing experience in Manufacturing company. Shall have hands on experience on SAP, ERP software Shall have prior experience in internal control, compliances, inventory management ,SOPs, risk assessments etc.

Role & responsibilities : Responsible for following activities: Handling of Change controls, Deviations, Market complaints, CAPA and other QMS Documents. Participate in investigation of Nonconformities. Participate in quality risk management and maintain its record. Preparation and review of Product Quality Review Report (APQR). To execute product recall and mock recall activities. To coordinate for management quality review meeting. Handling of internal audit activities and compliance with CAPA. Preparation and review of SOPs, SMF, Quality Manual Preferred candidate profile ERP/ QMS software system handling experience