QA Specialist

Location: Ringaskiddy, Ireland
Department:
Reference: VN1002
Summary of role
The purpose of the role is documentation review and batch release, APQR preparation and change approver

Your responsibilities
  • Product quality & compliance with GXP; including appropriate reporting and escalation of any product quality or GXP incidents or non-compliance
  • Escalation to management of any activities that potentially compromise the independence of the quality organization or the quality of the product; Completeness & accuracy of documents & records
  • Review all relevant documentation including batch records, CoAs, process deviations prior to batch release. 
  • Make final decision on the appropriate batch status for Intermediate and APIs and disposition appropriately taking into consideration any legal or regulatory requirements.
  • Manage the timely disposition of all Intermediate and API batches.
  • Management of process deviations including approval. Deviations to be approved in line with associated timelines and batch release. Close out of Process deviations once corrective actions completed.
  • Deputise for approval of QC deviations as required.
  • Review and approve all process-related master documentation – master manufacturing procedures, QRAs, master batch records, recipes etc. as required.
  • Review and approve Process Validation (protocols and reports) and ensure validation protocols/reports are generated in compliance with company policies and GMP guidelines.
  • Review and approve cleaning documentation in a timely manner prior to batch release Review of Testing Monographs on Master Control as required.
  • Review and approve SAP changes to inspection plans.
  •  Review and approve setup documents.

Requirements for the role
  • BSc in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
  • 3+ years’ experience working in the pharmaceutical industry in a Quality Role or a Production Role.
  • Excellence in influencing people, in negotiation and communication skills as well as potential for excellence in leadership.
  • Excellent organizational skills in order to drive projects with a proactive and action-oriented attitude. Skilled at identifying and resolving areas of concern in relation to quality.

Closing Date: 22nd November 2024
 
Why consider Sterling? 
 
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years' experience in developing and manufacturing Active Pharmaceutical ingredients (APIs). This is complemented by Antibody Drug Conjugate (ADC) R&D bioconjugation services 
 
We are a fast growing, dynamic business with facilities in the UK, US and Europe, where we employ 1300 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 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.