433 Capa Jobs - Page 13

? Do Conduct process quality audits as per plan Conduct various process audits (1 audit/ agent/ week) as per procedure and guidelines For agents identified in the bottom quartile of performance, conduct 3 audits/ agent/ week Prepare findings from the report and share it with the client and the account leadership on daily/ weekly/ monthly, as required Conduct weekly analysis to identify the error trends and for top 2 errors, conduct root cause analysis (RCA) Conduct calibration communication to communicate any changes from the client and conduct refresher trainings to bridge any skill gap due to these changes.

? Do 1. Conduct process quality audits as per plan Conduct various process audits as per guidelines and SPO’s defined in QMS Prepare findings from the report and share it with the account/ project leadership on daily/ weekly/ monthly, as required Conduct weekly analysis to identify the error trends and for top 2 errors, conduct root cause analysis (RCA) Conduct calibration communication to communicate any changes from the client and conduct refresher trainings to bridge any skill gap due to these changes 2. Conduct analysis, report generation and process compliance in different areas like metrics office, CAG, Process Definition Ensure processes to be followed in Wipro in terms of all quality norms in the areas of project management and highlight potential risks Provide insights and process guidance to the projects as per the need Prepare timely dashboards, reports, insights and share with the central quality and delivery teams to ensure minimum client escalation From time to time highlight any critical escalations where the central quality team’s intervention is required in any BU project team Automate the report generations etc to ensure minimization of non-value added tasks, ensuring maximum utilization of existing platforms and their increased adoption

Develop implement/maintain QMS specific to Electrical Construction Proj. Ensure all construction activities comply with Industry standards, safety regulations & proj. specs Inspection audit/quality checks at multiple stages to identify/address issues Required Candidate profile BE/B Tech in Electrical 7 to 12 Exp. Electrical Construction/Projects Strong knowledge of industry standards, codes & regulations related to Eect. construction Certified in ISO 9001,TMP/TQM Can mentor Perks and benefits Corporate Office Health & wellness benefits PMS

Role & responsibilities Quality Assurance and Inspections: Ensure the overall quality of Returnable Packaging Kits (RPK) and their sub-items supplied to customers. Inspect and validate the quality of RPK kits and sub-items manufactured or received from vendors. Conduct quality inspections of repaired or reworked RPK kits and sub-items at vendor or in-house facilities. Perform incoming quality checks of new components like pallets, poly boxes, PP partitions, etc. Conduct final quality inspections for bulk-manufactured RPK kits and proto samples. Inspect RPK kits at customer or Tier-1 premises to ensure they meet specified standards. Monitor the shelf life and completed usage cycles of RPK kits and initiate preventive maintenance as needed. Repair and Maintenance Coordination: Facilitate repairs and reworks for damaged RPK items (wooden pallets, poly boxes, etc.) by coordinating with vendors or in-house teams. Supervise and lead a team of fabricators, welders, and machinists. Organize preventive maintenance activities for RPK kits in the pool to avoid failures. Communicate with internal teams to assess repair requirements, arrange necessary parts, and manage procurement requisitions. Documentation and Reporting: Maintain detailed records of inspection reports, repair logs, and quality checks in compliance with ISO standards. Track repair and maintenance activities in spreadsheets and ensure proper documentation. Provide feedback to vendors and internal teams on quality improvement opportunities. Process Improvement and Damage Prevention: Suggest and implement strategies to minimize damages and extend the lifecycle of RPK kits. Collaborate with design, production, and procurement teams to enhance the quality of packaging materials. Team Coordination: Lead and guide a team of supervisors, ensuring effective execution of quality control tasks. Train and mentor team members on quality standards, inspection techniques, and preventive measures. Preferred candidate profile Qualifications: Diploma/Degree in Mechanical Engineering, Manufacturing, or a related field. 5+ years of experience in fabrication, including at least 2 years in a leadership role. Strong knowledge of fabrication techniques (e.g., welding, cutting, bending, machining). Perks and benefits Best In the Industry

Regulars Basis

Job Objective - Lead the planning, coordination & staffing within the department and coordinate with other interfacing functions to achieve the budgeted Postproduction and Despatch targets with desired quality standards on a fortnightly basis. Roles and Responsibilities - Monitor and review efficiency of Post Production-Manufacturing Operations (ATS , Printing , Camera ,Packing) in order to achieve AFOE@Despatch Review resource planning (Man and Material) to ensure Line continuity Review and ensure implementation of continuous improvement actions in order to enhance PQDSM Monitor and review CAPA implementation in order to avoid repeat customer complaint in coordination with Quality Monitor and implement Systems for First time right Product quality at all stages of the Section Ensure for 100 % Online Batch completion within 48 hours Ensure SAP entries compliance to ensure zero non-conformities Interface with Support functions and Quality to ensure Packing compliance as per Customer requirements Monitor and review Maintenance planning and effectiveness in order to ensure Line continuity and minimum Process loss Monitor and review cGXP (GMP,GDP) practices in order to follow regulatory compliances Monitor and review Material, Manpower in order to achieve Cost optimization Ensure zero non-compliances in Internal and External audits for Business continuity Ensure adherence to safety guidelines/ Environment Management System - ISO14001-2015 / Occupational Health and Safety - ISO45001-2018, c-GMP, regulatory & statutory compliances, TPM and other applicable norms. Ensure legal compliance as per Factories Act 1948. Review root cause of accident and environmental incidence and able to implement corrective/prevention action to avoid recurrence. Batch completion compliance. Capacity enhancement and planning- bottleneck identification and elimination. Internal Process - Preparation and review of process loss, performance reports of section. Preparation of Digitalization project status reports Preparation of presentations required for review meetings Preparation and control of Final budget for the year and get it approved Preparation of manpower requirement planning for section Preparation of Job description and charter of demand and approval from concerned Goal setting, performance appraisals of all associates from department. Raising requirements for new equipments with proposals with justifications Customer complaint CAPA preparation and implementation of same on machines. Controlling cost000 capsules and implementing actions for control. CTQ audit review and ensure effectiveness. CI initiatives- Six sigma and lean projects review and follow up.

Roles and Responsibilities (Hiring for AQA Role, IPQA Role, QMS Role - API Background is Must) Ensure compliance with GMP, BMR, BPR, SOPs, and quality systems. To Perform Analytical QA Role IPQA Activities QMS Activities Validation Activities Collaborate with cross-functional teams to ensure timely completion tasks Person Should be from the API Background

We have an urgent opening with our esteemed client. Our client Since 1963, have been offering tailor-made, cutting-edge metal packaging solutions for diverse customers across the globe while generating a balance among economic growth, environmental preservation, and social responsibility. Experience : Min 2-3 years+ experience in Quality Management System in a manufacturing setting (Knowledge of ISO Quality Management System) Location : Chakan (Pune) Roles & Responsibilities: Implementation of ISO 9001:2015 Standards Document Control (ISO related QMS documentation) Participate in root cause analysis for quality issues and recommend corrective and preventive actions (CAPA). Support the development of training materials and conduct sessions to create awareness about ISO standards and QMS among employees Ensure that all departments comply with QMS requirements and work toward continual improvement. Generate monthly quality performance reports and identify trends for management review. Monitor customer satisfaction metrics as part of the QMS. Document and manage any changes in processes or standards affecting QMS Regards, Shakil

Description Customer Care-----Call center Operations Specialist-One to Three Years,Frontend Helpdesk-One to Three Years Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade A Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility No Global Role Family To be defined Local Role Name To be defined Local Skills help desk;call center Languages RequiredENGLISH Role Rarity To Be Defined

Description Customer Care-----Call center Operations Specialist-One to Three Years,Frontend Helpdesk-One to Three Years Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade A Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility No Global Role Family To be defined Local Role Name To be defined Local Skills help desk;call center Languages RequiredENGLISH Role Rarity To Be Defined

Description Customer Care-----Call center Operations Specialist-One to Three Years,Frontend Helpdesk-One to Three Years Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade A Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility No Global Role Family To be defined Local Role Name To be defined Local Skills help desk;call center Languages RequiredENGLISH Role Rarity To Be Defined

Description Customer Care-----Call center Operations Specialist-One to Three Years,Frontend Helpdesk-One to Three Years Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade A Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility No Global Role Family To be defined Local Role Name To be defined Local Skills help desk;call center Languages RequiredENGLISH Role Rarity To Be Defined

Description Customer Care-----Call center Operations Specialist-One to Three Years,Frontend Helpdesk-One to Three Years Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade A Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility No Global Role Family To be defined Local Role Name To be defined Local Skills help desk;call center Languages RequiredENGLISH Role Rarity To Be Defined

Description Customer Care-----Call center Operations Specialist-One to Three Years,Frontend Helpdesk-One to Three Years Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade A Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility No Global Role Family To be defined Local Role Name To be defined Local Skills help desk;call center Languages RequiredENGLISH Role Rarity To Be Defined

CSV Overall, 10 + Yrs. of experience in SAP CSV Validation Services. Developing validation strategies and plans for SAP implementations, upgrades, and modifications to ensure compliance with regulatory requirements. Conducting System GMP impact assessment, GAMP category assessment, ERES applicability assessment, Requirement/ Functional risk assessment after establishing communication with relevant stakeholders. Conducting change assessments and impact analyses to identify mandatory validation deliverables. Collaborating with cross functional teams, including IT, Business Process, CSV and Quality Assurance to ensure alignment on validation deliverables. Creation, execution, documentation, and review of validation plan, including FDS, BDS, TDS, test plan/ scripts, IQ/OQ/PQ Protocols, Traceability Matrix, validation reports and Release notification (Go Live). Support in defect management/ discrepancy investigation if any as part of the validation deliverables. Providing guidance and support to project teams on validation best practices and compliance requirements. Submit the complete Change/Incident/Project documentation with evidences for review and approvals by the business/quality teams. Upon acquiring all approvals, shall communicate to the development/transport/Basis teams to deploy the change/incident/project in Production environment. Ensure the change/incident/project in Production environment is deployed without any deviations. Participating in validation related meetings, training sessions. Participate in Governance reviews, status reporting and handling of escalations Keeping abreast of industry trends, regulatory changes, and best practices related to CSV in SAP. Contributing to the continuous improvement of validation processes and procedures within the organization. Support during Client Visit and Regulatory inspections.

A Clean Shaven Personnel having a experience of Not Less than 2 and NMT 3 Years in Sterile Facility -Experience of having worked in the Sterile Area -Execution of AHU, Autoclave and DHS Validation -Temperature Monitoring Execution -Review of BMR/BPR before final Submission -Knowledge of Dry Powder, Ampoule Section and the Asceptic Practices

The ideal candidate will ensure that all products meet industry standards and comply with regulatory requirements Develop and maintain procedures to comply with external regulations (ISO, GMP, FDA) Lead audits and inspections for regulatory bodies Required Candidate profile Knowledge about ICH, USFDA, WHO , PMDA Japan, EDQM, guidelines. Technical knowledge on data review for FG, BMR, Stability Data, RM, Method validation Change control, CAPA, Incidents, OOS, OOT.

Quality assessments on all incoming materials from vendors and outgoing products shipping. Reject all product materials that fail meet quality expectations. Read blueprints, plans, and specifications to understand requirements products and services.

Set up approval &In process inspection as per control plan. KPI target. Layout inspectionof Casting as per development plan TPM',"5S"or"SAFETY WEEK"etc. Kaizens Closure-non conformingoccurs, CAPA, Process Audit, Product Audit, CFTNPD,QSR, lab testing Required Candidate profile Give NC,Instrument,gauges handling.skills of subordinate,prepare training need,CFT for new product development.ensure availibility of required drawing/gauge/instrument/customer standard/SOP,SPC/MSAQSR

We have been retained by a highly reputed and fast growing Pharma Company to hire "Senior Manager- QA" to be based at their plant located at Aurangabad. Details of the position are mentioned below: Company: Our client is a highly reputed and fast growing Pharma Company. Company's products enjoy a very high degree of acceptance from doctors within India as well abroad. The company has their manufacturing units spread across different locations in India. The sales turnover of the company is more than 700 Crores. Designation: Senior Manager - Quality Assurance (Formulation Unit manufacturing Oral Solid, Liquid Oral & Sterile Injectables) Educational Qualification: M.Sc. / M. Pharma Experience: Minimum of 10 to 15 years of experience of handling QA function of a reputed Pharma Company. Besides QA, the candidate must have basic understanding of QC function also. The incumbent shall have the experience of working as Deputy Manager / Manager QA or above level in a reputed Pharma Company for at least 3 years Job location: Aurangabad Those of you whose profile matches the above mentioned description and will like to apply for this position shall forward their updated profile to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak Director, Pharma Placements Inc. Mobile: 98202 34987 / 81307 24980

Job Title: Manager/Senior Manager QA Regulatory Affairs Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 8-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: M.Sc in Biotechnology, Microbiology, or a related field Bachelor’s or Master’s in Pharmacy Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager/Senior 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 (QA) standards. You will oversee regulatory strategies, regulatory audits, and the management of Quality Management Systems (QMS) to ensure our products comply with industry-specific standards. This role demands extensive experience in regulatory affairs , particularly within the vaccine and sterile manufacturing domains, including handling CDSCO , EU GMP audits, and other regulatory matters. Key Responsibilities: Regulatory Strategy & Compliance: Develop and execute regulatory strategies to ensure compliance with global standards for vaccine , injectable , and sterile products . Maintain a strong understanding of global regulatory requirements, including FDA , EMA , WHO , and local regulations like CDSCO to guide product approvals and market entry. Ensure alignment of product development and manufacturing processes with Good Manufacturing Practices (GMP) , Good Laboratory Practices (GLP) , and other relevant GxP standards. Audit & Inspection Management: Coordinate and manage regulatory audits (e.g., CDSCO , EU GMP ) for vaccine , injectable , and sterile products, ensuring full compliance and readiness across all departments. Lead the preparation for regulatory inspections related to CDSCO and EU GMP , working closely with relevant teams to ensure effective corrective actions and continuous compliance. Manage responses to audit findings and ensure the implementation of corrective actions in line with industry standards. Quality Management System (QMS): Oversee the implementation and management of the Quality Management System (QMS) to ensure product quality and regulatory compliance. Lead the development and review of Standard Operating Procedures (SOPs) , ensuring that they align with current regulatory requirements for vaccine and sterile product manufacturing. Monitor and ensure compliance with the QMS framework across all departments to maintain consistent product quality. Regulatory Submissions & Documentation: Oversee the preparation, compilation, and submission of regulatory dossiers and eCTD documents to regulatory bodies (e.g., FDA , EMA , CDSCO ). Ensure that all required documentation and records are properly maintained and comply with regulatory standards, ensuring smooth regulatory approvals for vaccine , injectable , and sterile products . Risk Assessment & Mitigation: Conduct regulatory risk assessments to identify potential issues related to product development, manufacturing, and compliance. Develop and implement risk mitigation strategies to ensure uninterrupted production and compliance with regulatory standards. Cross-Functional Collaboration: Collaborate with internal teams such as R&D, Production, and Quality Control to ensure regulatory compliance throughout the product lifecycle, from development to post-market surveillance. Provide regulatory guidance and training to cross-functional teams, ensuring awareness of applicable QA practices and regulatory requirements . Corrective and Preventive Actions (CAPA): Lead the implementation of Corrective and Preventive Actions (CAPA) to address audit findings, non-conformities, and deviations, ensuring continuous improvement in compliance and quality practices. Key Skills and Competencies: Expert Knowledge of Regulatory Guidelines : Extensive knowledge of global regulatory requirements (e.g., FDA , EMA , WHO ) with specific expertise in vaccines , injectables , and sterile product manufacturing . Regulatory Submissions & Documentation Expertise : Strong experience in preparing regulatory dossiers and eCTD submissions in compliance with regulatory standards for vaccines and sterile products . Audit & Inspection Management : Hands-on experience managing CDSCO and EU GMP audits, including preparing for inspections, addressing findings, and implementing corrective actions. Quality Management System (QMS) Oversight : Expertise in implementing and maintaining QMS in compliance with GxP , FDA , EU , and WHO guidelines, ensuring product quality and regulatory compliance. Risk Management & Mitigation : Proven ability to conduct regulatory risk assessments and implement mitigation strategies to prevent non-compliance and product issues. Strong Leadership & Project Management : Demonstrated ability to lead cross-functional teams, manage multiple projects, and meet regulatory deadlines while ensuring alignment with quality and regulatory expectations. Corrective & Preventive Action (CAPA) Implementation : Experience in managing CAPA processes, addressing non-compliance issues, and ensuring the effective resolution of audit findings and regulatory observations. Excellent Communication Skills : Strong verbal and written communication skills, with the ability to liaise with internal teams, regulatory bodies, and external stakeholders in a professional and clear manner. About GreenSignal Bio Pharma Pvt Ltd: GreenSignal Bio Pharma Pvt Ltd is a leading pharmaceutical company specializing in vaccine , injectable , and sterile products . Our commitment to quality, compliance, and innovation has made us a trusted partner in the healthcare industry. We are looking for experienced professionals to contribute to advancing our vaccine and biologics portfolio while adhering to the highest regulatory standards. For more information, please visit: www.gsbpl.com How to Apply: Interested candidates can apply via email at: hr@gsbpl.com For inquiries, please contact us at: +91 8778926365 Join Our Team and make a significant impact in the vaccine and sterile product industries

Implement QMS standards as per AS9100. Responsible for Preparation of Quality documents. Use and maintain quality instruments and update their calibration. Interact with customer about various quality requirements. Generate RCCA and implement CAPA

Overview Job Overview: This position is responsible for planning the Schedule maintenance programs and processes for the site to minimize impact on production. Position will be responsible for planning maintenance work orders, place maintenance parts order, maintain maintenance budget and work with Operations & other key teams to develop the plans to minimize the interruptions to facility. Position will be responsible ensuring the health of CMMS. Position is responsible to circulate reliability related key reports for the site. Responsibilities Responsibilities: Maintenance Planning Prioritization of Maintenance Jobs based on Criticality in terms of Food Safety, quality and Human Safety and deliver TAT defined with the operation team Resource Planning as per the prioritization matrix Align Cross functions on Weekly & Monthly for Reactive and Preventive Maintenance Plans and to ensure minimum disruption to the production plans Release Weekly Maintenance Plan for Both Utilities, Process Areas and other facilities Allocate Manpower (Internal) to Weekly plans Plan external resources 3rd Party Support, Spares and consumables to complete Maintenance Plans Create PRs as per requirement & coordinate with Procurement for timely release of POs & delivery of supplies. Track & Release bi-weekly report on Pending PR/PO status through coordination with Procurement function Upkeep the Equipment history cards and job orders database Plant & keep upgrading the spares inventories in engineering stores in line to A/B/C category of machines. Managing Maintenance on CMMS Coordinate between Project Manager to Update Asset Register on CMMS Ensure proper closure of job request post successful completion & handover of equipment Through cross functional collaboration ensure logging of - CAPA, Audit Findings, Breakdowns, Improvement points in CMMS Release weekly reports on - Pending jobs from CMMS Release weekly & Monthly reports on PM schedule compliance Release MTTR & MTBF on Bi-Weekly Basis AOP Management Track spends as per phasing & individual GL codes Do analysis of spends w.r.t. AOP guidelines & release COC for under/overspends with complete COC. Release COCs and provide the provisions to Finance with the help of Reliability Manager at the end of each month Support Engineering Manager on AOP process with Zero base Budgeting Release monthly reports on Spending on different heads and PR- PO Process Release the PTR reports for actions taken in reliability function on monthly basis. Assists the Engineering Manager in periodic analysis of cost trends with recommendations for continual improvement. Ensure the compliance of financial reporting and financial controls Must comply to all EHS norms & policies as per PepsiCo guidelines. Demonstrate compliance to Code of Conduct and PepsiCo Values Qualifications: The applicant should be a Graduate in Engineering with minimum 1-2 years of experience in handling the Maintenance Planning role.

Job Summary: We are looking for an experienced Field Failure Quality Sr. Manager to lead the investigation, resolution, and prevention of product failures in the Electric Vehicle (EV) automotive sector. This role will be responsible for analyzing field data, collaborating with engineering and manufacturing teams, and implementing corrective actions to improve product reliability and customer satisfaction. The ideal candidate will have expertise in EV powertrains, battery systems, charging infrastructure, and vehicle diagnostics , along with strong problem-solving and quality management skills. Key Responsibilities: Field Failure Analysis & Resolution Investigate customer-reported failures, warranty claims, and quality issues in EV powertrains, batteries, charging systems, and electronic components . Identify root causes using structured problem-solving tools ( 8D, DMAIC, Ishikawa, 5-Why ). Collaborate with service centers, fleet operators, and charging networks to gather real-world failure data. Develop and implement corrective and preventive actions (CAPA) to eliminate recurring failures. Cross-Functional Collaboration Work closely with engineering, manufacturing, supplier quality, and R&D teams to resolve field failures. Escalate critical quality issues and drive rapid containment actions. Provide technical support and training to customer service, dealership, and warranty teams . Interface with OEMs, Tier 1 suppliers, and regulatory bodies to ensure compliance with quality standards. Data Analysis & Reporting Track and analyze warranty claims, failure rates, battery degradation data, and field return trends . Develop dashboards and reports to monitor key quality metrics. Present findings and recommendations to senior management and key stakeholders. Continuous Improvement & Quality Assurance Drive proactive quality improvements in EV design, materials, and manufacturing processes. Implement robust validation testing for EV components to improve durability and reliability. Lead customer feedback loops to enhance battery life cycle management, charging performance, and thermal management . Qualifications & Experience: Education: Bachelors degree in Engineering ( Electrical, Mechanical, Automotive, or related field ). Experience: 10+ years in automotive quality management, field failure analysis, or warranty management . Expertise in EV systems, battery technology, high-voltage components, and vehicle diagnostics . Strong knowledge of automotive quality standards (IATF 16949, ISO 9001, APQP, PPAP, FMEA) . Hands-on experience with EV diagnostic tools, CAN bus analysis, and predictive failure analytics . Strong analytical skills and experience in data-driven decision-making . Excellent communication, problem-solving, and leadership abilities. Preferred Skills: Experience with EV battery degradation analysis, BMS (Battery Management Systems), and thermal management . Knowledge of charging infrastructure standards Ability to work in a fast-paced, customer-focused environment . Why Join Us? Work on cutting-edge EV technology and next-generation quality initiatives . Opportunity to make a direct impact on EV reliability and customer experience . Competitive salary, benefits, and career growth opportunities in the EV industry . Collaborative work culture with cross-functional innovation.

Role & responsibilities Preferred candidate profile 1. Responsible for the Change control Handling through Track wise related to Spec & STP & CAPA 2. Prepare the Specification & Standard testing procedure of API Site. 3. Review of Method of analysis (MOA), Specification, STP of RM, IM, PM, INP, API & Cleaning generated by R&D Analytical. 4. Review of Standard qualification COA. 5. Review of Method comparison & MOA with Pre-validation data 6. Review of Validation Protocol & validation Report with respect to analytical data and Journal. 7. Review of R&D batches Stability data. 8. Issuance, login and closing of Incidence and change control of DQA/R&D-synthesis/R&D-Analytical. 9. Issuance of format, Logbooks, BMR and uncontrolled copy of MOA and/or Spec & STP. 10. Document and data control i.e. Receiving, Issuance/Distribution, Archival, Control, Storage and destruction of documents. 11. Assigning analytical method validation protocol and Report Numbering. 12. Responsible for sample management activity (i.e. Receiving, Issuance and Discard)