Principle Quality Assurance Compliance Specialist
: Job Details :

Business: Critical Care

Department: Quality Assurance (Electronic System)

Location: Bethlehem

Job Overview

The purpose of this role is to define the roles and function for the Principal Quality Assurance Compliance Specialist Electronic Systems

Key Stakeholders: Internal

Corporate IT /QA, Site Management, All Departments

Key Stakeholders: External

FDA or other health organizations

Reporting Structure

Reports to QA Associate Director

Essential Duties and Responsibilities

* Ensure all the computerized systems meeting the 21 CFR Part 11, EU ANNEX 11and GAMP5 guidelines requirements.

* Perform, review & approve computerized system validation life cycle deliverables.

* Responsible for implementation and compliance of data integrity at site as DICO (Data Integrity Compliance officer).

* Implement regimen of Data integrity checks on shopfloor and updating of Data Integrity Risk Assessment (DIRA).

* Responsible for handling and compliance of SOPs related to Data Integrity & IT systems.

* Review / conduct of investigations related to Data integrity, Computerized Systems, and engineering department as applicable.

* Coordination for data integrity and IT-systems projects with stakeholders at site and corporate.

* Handling & Participation in internal & Data Integrity audits.

* Involve in selection of Data Integrity (DI) champions & impart necessary trainings to the DI champions.

* Review of Change controls, Deviations, CAPA and other QMS tools.

* Review of Periodic review reports.

* Participated in supplier assessment for Computerized Systems, instruments & equipment's etc.

* Review approve the schedules of data back-up & restoration, time synchronization etc.

* Audit trail reports review of computerized systems.

* Review and ensure the compliance of user management activities of Computerized Systems.

* Preparation / review of the quality risk assessments i.e. part 11 compliance, data integrity etc.

* Review the Qualification documents of the manufacturing equipment's, facility, utilities and associated ancillary systems.

* CAPA effectiveness verification.

* GMP compliance verification for the manufacturing equipment area, utilities and testing instruments.

* Review of software application qualifications.

* Comply with SHE Guidelines, SHE Rules and Regulations. Comply with usage of PPE wherever applicable.

* Observe noncompliant acts and conditions and take corrective & preventive actions immediately, as necessary.

* Report any incident/accident/near miss/illness to the superiors.

* Follow company's quality procedures, standards, and specifications.

* And any other job as may be assigned to you from time to time by HOD.

* Also responsible for the work of the senior, in absence of senior.

Key Competencies (knowledge, skills and abilities every person must possess to be successful)

* Critical Thinking - using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.

* Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers.

* Excellent verbal and written communication skills.

* Creative and able to present various solutions.

* Energetic, enthusiastic and motivational disposition.

* Maintain confidentiality.

* Coaching skills.

Education / Experience

* Bachelor's degree in relevant scientific quality assurance / technical field.

* 5+ years of experience.

* Strong understanding of pharmaceutical cGMP, industry standards, and regulations.

* Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels.

* Expert level user for Quality computer systems, Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems.

* Thorough understanding of computer system validation and GAMP requirements.

* The ability to analyze data/trends to make sound regulatory interpretation while preparing metrics and reports.

* The ability to drive projects in relation to implementation of new workflows and updates to new systems.