Overview
Validation Compliances Gxp Consultant/On-Site Jobs in Bangalore, Karnataka, India at QAAgility Technologies
Position: Validation Compliances Gxp Consultant (On-Site)
Job Title- Validation Compliances Gxp Consultant
Job Type- On-site (Bengaluru)
Experience- 8+ Years
Job Description-
Job Summary:
We are seeking a highly skilled Validation Responsible Consultant to oversee and manage the validation processes of our systems, processes, or products, ensuring compliance with industry standards and regulations. The ideal candidate will have extensive experience in system validation, quality assurance, and compliance management, with a strong focus on meeting regulatory requirements and ensuring operational efficiency.
Key Responsibilities:
Lead and manage system validation activities for projects to ensure compliance with relevant regulatory standards (e.g., FDA, GMP, ISO, 21 CFR Part 11).
Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports for systems and processes.
Coordinate with cross-functional teams (e.g., IT, Engineering, Quality Assurance) to ensure validation requirements are met and maintained throughout the system lifecycle.
Identify, assess, and mitigate risks related to system validation processes.
Review and approve validation documentation, ensuring that all documentation meets regulatory and internal standards.
Ensure proper documentation and traceability for all validation activities, including deviations and corrective actions.
Manage the implementation and maintenance of validated systems, ensuring compliance during ongoing use.
Act as the primary point of contact for all validation-related queries and issues, providing guidance and expertise as required.
Conduct impact assessments for changes to validated systems or processes and ensure appropriate re-validation is performed.
Collaborate with stakeholders to ensure that validation activities align with business needs and project timelines.
Monitor and report on the status of validation projects and activities, highlighting any issues or delays to senior management.
Provide training and support to internal teams on validation methodologies, processes, and best practices.
Support audits and inspections by regulatory agencies, providing necessary validation documentation and addressing findings.
Required Skills &
Qualifications:
Bachelor’s degree in Life Sciences, Engineering, Information Technology, or a related field.
Proven experience as a Validation Consultant, or in a validation role within regulated industries (e.g., Pharmaceuticals, Biotech, Medical Devices, IT).
In-depth knowledge of industry regulations and standards, including GxP (Good Laboratory Practice, Good Manufacturing Practice), 21 CFR Part 11, and ISO 13485.
Experience in writing and executing validation protocols (IQ, OQ, PQ) and validation reports.
Strong project management skills, with the ability to lead validation efforts, coordinate resources, and meet deadlines.
Strong analytical and problem-solving skills, with the ability to identify issues and propose corrective actions.
Excellent communication skills, both written and verbal, with the ability to interact effectively with various stakeholders (management, teams, regulatory bodies).
Knowledge of risk-based validation approaches and best practices.
Proficiency with validation tools and systems is a plus.
Preferred Qualifications:
Certification in Validation or Quality Management (e.g., Certified Quality Engineer (CQE), Certified Validation Professional (CVP)).
Experience with automated systems validation and cloud-based platforms.
Familiarity with electronic records and electronic signatures (21 CFR Part 11) and computer system validation (CSV).
Prior experience with regulatory inspections (e.g., FDA, EMA, ISO audits) and audit preparation.
Title: Validation Compliances Gxp Consultant/On-Site
Company: QAAgility Technologies
Location: Bangalore, Karnataka, India
Category: Quality Assurance – QA/QC (Regulatory Compliance Specialist, Quality Engineering), Engineering (Regulatory Compliance Specialist, Quality Engineering)
