Address Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
General Purpose of Role:
Maintain controlled documentation within the company’s electronic document management system and provide general administrative support to the QA Department.
Main Responsibilities:
- Manage documents within the e-QMS
- Create new GxP documents within e-QMS
- Track and facilitate document change requests
- Communicate document review requirements to department managers
- Produce monthly document status reports
- Control the issue, distribution and withdrawal of e-documents
- Issue documents for training
- Write and author Standard Operating Procedures and instructional documents within scope of duties
- Coordinate scanning and archiving of hardcopy documents
- Manage QA/QP and Client audit calendars
- Support client audit arrangements (as required)
- Administration of batch records for QP review
- General administration tasks (e.g. Travel arrangements, completion of purchase orders, meeting minutes etc.)
- Assist with GMP software validation as required
- Other duties as required with job level
Outcomes of Role:
- Support the Head of QMS in maintaining controlled documents in line with GxP requirements
- Support site personnel by facilitating document creation and change
- Become a subject matter expert for electronic document management system
- Ensure all hardcopy documents are appropriately controlled and archived
Join us and be part of building the bridge between life changing therapies and patients.
Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
