• Sr. Specialist / Principal Specialist , Jobs in United States Of America

  • Boehringer Ingelheim India Pvt Ltd
  • United States Of America, Usa
  • Save Job
  • 0 - 3 Years
  • Posted : above 1 month

Job Description:


This is an expert-level individual contributor role, responsible for establishing, validation best practices and maintain and manage process and cleaning validation processes at BI Fremont to achieve company goals and department objectives Incumbent serves as the subject matter expert (serves as the site point of contact/process owner) for various validation topics (such as Process Validation and Cleaning Validation) Key member of Quality Validation department to support Change Control, Deviations and CAPAs relevant to validation topics, and take part in Inspectional Readiness Core Team Attends cross-functional meetings representing Quality Validation Works with colleagues at other BI sites, clients and external contractors to advance projects and to meet department goals Able to lead validation risk assessments, conduct process/cleaning validation workshops, and provide site wide validation training Coordinates with global teams to apply network policies, develop site-specific validation procedures and shared practices as applicable

Incumbent independently exercises judgment and discretion within defined practices and policies in selecting methods, techniques and evaluation criteria for resolving complex problems, where analysis of situations or data requires in-depth evaluation of various factors, and considerable judgment in resolving problems and making routine recommendations Independently Managers Validation Projects to on time completion Applies project management skills and concepts to lead or manage complex projects that have significant business influence

Provide guidance to team members as they lead validation projects by providing guidance on regulated industry practices and documentation Responsible for mentoring and coaching Staff Fosters quality collaboration among the site and staff Acts as a delegate to sign official documentation in the place of management, and makes difficult decisions with little time for deliberation that can have a direct impact on active manufacturing and Quality operations

Implements continuous improvement efforts as it relates to Validation activities Attends cross-functional meetings as responsible Validation representative Works with clients and external vendors to prepare for audits and inspections Works with functional areas to provide audit responses and ensure inspection readiness Attends cross-functional meetings as responsible Validation representative

Ensures programs and processes are aligned with Corporate/Global BioPharma and maintained in accordance with cGMP/Quality/Compliance regulations

Duties & Responsibilities

Responsible for ensuring cleaning and manufacturing processes are validated to required standards Also provide QA oversight to E&T and ensure equipment/systems remain in a validated state Manage troubleshooting efforts for protocol discrepancies Performing cleaning assessments per planned schedule to support New Product Introductions (NPIs) Investigates deviations associated with failures in cleaning or process validations Applies theory, technical principles, and judgment to address a broad range of difficult projects/problems
Reviews and approves controlled documents relating to processes, cleaning, equipment, and computer systems validations
Reviews batch records/procedures to ensure that the process is within validated state Performs validation impact assessments when changes are proposed
Responsible for independently leading and completing complex/critical projects as validation representative for the organization
Presents the validation approach and protocol results to peers and management as required Works with global network to align practices and identify efficiencies Assists or interacts with regulatory agencies as necessary Assists Associate Director in maintaining performance boards for the department and track Key Performance Indicator metrics
Reviews and interprets data for accuracy for completed validations/re-validations to ensure requirements and acceptance criteria are met
Prepares report packages by analyzing and summarizing the data to support test and protocol requirements
Provides technical input to validation deviations; provides assessments for change requests on direct impact systems; and identifies qualification requirements to ensure the validated state is maintained
Leads and manages validation sub-team to engage with internal and client teams and to ensure deliverables are met on time Operates using independent judgment and discretion with little oversight
Serves as Subject Matter Expert for internal or external customers Participates in inspection readiness activities and is significantly involved in inspections by regulatory agencies
Coach and train junior level staff on validation as needed Mentor and support junior staff by providing guidance in decision making, determining validation strategy, authoring complex documents and executions
Provides technical support and guidance to other project team members in protocol preparation, execution and data interpretation
Provides guidance to junior team members on proper documentation and guidance interpretation
Quality assurance oversight (as applicable)
Works independently to provide quality assurance oversight of commissioning and qualification activities for adhering to compliance with cGMPs, regulatory, industry, and corporate requirements Quality oversight responsibilities include ensuring adherence to SOPs and requirements, providing concurrence on protocol discrepancies, providing quality approval of impact assessments for changes to equipment and processes, risk management, and to ensure documentation and investigations meet all requirements Ensures Quality decisions are made, with consultation from Quality colleagues, which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas
Independently serves as validation representative in decision making as needed in the absence of the department head
Leads improvements and revisions to validation procedures and practices Instrumental in providing recommendations to global validation procedures and play key role in implementing at site
May be called upon to provide oversight, coaching and mentoring to the team Shares learnings and improvements across functional group and the business including the on-going training of junior team members
Serves in the capacity of department head regarding signature authority, and decision making

Requirements for the Senior Specialist, QA Validation

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 16th Mar 2020

Key Skills:

Company Profile:

Boehringer Ingelheim India Pvt Ltdarfix

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