Manager, Quality Assurance Documentation

GRIFOLS, S.A.

1d•Onsite

About The Position

The QA Manager is responsible for managing QA Documentation Department and systems. QA Documentation Manager responsibilities include: Change Control Management and Document Management System. Ensures that all changes to documents, facility computer and packaging components are properly documented, justified and approved. Manage/supervise QA staff and ensure their growth/development through effective performance counseling and training.

Requirements

BS degree in Biology, Chemistry, related Science or Engineering
5-8 years of experience in Quality Assurance and 3-5 years working in pharmaceuticals
Supervisory experience
Knowledge of Regulatory requirements
Strong analytical, organizational and interpersonal skills
Extensive knowledge of cGMPs as specified in the CFR/USP and EP Pharmacopeia / ICH and ISO Guidelines.
Excellent written/verbal/leadership skills
Must be able lift, push or pull 50lbs

Responsibilities

Oversees and provides direction in the maintenance of the change control system and Document management system.
Reviews all change requests for clarity, purpose, justification and Regulatory requirements
Prepares information for annual reportable changes to be submitted to FDA
Routine reporting of document workflow status and upcoming/overdue procedures for periodic review
Evaluate and implement process and system improvement
Site representative as system owner for groups consisting of various Grifols sites for benchmarking and harmonization efforts
Ensures that product impacted by change is placed on hold
Responsible for design, development, revision of packaging and labeling
Maintains effective communication with management
Manages operational budget
Chairs all change boards.
Give guidance and support to production on cGMP compliance
Provides support, direction and coaching to subordinate employees in the areas of the QA department
Participates in regulatory and internal inspections/ audits including providing written responses as applicable for area of responsibility.