Validation and Quality Assurance Specialist
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In this role, you will be responsible for coordinating and participating in the validation and quality assurance of site equipment, utilities, processes, and software to ensure compliance with industry standards.
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Responsibilities:
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1. Develop and implement a comprehensive Site Validation Master Plan.
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2. Create and execute Project Validation Plans and schedules.
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3. Generate validation protocols and final reports in accordance with cGMP standards.
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4. Collaborate with cross-functional teams to ensure seamless execution of validation activities.
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5. Identify and mitigate risks associated with validation and quality assurance processes.
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6. Stay up-to-date with regulatory requirements and industry developments to ensure ongoing compliance.
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7. Provide training and support to team members on validation and quality assurance procedures.
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8. Contribute to the development of process improvements and best practices within the organization.
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9. Ensure accurate and timely documentation of all validation and quality assurance activities.
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10. Support the implementation of corrective actions to address any deviations or non-compliance issues.
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11. Develop and maintain relationships with internal stakeholders to facilitate effective communication and collaboration.
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12. Participate in audit preparation and respond to auditor inquiries.
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13. Compile and analyze data to inform decision-making and drive business improvement.
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14. Implement and maintain a culture of quality and excellence within the organization.
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15. Engage in ongoing professional development to enhance knowledge and skills in validation and quality assurance.
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16. Lead by example and demonstrate a commitment to integrity, ethics, and continuous improvement.
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17. Stay informed about industry trends, emerging technologies, and regulatory changes to stay ahead of the curve.
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18. Coordinate and participate in internal and external audits, as required.
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19. Work collaboratively with other departments to achieve organizational goals.
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20. Take ownership of assigned tasks and projects to ensure successful delivery.
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21. Responsible for ensuring that all work is performed in compliance with relevant laws, regulations, and organizational policies.
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22. Manage competing priorities and deadlines to deliver results in a fast-paced environment.
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23. Communicate effectively with stakeholders at all levels to ensure clear understanding and alignment.
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24. Develop and maintain documentation, records, and reports related to validation and quality assurance activities.
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25. Investigate and report any discrepancies or non-compliance issues promptly.
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26. Establish and maintain effective working relationships with colleagues, managers, and clients.
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27. Actively contribute to the creation and maintenance of a positive and inclusive work environment.
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28. Perform other duties as assigned by management.
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29. Validate and verify the accuracy of information provided by internal and external sources.
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30. Report any potential security incidents or vulnerabilities to the appropriate authorities.
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31. Help develop and execute business strategies and initiatives that align with the company's mission and vision.
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32. Utilize various tools and technologies to enhance productivity and efficiency.
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33. Document and report any unusual occurrences or anomalies during validation and quality assurance activities.
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34. Execute standard operating procedures (SOPs) and work instructions according to established guidelines.
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35. Facilitate and lead cross-functional project meetings, workshops, and training sessions.
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36. Practice confidentiality and discretion when handling sensitive or proprietary information.
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37. Maintain an awareness of health and safety regulations and guidelines, adhering to them at all times.
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38. Support and promote the company's brand, values, and mission through daily interactions and activities.
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39. Engage in regular self-assessment and seek feedback from peers and supervisors to improve performance.
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40. Remain adaptable and flexible in response to changing priorities, requirements, and circumstances.
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41. Ensure compliance with environmental and sustainability initiatives and regulations.
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42. Implement Lean principles and Six Sigma methodologies to drive continuous improvement.
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43. Monitor and manage budgets, financial resources, and assets as delegated.
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44. Exemplify the company's commitment to customer satisfaction, loyalty, and retention.
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45. Promote and adhere to the company's code of conduct and ethical standards.
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46. Uphold and embody the company's values and mission in all aspects of work and behavior.
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47. Make sound judgments and decisions based on available data, facts, and logical reasoning.
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48. Maintain accurate records and logs of validation and quality assurance activities.
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49. Represent the company in a professional manner at external events and meetings.
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50. Assist in the development and implementation of technical documents, such as SOPs, guidelines, and technical notes.
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51. Collaborate with subject matter experts to provide expertise and guidance on complex topics.
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52. Conduct and participate in root cause analysis and corrective action investigations.
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53. Understand and comply with relevant laws, regulations, and organizational policies.
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54. Utilize advanced analytical techniques and problem-solving methods to resolve complex issues.
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55. Interpret and communicate complex technical information to both technical and non-technical audiences.
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56. Provide mentorship and coaching to junior team members to enhance their skills and knowledge.
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57. Enhance knowledge and skills through participation in training programs, workshops, and conferences.
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58. Seek feedback and input from others to foster a collaborative and inclusive work environment.
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59. Effectively prioritize tasks and manage time to meet deadlines and achieve objectives.
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60. Lead by example and inspire confidence in colleagues, supervisors, and customers.
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61. Develop and implement plans to address gaps in knowledge, skills, or performance.
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62. Operate in accordance with established procedures and guidelines.
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63. Communicate clearly and concisely in written and verbal form.
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64. Apply creative problem-solving skills to tackle complex challenges.
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65. Offer assistance and support to colleagues as needed.
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66. Be proactive in seeking opportunities for growth and development.
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67. Accept responsibility for own actions and outcomes.
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68. Prepare and submit reports, proposals, and presentations as required.
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69. Preserve confidentiality of sensitive information and protect intellectual property.
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70. Comply with applicable industry standards, codes, and regulations.
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71. Keep current with new developments and advancements in technology and methodology.
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72. Participate in process improvement initiatives to enhance efficiency and effectiveness.
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73. Directly interact with multiple stakeholders, including internal teams and external partners.
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74. Develop and present training materials, workshops, and training sessions as needed.
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75. Consistently adapt to changing situations and unexpected obstacles.
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76. Self-assess and provide constructive feedback to oneself and others.
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77. Employ situational awareness and tact when dealing with conflicts or disagreements.
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78. Adhere to ISO 9001:2015, GxP, and other relevant standards and frameworks.
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79. Minimize risk to people, assets, and the environment through adherence to proper procedures and precautions.
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80. Deliver high-quality services that consistently meet or exceed expectations.
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81. Continuously update knowledge and skills to stay current with industry advancements.
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82. Present innovative ideas and solutions to address complex problems.
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83. Align individual goals and objectives with those of the organization.
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84. Consult with and advise senior leadership on matters related to quality and assurance.
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85. Carry out research and analysis to identify areas for improvement and propose recommendations.
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86. Obtain and document stakeholder input and feedback to guide future initiatives.
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87. Debrief and evaluate lessons learned to refine approaches and minimize rework.
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88. Focus on long-term strategic planning and its impact on operations and resource allocation.
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89. Address unforeseen disruptions, accidents, or emergencies while maintaining operational stability.
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90. Drive bottom-line growth through efficient processes and resource allocation.
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91. Review and revise business strategies and initiatives to ensure continued relevance and viability.
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92. Connect technical, practical, and theoretical aspects of a topic to derive insightful conclusions.
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93. Build capacity among staff to ensure sustained capability and flexibility.
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94. Explore diverse points of view and incorporate alternative perspectives into decision-making.
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95. Study and apply SWOT analysis to determine key strengths, weaknesses, opportunities, and threats.
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96. Clearly articulate business needs and prioritization criteria to influence resource allocation.
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97. Interfacing with clients to understand their expectations and adjusting workflows accordingly.
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98. Effective use of global management tools and metrics to generate insights and track performance.
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99. Improving system thinking capabilities to excel in strategic planning, and deliver immediate value in most complex business environments.
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100. Exploring electronic test lab automation to move towards complete digital transformation.
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101. Emphasizing soft-skills like assertiveness, persuasion, influencing change and building trustful relationships, whenever possible.
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102. From cost-centric and pure output-driven measurement focus shifting toward emphasis on outcomes and what we call now meaningful product usage.
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103. >>Migrating functionality from legacy systems to platform-independent & open-source alternatives combined with Zero-Touch Provisioning/ZTP.
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104. Speed processing along one service-oriented architecture flow definition encompassed around ProSAEC Microservices connecting micro-processes produced utilizing two-faceted industry connection layer.
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105. >Top-ranked scored paper going very well featuring multi-system/emerging singular movie played programmatically defusing algorithmic descriptions implementing new lifestyles otherwise possessing diversity hiring microservice overcoming bottleneck cases triggered rolling leak outbreaks ..!],