Good morning. Client is looking to have interviews happening over the weekend for these positions if possible. These are all open and urgent. You can send resumes. Let me know if you have any questions.
*Requirement 1* *Validation Engineer – Sailpoint – Foster City, CA* 1) 6 – 10 years of CSV experience. 2) Must be strong in validation, typically having lead validation teams for identity and access management software implementations. 3) Experience in validating SailPoint application (Identity and Access Management software) is highly desired. If no candidates with this experience is available, any other identity and access management software is ok. 4) Excellent in communication and documentation skills. Look for Sailpoint experience ideally with Pharma or Lifesciences. Must be good in documentation. Key words: 21cfr11, Identity and Access management, Sailpoint, Computer system Validation, gxp *Requirement 2* *Validation Engineer – Submission Systems – Foster City, CA* 1) 6 – 10 years of CSV experience. 2) Should have SME type knowledge. Key words: ECTD, CSV, Regulatory filings *Requirement 3* *Program Manager – Engagement Lead - Foster City, CA* Experience: • Over 10 years of business experience • Minimum of 5 years of experience in focus area • Bachelor’s degree • Recognized by clients and industry as an authority in the field • Excellent understanding of regulations, methodologies, and business practices • Extremely skilled at high-level client consulting and process facilitation • Recognized as the highest level of consultant demonstrated through a history of producing deliverables that meet or exceed client expectations • Regarded as a thought leader and accomplished expert in their area of expertise or technical area of focus • Independently performed major and strategic business activities including assessment, risk analysis, training, proposal development, and presentation activities • Assisted in formulating the approach to a project • Excellent team working skills as demonstrated by contributing the appropriate level of support to team efforts • Individual contributor with specific technical knowledge; may have advised the efforts of others • Demonstrated ability to teach, present technologies and methodologies, and support the sales of the Company’s service offerings • Leadership skills - led and facilitated meetings • Excellent teaching and mentoring skills • Effectively managed challenging and changing situations • Contributed to clear, well organized project meetings • Excellent writing skills as demonstrated by preparation of clear, well-organized documents • Communicated effectively with all levels of a team, internally and externally • Excellent interpersonal and communication skills as demonstrated by development of sound business relationships with clients over time • Developed client relationships • Basic understanding of system development life cycle • Knowledgeable of MS Office products • Hands-on experience in computer systems is preferred Responsibilities: • Ensure that the correct and appropriate assessment criteria, validation strategy and validation conclusions are identified • Bring technical excellence into all phases of the project life cycle, from the definition of the scope and approach to the project through the finalization of deliverables • Develop templates and documentation for assigned projects including SOPs and procedures, policies, guidelines, protocols, and summaries • Provide senior management level consulting to clients • Provide top-level technical leadership and support to Project Managers and consultants engaged in projects • Interface with the client on technical matters demonstrating technical depth • Perform quality review on final documents produced by Solution Architects, Senior Specialists, and Specialists • Problem solver in a variety of situations • Report to the Project Manager accurately on project activities; produce regular status reports that also include administrative matters • An expert within the Company, to our clients, and in the industry in a specific area • Provide leadership in the interpretation of regulatory and industry trends • Assist in the development and optimization of practice service offerings • Provide technical support to the sales team through presentations in sales meetings and by assisting in the development of the technical components of proposals • Contribute to business development through industry and high-level client presentations and meetings • Participate in developing and refining the Company’s methodology, including document outlines and templates • Lead the development and technology transfer of methodologies and practices • Actively participate in technical presentations in seminars, conventions, user-group meetings, or through relevant publications and articles • Mentor and advise the efforts of others • Share responsibility for the professional development of other consultants • Conduct client and vendor audits • May be required to perform the role of Project Manager • May participate in interviewing and recruiting new consultants Common Responsibilities: • Produce quality project deliverables • Demonstrate professionalism in the preparation and delivery of work • Identify client needs for additional support and new business opportunities and communicate them to Project Manager, Practice Director, and/or Account Manager • Continue to develop professionally, including knowledge of methodology, application areas, writing, and presentation skills • Maintain standards of professionalism, decorum, demeanor and appearance when performing company activities • Adhere to the confidentiality, protection of proprietary information, and other legal responsibilities • Be available to travel nationally The resumes should have the following at a minimum: 1) A reference to the FDA regulation “21 CFR Part 11” could also be abbreviated as “Part 11” 2) References to validation of large computer systems – “Validation”; “CSV” 3) One or more of the following: FDA, GAMP, QSR, IQ, OQ, PQ, UAT, GMP, GCP, GLP, GxP, GDP, SOP 4) Experience should include working for a pharmaceutical company 5) Reference to “Risk Based” compliance/validation 6) Types of technologies: HPQC 7) Type of Systems validated: SAP, Oracle, Trackwise, Documentum, Argus, AxWay a. Secondary systems: ArisG, ETQ, Compliance Wire, Plateau, Veeva, SalesForce, HPQC The following items don’t exclude from consideration but without the above the likelihood of a match is significantly reduced: 1) Experience with laboratory qualification/validation (processes, systems or instrumentation) 2) Experience with manufacturing qualification/validation (processes, systems, or equipment 3) Experience with facility qualification/validation (processes, or equipment) 4) Experience with infrastructure qualification/validation 5) Experience with Medical Device companies 6) Experience with Healthcare companies *Requirement 4* *Computer System Validation - Piscataway, NJ* *Duration: 9+ Months* We need validation people with Red Prairie Warehouse and/or SAP experience. Validation Job Description: Participate in the development of strategic compliance deliverables to support applicable regulations and internal policies and to ensure systems to be developed adhere to corporate SDLC methodology. drive understanding and adoption of Quality and Compliance standards. Ensure Quality & Compliance requirements are considered in any initiative or major change request. Ensure the compliance deliverables are updated and kept current with all applicable changes. Work with IT and business teams within HCS/CLS to drive/maintain/create Quality program. Align the development methodology with Compliance plans, policies and procedures. Effectively manage ongoing change control process (interface to IT support, impact analysis, release mgt, data changes, testing etc.). Build strong relationships with franchise quality business owners. Qualifications • 5- 7 years experience in Quality & Compliance with a Bachelors degree. • Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation. • Experience in Computer system validation. • Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/validation reports. • Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. • Experience in Software Development Lifecycle (SDLC). • Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures. • Experience in Change Control. • Experience on various FDA standards (21 CFR Part 11, 210, 211, 820) • Experience is creation of SOPs. • Knowledge of FDA guidance’s and industry standards (i.e., GAMP) • Hands on experience in HP Quality Center and QTP. • Strong verbal and written communication skills. • Able to work as a team player, lead a team or accomplish tasks without supervision. • Ability to work with remote teams and support several changes/projects simultaneously. • Flexibility to work with an onshore/offshore model. • Knowledge working with systems; such as, SAP, Red Prairie and data management systems *Requirement 5* *Key Words :VALIDATION ENGINEER, ORACLE EBS, ORACLE EBUSINESS SUITE Role :QA lead required at San Antonio, Texas* JD - The IT Quality Analyst Lead is responsible for administration and support of one or more IT Quality Assurance processes including Requirements Reviews, Test Strategy Development, Driving the Testing Process, and Driving Defect Administration. Working with different IT teams, this person insures that the process is understood and used appropriately, and that issues are resolved in a timely fashion. In addition, ensure that the process undergoes continuous improvement, and that process metrics accurately reflect key performance indicators. Teams with and guides project teams to insure high quality IT application implementations. Provides QA knowledge and testing experience to support application development. Provides administration services to one or more software tools used in the development process. Ensures documentation and practices meet quality standards, applicable regulatory compliance, company guidelines/policy using sound software quality practices. Ensures accuracy and completeness of all software quality records Author and implement high level and detail process specifications, and plans. Provide expertise in the review of all deliverables across the product lifecycle, ranging from requirements documentation, high level/detailed design, and code deliverables to packaged solutions for release. Report the test results in a structured way and advise on the quality of the deliverables (internal/external), and report on product quality to project management or test coordination Provide test strategy documentation Provide standardized QA deliverables set This position interacts with IT project development teams including Project Managers, Business Analysts, Developers, System Administrators, business subject matter experts, and others to develop and introduce new functionality into KCI systems. The new functionality helps KCI work more efficiently and effectively. BS degree in Engrg, Computer Science or Physical/Life Science 3 years experience in IT Quality Assurance, ITIL Experience, 3-5 yrs experience with HPQC, HP PPM Other skills required: Knowledge of software quality regulations and software lifecycle approaches. ? Well versed with software lifecycle processes and methodologies, with emphasis on quality assurance and testing best practices. ? Strong verbal and written communication skills, with ability to articulate the problem and solution space to different audiences. ? Excellent analytical, organizational and communication. Ability to manage multiple tasks concurrently. Ability to read and understand business and technical requirements. ? Self starter with strong process improvement and quality skills ? Ability to deal effectively with all employees (including Executive Management) and external business contacts while conveying a positive, service oriented attitude. ? Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment. Preferred Qualification Working hands-on knowledge with SVN and SVN automation. Experience with Oracle E-Business Suite (Version 11i and Release 12) Experience with Global software development Experience in a medical device manufacturing business IT environment ------------------------------ *Requirement 6* *Key Words :VALIDATION ENGINEER, ORACLE EBS, ORACLE EBUSINESS SUITE Role :Validation Engineer required at San Antonio, Texas * Position Summary: The Software Validation Engineer Associate is responsible for developing, reviewing and executing software validations including, Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). This person works with a Senior or Lead Software Validation Engineer to maintain IT non-product software applications in a validated state. Responsibilities: Provides support to the Senior or Lead Software Validation Engineer on validation planning and testing activities. Identifies gaps and contributes solutions to software validation processes, procedures and practices. Ensures documentation and practices meet quality standards, applicable regulatory compliance, company guidelines/policy using sound software validation practices. Ensures accuracy and completeness of software validation records (e.g., Validation Plan, IQ, OQ, PQ) Authors and implements high level and detailed test specifications, test plans, test cases and scripts. Participates in validation activities, IQ/OQ/PQ testing, general system testing, stress and stability testing. Reports test results in a structured way and advises on the quality of deliverables (internal/external). Reports on application and documentation quality Position Scope: This position interacts with IT project development teams including Project Managers, Business Analysts, Developers, System Administrators, business subject matter experts, and others to develop and introduce new functionality into KCI systems. The new functionality helps KCI work more efficiently and effectively. Qualification: BS degree in Engr, Computer Science or Physical/Life Science Experience: 1-3 yrs In an FDA regulated IT environment Skills required: Strong verbal and written communication skills, with ability to articulate the problem and solution space to different audiences. ? Excellent analytical, organizational and communication skills. Ability to manage multiple tasks concurrently. Ability to read and understand business and technical documents. ? Self starter with strong process improvement and quality skills ? Ability to deal effectively with all employees (including Executive Management) and external business contacts while conveying a positive, service oriented attitude. ? Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment. Preferred Qualification: Experience with HP Service Manager or HP Quality Center. Experience with Oracle E-Business Suite (Version 11i and Release 12) in a global environment Experience with Global software development Experience in a medical device manufacturing business IT environment --- *With Warm Regards * *Madhu Roy* GenuineIT LLC *Certified Women Owned Business* Making IT Happen… [image: cid:[email protected]] Ph: 832 539 3475 Fax: 281-605-5969/(512)949-5092 *E-Mail* :[email protected] *Gmail *: *nandimadhu74 , madhu.genuineitllc* *YM *: madhu_recruiter [image: cid:[email protected]] According to Bill S.1618 Title III passed by the 105th US Congress, this message is not considered as "Spam" as we have included the contact information. If you wish to be removed from our mailing list, please respond with "remove" in the subject field. We apologize for any inconvenience caused. -- You received this message because you are subscribed to the Google Groups "SAP ABAP" group. 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