Description

BioPharma Consulting JAD Group is looking for a dedicated Validation Compliance Coordinator to join our team. The Validation Compliance Coordinator assists with the tracking, coordination, and closure of Validation deviations, CAPAs, and change controls / action items, and assists in supporting other validation activities.
Responsibilities:

Functions:

Responsible for participating in the following activities within the Validation department:
Support the Validation organization during internal and external audits.
Support the external and internal Audit Programs to be in an acceptable state of compliance.
Work with Quality and Validation management to implement changes to validation program improvements.
Responsible for Validation audit preparations, assisting internal audits and client audits with site documentation collation.
Coordinates the initiation of new deviations.
Leads deviation, CAPA, and change control closure for Validation.
Assists with leading Root Cause Analysis Investigations
Schedules and facilitates post Validation lessons learned.
Supports leading the completion of periodic reviews for quality documents.
Provides and maintains metrics around requalification and periodic reviews, including deviation, CAPA and change control status.

Deviation Investigation:

Lead investigations for deviations and events.   
Generate impact assessments for deviations and events.
Lead investigations including identification of root and/or contributing causes.     
Ensures required Management and Quality approvals on final investigations while satisfying established due dates.  Facilitates corrective and preventive action agreement with stakeholders. 
Support client due diligence and Quality audits as well as regulatory inspections. 
Promptly notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

Equipment Compliance Coordination

Support the routine maintenance and calibration of Validation equipment by the monitoring and scheduling of any preventative or corrective work required.
Ensure all equipment utilized on the floor for Validation execution is entered correctly into the Building Management System.
Is the point of contact for client and regulatory inspection support with trends and metrics.
All other duties as assigned.

Required Skills & Abilities:

Excellent oral and written communication skills, interpersonal and organizational skills.
Excellent organizational, analytical, data review and report writing skills.
Practical understanding of equipment used in bioprocessing (downstream and/or upstream).
Proficient with Microsoft Office applications.
Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required.
Ability to multitask and easily prioritize work.
Experience working in pharmaceutical industry.

Requirements

Qualifications:

Bachelor’s Degree in an Engineering discipline or Life Science and four (4) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role; OR
Associate degree and six (6) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role.; OR
High School Diploma or GED and eight (8) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role.

Preferred Qualifications:

Experience authoring CAPAs, change controls, and deviations
Experience with validation of automated systems and manufacturing processes is a plus.
Knowledge of FDA regulations and compliance guidelines related to validation.

BioPharma Consulting JAD Group

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Validation Compliance Coordinator