Principal Pharmaceutical Systems Validator

3 days ago

Hyderabad Secunderabad Telangana, India beBeeValidation Full time ₹ 1,04,000 - ₹ 1,30,878

Sr Validation Engineer

">
  • Advising clients on how to meet compliance requirements using a risk-based approach.
  • Develop validation documentation and standard operating procedures for various GxP applications.
  • Develop test protocols that thoroughly test business requirements.
  • Provide test execution oversight and assist with deviation recommendations as required, work with clients to develop validation plans to ensure that, at the end of the project, the system meets GxP requirements.
  • Work with client business functions and domain experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required
  • Development of test / validation scripts based on software design and configurations.
  • Develop IQ/OQ scripts as required.
">

What We Expect Of You

We value diversity and individuality in our team. Each member brings unique contributions to serve patients.

">
  • Doctorate degree OR
  • Master's degree and 4 to 6 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR
  • Bachelor's degree and 6 to 8 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR
  • Diploma and 10 to 12 years of Life Science / Biotechnology / Pharmacology / Information Systems experience
">

Preferred Qualifications:

Functional Skills:

Must-Have Skills:

  • Demonstrated experience with minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations / GAMP
  • Experience with regulatory agencies - FDA, EMEA, CFDA, and other regulatory agencies
  • Proven leadership skills with the ability to multitask and lead multiple validation projects
  • Thorough understanding of the principles of GAMP, SDLC methodologies and testing standard methodology.
  • Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
  • Expertise with ALM testing and ALM software (HP)
  • Expertise in use of Veeva (all modules - CDocs, QMS, RIM, DocuSign, etc)
  • Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance.
  • Good-to-Have Skills:
  • Ability to work independently, excellent problem-solving and professional written communications skills.
  • Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project), Experience with Smartsheets, Salesforce, Tableau a plus
  • FDA Audit experience a plus & working with regulatory agencies
  • Experience with enterprise CDS platform software (Empower/Chromeleon/Unicorn)
  • Soft Skills:
  • Excellent leadership and team management skills.
  • Strong transformation and organizational change experience.
  • Ability to work effectively with global, virtual teams.
  • Excellent analytical and solving skills.
  • Ability to prioritise successfully.
  • Strong presentation and public speaking skills.
  • Strong verbal and written communication skills.
  • High degree of initiative and self-motivation.
">

We Offer

A dynamic environment where you can grow professionally and contribute to serving patients.

"] ,

  • System Validation Specialist

    7 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeValidation Full time

    Senior Validation SpecialistWe are seeking a highly skilled and experienced Senior Validation Specialist to join our team. As a key member of our team, you will be responsible for ensuring the accuracy and reliability of our clinical data management systems.ResponsibilitiesDevelop and implement validation strategies aligned with regulatory...

  • Digital Systems Validator

    2 days ago

    Hyderabad, Telangana, India beBeeCsv Full time ₹ 20,00,000 - ₹ 25,00,000

    Azurity Pharmaceuticals, a specialty pharmaceutical company focusing on innovative products for underserved patients, seeks a motivated IT professional.The company's patient-centric products span multiple markets and have benefited millions of patients. We are an inclusive workplace and an Equal Opportunity Employer.We are looking for individuals with...

  • System Validation Expert

    6 days ago

    Hyderabad, Telangana, India beBeeValidation Full time ₹ 1,00,00,000 - ₹ 1,50,00,000

    Job Title: Business System Analyst - Validation SpecialistThe position requires collaboration with system architects and product owners to develop a validation strategy for Amgen's R&D Veeva Vault Platform and its hosted applications.Key Responsibilities:Create test cases, protocols, and validation documents within the Veeva Validation Manager Vault.Provide...

  • Method Validation Specialist

    2 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeValidation Full time ₹ 15,00,000 - ₹ 20,00,000

    **Job Opportunity:** We are seeking a highly skilled Method Validation Specialist to join our team.Responsibilities:Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and quality requirements.Design, execute, and document method validation protocols, including accuracy, precision, specificity,...

  • Pharmaceutical Science Specialist

    2 weeks ago

    Hyderabad / Secunderabad, Telangana, India beBeeAnalytical Full time

    Scientific Analyst RoleThe primary focus of this position is to develop and validate analytical methods for various pharmaceutical products.Key Responsibilities:Develop, execute, and monitor stability studies according to ICH guidelines.Prepare and review protocols, reports, method validation documents, and specifications.Operate and maintain sophisticated...

  • System Validation Specialist

    3 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeSystem Full time ₹ 1,04,000 - ₹ 1,30,878

    System Validation SpecialistRole Overview:Perform in-depth validation of system updates, patches and new features to ensure robust system functionality.Responsibilities:Collaborate with internal teams, external vendors and business partners to resolve dependencies and bottlenecks for critical issues.Develop comprehensive test plans and scenarios to verify...

  • Business Validation Specialist

    7 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeValidator Full time

    Job DescriptionWe are seeking a skilled professional to join our team as a Validation Associate Analyst. The successful candidate will be responsible for planning, coordinating, and executing validation activities, including qualification and validation of data products and software applications.The ideal candidate will have experience in validation in a...

  • MS&T Validation Specialist

    8 hours ago

    Hyderabad / Secunderabad, Telangana, India beBeeTechnical Full time ₹ 8,00,000 - ₹ 12,00,000

    Key Role in MS&T OperationsJob SummaryWe are seeking a highly skilled Validation and Life Cycle Management Expert to join our team. The ideal candidate will have a strong background in organic chemistry and experience with process and cleaning validations.Responsibilities:Prepare and update Risk Assessments and Validation related documentation, ensuring...

  • Senior Validation Expert

    7 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeValidation Full time

    Job DescriptionWe are seeking a highly skilled and experienced Validation Specialist to join our team. In this role, you will be responsible for ensuring the quality and integrity of our products by developing and implementing effective validation strategies.Your primary focus will be on process and cleaning validation, as well as providing technical...

  • System Validation Engineer

    4 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeGraphics Full time ₹ 1,04,000 - ₹ 1,30,878

    As part of the embedded processor architecture, engineering and solutions team, you will play a crucial role in validation on graphics drivers across multiple operating systems.This involves being hands-on in creating comprehensive validation plans, test cases, and use cases to improve the effectiveness through thorough coverage of all features enabled on...