13 Audit Trail Jobs

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 ensuring compliance with safety, regulatory, and cGLP standards. Preferred Manager profile: Design and implement robust QC procedures aligned with current Good Manufacturing Practices (cGMP) and industry standards. Ensure processes are optimized for efficiency, accuracy, and compliance. Regularly assess QC operations and procedures. Identify opportunities for improvement and implement enhancements to streamline workflow and ensure regulatory readiness. Ensure QC operations comply with global regulatory authorities including USFDA, EDQM, ANVISA, PMDA, and WHO. Maintain audit readiness and lead/support regulatory inspections. Team Leadership and Development Manage and mentor a team of QC professionals, ensuring high performance and ongoing professional development. Assign responsibilities, monitor progress, and promote a culture of accountability and collaboration. Data Integrity and Documentation Ensure accuracy, reliability, and confidentiality of all laboratory records and data. Enforce adherence to ALCOA+ principles for data integrity. Troubleshooting and CAPA Management Investigate quality-related issues, perform root cause analysis, and lead implementation of effective corrective and preventive actions (CAPAs). Cross-functional Collaboration Collaborate with AR&D, QA, and other departments to align quality strategies. Communicate quality metrics, performance, and issues to leadership and stakeholders. Quality System Contributions Support development and implementation of quality management systems (QMS). Review and approve analytical methods, validation protocols, and reports. Audit and Complaint Management Lead or support internal and external audits. Manage customer complaints and conduct trending analysis to drive quality improvements. Technical Skills: Hands-on experience and data interpretation of analytical instruments like LCMS, HPLC, GC,UV, KF, etc. Thorough understanding of cGMP, GLP, and regulatory requirements. Good documentation and analytical skills. Job Description: QC Data Review Specialist Job Summary We are seeking a meticulous and highly organized QC Data Review Specialist to join our Quality Control team. The successful candidate will be responsible for the comprehensive GMP (Good Manufacturing Practices) review of laboratory raw data, analytical reports, and related documentation. This role is critical to ensuring that all laboratory work is performed in compliance with established methods and protocols, that results are analytically sound and accurate, and that all documentation adheres to stringent GMP standards and regulatory requirements. Key Responsibilities Data and Document Review: Conduct detailed reviews of analytical data packages, including but not limited to raw data (e.g., chromatograms, spectra), laboratory notebooks, and summary reports for accuracy, completeness, and compliance with GMP. Compliance Verification : Ensure all testing was performed according to approved SOPs, analytical methods, and protocols. Verify that calculations and data transcriptions are correct and that any deviations or out-of-specification (OOS) results are properly documented, investigated, and reported. Method Validation Review : Review method validation/verification/transfer protocols and reports to ensure they meet regulatory and company standards. Stability Program Suppor t: Review stability testing data and reports, ensuring that data integrity is maintained throughout the stability study lifecycle. Audit Trail Review : Perform audit trail reviews of electronic data systems to ensure data integrity and identify any potential compliance risks. Documentation Management : Assist in the revision and approval of controlled documents such as SOPs, test methods, and specifications. Communication: Collaborate closely with laboratory analysts to resolve documentation errors, clarify discrepancies, and provide constructive feedback to prevent future issues. Act as a liaison between the QC laboratory and the Quality Assurance (QA) department. Continuous Improvement : Identify gaps in procedures and opportunities for improvement within the laboratory data review process to enhance efficiency and compliance. Qualifications Education: Bachelor of Science (B.S.) degree in Chemistry, Biology, Biochemistry, or a related life sciences field is required. Experience: A minimum of 3-8 years of hands-on experience in a GMP-regulated pharmaceutical or biotechnology laboratory environment. Direct experience in reviewing analytical data (e.g., HPLC, GC, UV-Vis, FTIR, wet chemistry) is essential. Prior experience in a dedicated data review or QA role is highly preferred. Knowledge: In-depth knowledge of GMP, GDP (Good Documentation Practices), and data integrity principles. Strong understanding of FDA, ICH, and other relevant regulatory guidelines. Familiarity with common laboratory software and electronic data systems (e.g., LIMS, Chromeleon, Empower). Required Skills and Competencies Attention to Detail: Exceptional ability to spot errors, inconsistencies, and deviations in complex technical documents. Analytical and Critical Thinking: Strong ability to interpret scientific data and assess its validity and compliance. Organizational Skills: Excellent time management skills with the ability to manage multiple review assignments and meet deadlines. Communication Skills: Clear and effective written and verbal communication skills are necessary to articulate findings and collaborate with team members. Problem-Solving: Proactive in identifying issues and working with the team to find compliant solutions. Integrity: Must uphold the highest standards of quality and ethical behavior. Teamwork: Ability to work effectively both independently and as part of a collaborative team. Behavioral & Leadership Skills: Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities. Demonstrated ability to lead cross-functional teams and drive a culture of quality. Why JanSat? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As JanSat focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness.

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, EBMR, BPCR, MPCR, TTD, PTN, Protocol, Report and QMS documents of BBM, MSAT and R&D). - Review of Change Controls, CAPA, Deviations, OOT, OOS and related transactions in respective software. - Preparation and Review of APQR related to CI and DS. - Responsible for Handling and review/assessment of FMS Alarm, Equipment Breakdown, SAP Incident and ERN (Error Ratification Notification) Handling. - Responsible for approval of material request from various user departments related to BBM facility. Responsible for approval/authorization of user access request related to BBM facility. - Review of Electronic record and Audit trail related to equipment/systems of BBM Facility. - Responsible for verification of BOM in SAP. Responsible for doing transactions related to BPCR review and Interim batch release in SAP. Responsible for QMS notification creation in respective software. - Responsible for EBMR/ E-Logbook Data creation, modification In SAP. Responsible for linking BOM with the effective MPCR in case of EBMR in SAP. - Monitoring and participation in Process Validation/Cleaning Validation activities of BBM. Review and compilation of Process Validation/Cleaning Validation documentation. - Participation in internal/external audits. - Preparation and review of the documents related to the quality assurance - Responsible for providing required document support to RA, R&D and DQA. - To follow Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site.

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 with managing control samples and stability samples. Your role will also include participating in the qualification of master kit approval for visual inspection activities. You will be expected to review and approve all relevant documents related to the qualification of visual inspectors. Overall, your attention to detail and adherence to quality standards will be crucial in ensuring the production of high-quality sterile products.,

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!! Experience: 4-9 Years Location: Moraiya Designation: Officer/Sr. Officer / Executive Section : Analytical QA (Lab QA) Must have: Candidate should have working exposure of OSD facility Job profile (Not limited to): To review analytical documents i.e. worksheet, specification, method of analysis, stability protocol & summary report and logbook etc. of Quality Control department. To participate in investigation and reporting of lab incident, OOS/OOT and any other quality related issues. To co-ordinate with other departments for QC related activities and review of data entry. Perks & Benefits Dynamic work environment Career development opportunities Work-life balance Free transportation Canteen Facility Free insurance coverage for self, spouse, and kids Range of learning opportunities to help employees grow and thrive If you are passionate about continuing to work in the pharmaceutical industry and possess the required skills, we encourage you to apply for this position. Please submit your resume to career@unisonpharmaceuticals.com to be considered for this role. Join our team at Unison Pharmaceuticals and take the first step towards a rewarding career!!! Regards Team HR Unison Pharmaceuticals Pvt. Ltd.

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 such as Commissioning, Site Piping, Installation & Qualification, Validation Protocols (SAT, IQ/OQ), Process Validation, and Equipment Validation. You will also be involved in risk management, compliance testing, functional and performance testing, as well as documentation and change control processes. Your responsibilities will extend to ensuring regulatory compliance with bodies such as FDA, EMA, and adherence to industry standards like ASME BPE Code, EU Guidelines for C&Q, and other relevant regulations. You will be involved in the 4 Stages of Equipment Qualification, CSV of System, Audit Trail, CIP/SIP, and Sterile Industry/Formulation practices. As part of your daily tasks, you will be carrying out Installation & Qualification, Equipment Qualification, Process Validation, OQ & CSV (Computer System Validation). You will also be involved in preparing Change Control Management, NCR (Non-Conformance Report), Documentation & Reporting, and Site Schedule (IQ & OQ). To excel in this role, you should have a Graduation/Post Graduation degree in Engineering, Biotechnology, or Chemical with 4 to 6 years of relevant experience. Your ability to coordinate effectively, manage site activities, and ensure compliance with regulatory requirements will be crucial for success in this position.,

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 trail data generated from manufacturing systems to ensure data integrity and compliance with ALCOA+ principles. Perform periodic review of alerts , alarms , and exception logs as part of routine monitoring and deviation investigations. Collaborate with production, QA, and IT teams for resolution of issues related to manufacturing systems. Support the digitization and continuous improvement initiatives in manufacturing areas. Participate in system validations, including URS development, system configuration reviews, and functional testing. Prepare and maintain SOPs and system documentation related to manufacturing systems usage and monitoring. Train end-users on manufacturing systems functionalities and regulatory requirements. Required Skills and Qualifications: Strong understanding of pharma manufacturing processes (Batch Processing, Equipment Usage, Environmental Monitoring, etc.). Hands-on experience working with Pharma Manufacturing Systems (MES, DCS, SCADA, Historian platforms). Good knowledge of audit trail review and interpretation of manufacturing system logs. Understanding of alerts , alarms , and deviation data as part of electronic record review. Familiarity with data integrity guidelines (21 CFR Part 11, EU Annex 11, WHO TRS). Experience in handling system compliance documentation (SOPs, URS, validation reports). Ability to collaborate effectively with QA, Manufacturing, and IT stakeholders. Preferred Qualifications: Knowledge of GAMP 5 , CSV principles, and pharma regulatory requirements. Experience in data review from systems like Siemens Simatic, Emerson DeltaV, Rockwell Automation, PAS-X, or similar MES/DCS platforms . Exposure to Industry 4.0 and digital transformation initiatives in manufacturing.

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

oversees and executes audits within a manufacturing environment, focusing on commercial & operational processes teams, plan and conduct audits, analyze findings & provide recommendations for improvement, ensuring compliance & operational efficiency.

Shall have mandatorily internal auditing experience in Manufacturing company. Shall have hands on experience on Navision, Microsoft D 365 Shall have prior experience in internal control, compliances, inventory management ,SOPs, risk assessments etc.