Location: Ringaskiddy, Ireland
Department: Quality
Reference: VN1049
QA Document Controller
Summary Of Role
Provide administrative support to the Quality function for Document Control, printing, issuing and maintenance of high GxP documentation for Production and Quality Control (QC) functions.
Key Responsibilities
Scope of responsibilities include - but are not limited to:
* Document Control support on Master Control Documentation System.
* Printing and issuance of Quality Analytical Proformas and Sample Logbooks.
* Printing and issuance of Cleaning PRS’s (Process Record Sheets).
* Printing and issuance of Production PRS’s (Process Record Sheets).
* Controlled issuance of Work Instructions.
* Controlled issuance of logbooks including creation and maintenance of site inventory of Logbooks.
* Maintaining timely plan for issuance of all GxP documentation.
* Point of contact for Production, QC and Supply Chain Management for issuance and planning of high GxP documentation.
* Responsible for the maintenance, scanning and archiving of completed GxP documentation.
Other Responsibilities
* Managing the Production document filing system, including booking in/out of documents, archiving/retrieving, maintenance of central database.
* Support Quality function for document retrieval during customer / Regulatory audits.
* Provide suggestions on areas above to support continuous improvement as part of the Site goals.
Qualifications/Experience
Requirements
* Basic level of Education - additional Certification and/or interest in Quality for equivalent high GxP industry is desirable.
* Proficiency in basic Microsoft applications including Word & Excel and comfortable working with IT solutions.
Key competencies required for the role
* High level of attention to detail and awareness of cGMP standards.
* Excellent organisational skills and works on own initiative.
* Excellent communication skills with ability to work cross-functionally.
Why consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complemented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.
We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.
Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.
Sterling Pharma Solutions is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.
Be caring. Be transparent. Be willing. Be reliable.
Apply now #J-18808-Ljbffr