Site Investigation Lead, Quality Assurance

Software Engineer, Quality Analyst

Senior software engineer QA

Responsibilities: Investigation Management <ul><li>Timely review and support to closing of OOS/OOT/Deviations/Market complaints/Customer notifications as an investigational SME Role.</li><li>Review and ensure identified Root cause/Hypothesis is based on sound scientific Rationale and evidence.</li><li>Review and ensure Investigation order is proper and logical.</li><li>Review and ensure Investigation articulation is proper and not Misleading /Ambiguous.</li><li>Review and ensure Identification of CAPA’s is consistent with investigation findings</li><li>Provide appropriate rating to Root cause investigation based on Hypothesis, Investigation order, Investigation articulation and Identification of CAPA’s.</li><li>Undertake continuous trainings and developments from an outcome of Investigations and CAPA’s.</li><li>Implementation of best practices in Investigation review mechanism, policies, processes and procedures to aid and improve operational performance and Quality Metrics.</li><li>Support to Implement all relevant procedures described in the Quality Management System (QMS) like Deviation, RCI, Complaint management etc.,</li><li>Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.</li><li>Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.</li><li>Review and identify areas of improvement in the investigations.</li><li>Ensure the compliance with current industrial practices and constantly meet the regulatory requirement with zero integrity issue.</li></ul> Workload Management&nbsp; <ul><li>Coordinate workload sharing with Investigators team and develop action plans to improve timeline and quality of investigations</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li></ul> Staff Development	 <ul><li>Evaluate potential candidates for Investigation team, performance evaluation of direct reports.</li></ul> Requirements: Education &amp; Experience&nbsp; <ul><li>Bachelor’s degree in pharmacy, Chemistry, Biotechnology, or related scientific discipline (master’s preferred)</li><li>10+ years of experience in pharmaceutical manufacturing, quality, or compliance roles, including investigation management</li><li>Prior experience leading teams and conducting root cause analysis for deviations, OOS/OOT, and quality events</li><li>Working knowledge of FDA, EU, and other global regulatory requirements Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>In-depth understanding of cGMP regulations, 21 CFR Part 211, ICH Q9/Q10 principles</li><li>Strong knowledge of manufacturing and QC processes for solid oral dosage forms, non-sterile liquids and semi-solid dosage forms</li><li>Familiarity with investigation tools and techniques (e.g., 5 Whys, Fishbone, FMEA)</li><li>Experience with Quality Management Systems (e.g., TrackWise, MasterControl)</li><li>Skills &amp; Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li><li>Excellent analytical thinking and problem-solving skills</li><li>Excellent critical thinking and root cause analysis skills</li><li>Ability to work cross-functionally and influence without authority</li><li>Proven ability to meet deadlines while handling multiple investigations</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Ability to work on-site full-time in both office and GMP environments</li><li>Sit or stand for extended periods; walk between manufacturing and laboratory areas</li><li>Ability to occasionally lift or move materials up to 25 pounds</li><li>Use of personal protective equipment (PPE) as required Investigation Management</li></ul>

Responsibilities: <ul><li>Understand the test requirements and getting the team aligned with the same.&nbsp;</li><li>Participating on all technical aspects, interacting with client for all technical inputs and queries.&nbsp;</li><li>Automation and integration of complex processes.&nbsp;</li><li>Work closely with the development team on becoming the SME of the product.&nbsp;</li><li>Strong Testing Fundamentals , testing tools, reporting and frameworks.&nbsp;</li><li>Build and maintain the automation regression suite for the white box testing of the products.&nbsp;</li><li>Participate in requirement grooming and think form end customer perspective.&nbsp;</li><li>Should own all aspects of Testing, QA Framework for existing Products and Product end-to-end testing across functional, Security and Automation.&nbsp;</li><li>Work in a dynamic Agile environment and come up with solutions to meet project needs.&nbsp;</li><li>Communicate with Client and end customers in written and verbal.&nbsp;</li><li>Should be able to interact with client and customers for Escalated Customer Issues/Bugs.&nbsp;</li></ul> ﻿Requirements: <ul><li>Manual/Automation Testing - DataCom (Networking , Security, L2-L3, L4-L7 Protocols)&nbsp;</li><li>Hands on experience on Networking products Switch Router and Firewall&nbsp;</li><li>Good testing experience in Datacom/IP-Networking/Switching/routing domain.&nbsp;</li><li>Knowledge of Networking (L2/L3 protocols)&nbsp;</li><li>Knowledge of Testing tools : IXIA/SPIRENT&nbsp;</li><li>Security testing tool - Nessus, OpenVas, Achilles, Defensics (Anyone)&nbsp;</li><li>preferably knowledge / hands on in traffic generation tools such as IXIA or Spirent,&nbsp;</li><li>Performance and scalability testing, security, Penetration testing. packet sniffing tools.&nbsp;</li><li>Linux/containers Knowledge&nbsp;</li><li>Good understanding of testing concepts and hands-on experience in functional/sanity/regression testing.&nbsp;</li><li>CI/CD: Jenkins, GitHub, Bitbucket Actions&nbsp;</li><li>Scripting: Python and/or Shell is a must&nbsp;</li><li>Working experience in Routing protocols such as RIP, OSPF, BGP, MPLS VRRP&nbsp;</li><li>Good understanding of Management interface such as SNMP, Web, Yang, Netconf, Rest based interfaces etc&nbsp;</li><li>Good understanding of testing concepts and hands-on experience in functional/sanity/regression testing.</li><li>Strong written and oral communication skills.&nbsp;</li><li>High levels of motivation with a can-do attitude.&nbsp;</li></ul>

Job Summary: <ul><li>As a Senior Software Engineer-QA,candidate will be individual contributor in Manual/Automation QA team and also do hand on in writing, Execution the Manual and automation test cases using Test tools and Python Good knowledge of product security and relevant testing.&nbsp;</li><li>This position reports directly to the QA Manager and will work from our Pune office.</li></ul> Responsibilities: <ul><li>Understand the test requirements and getting the team aligned with the same.</li><li>Participating on all technical aspects, interacting with client for all technical inputs and queries.&nbsp;</li><li>Automation and integration of complex processes.</li><li>Work closely with the development team on becoming the SME of the product.</li><li>Strong Testing Fundamentals knowledge, testing tools, reporting and frameworks.</li><li>Build and maintain the automation regression suite for the white box testing of the products.</li><li>Participate in requirement grooming and think form end customer perspective.</li><li>Should own all aspects of Testing, QA Framework for existing Products and Product end-to-end testing across functional, Security and Automation.&nbsp;</li><li>Work in a dynamic Agile environment and come up with solutions to meet project needs.&nbsp;</li><li>Communicate with Client and end customers in written and verbal.&nbsp;</li><li>Should be able to interact with client and customers for Escalated Customer Issues/Bugs.&nbsp;</li><li>Strong written and oral communication skills.</li><li>High levels of motivation with a can-do attitude.</li></ul> Requirements:&nbsp; <ul><li>Manual/Automation Testing - DataCom (Networking , Security, L2-L3, L4-L7 Protocols)</li><li>Hands on experience on Networking products Switch Router and Firewall</li><li>Good testing experience in Datacom/IP-Networking/Switching/routing domain.</li><li>Knowledge of Testing tools : IXIA/SPIRENT</li><li>Security testing tool - Nessus, OpenVas, Achilles, Defensics (Any one)</li><li>preferably knowledge / hands on in traffic generation tools such as IXIA or Spirent,</li><li>Performance and scalability testing, security, Penetration testing. packet sniffing tools ,</li><li>Linux/containers Knowledge&nbsp;</li><li>Good understanding of testing concepts and hands-on experience in functional/sanity/regression testing.</li><li>CI/CD: Jenkins , Github, Bitbucket Actions</li><li>Scripting: Python and/or Shell is a must&nbsp;</li><li>Working experience in Routing protocols such as RIP, OSPF, BGP, MPLS,VRRP</li><li>Good understanding of Management interface such as SNMP, Web, Yang, Netconf, Rest based interfaces etc</li><li>Good understanding of testing concepts and hands-on experience in functional/sanity/regression testing.</li></ul>

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Site Investigation Lead, Quality Assurance

Software Engineer, Quality Analyst

Senior software engineer QA

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3 sme Jobs found

Site Investigation Lead, Quality Assurance

Software Engineer, Quality Analyst

Senior software engineer QA

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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