The Quality Specialist is responsible for supporting Quality Systems
Quality Specialist: Pharmaceuticals: Dublin
The Quality Specialist is responsible for supporting Quality Systems such as documentation, complaints and audit systems, etc. across the business. Communicates to multiple departments and supervision to provide timely process and issue updates. Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams. Participates in reviews and structured processes for continuous improvement. Trains other local and off-site personnel and participates in resolving basic/moderate issues.
- Creating GMP documents according to approved templates/procedures and managing the change control approval cycle
- Review and approve GMP documents received from contractors e.g. master batch records, analytical test methods, protocols etc.
- Manages issuance of required distribution copies of documents (internal and external) ensuring retrieval/destruction at obsolescence
- Reviews quality documentation (COAs, temperature charts, etc) for compliance
- Responsible for archiving requirements
- Perform a quality review on batch documentation received from contract manufacturing / packaging sites.
- Monitor / Liaise with Quality of contractors to ensure timely receipt of batch documentation and resolution of quality issues
- Assisting with checks to ensure assessments related to documents are current.
- Supports user training for Quality Systems.
- Supports GMP / GDP training; provides training materials and/or conducts training sessions
- Receives and logs complaints; gathers information from call centre and complainant; generates acknowledgement letter and sends to complainant.
- Assesses and evaluates the criticality of complaints, escalating those that may be a FAR.
- Provides notification of complaints and status to key stakeholders.
- Assists and/or performs investigation of the complaint.
- Liaise with Medical Information (MI) and Pharmacovigilance and Risk Management (PVRM) and Safety on complaints / AEs.
- Follows complain process through to resolution and generates/sends close-out letter.
- Enters complaint data daily and maintains product complaint database and files.
- Participates or serves as lead Quality Representative on process improvement initiatives.
- Participates in gap analysis and recommends revisions to SOPs.
- Collaborates with cross functional partners to identify and implement improvements.
- Tracks and provides metrics to management for areas of responsibility; notes trends and escalates to management.
- Authors deviation/investigation reports for incidents which occur in area of responsibility.
- Participates in performing internal audits.
- Participates in resolving complex issues and helps drive root cause determination.
- To review / prepare annual product quality reports.
- Performs other duties as directed.
- Supports Cross-functional and/or multi-site projects such as software evaluation, process presentations, etc
- Respond to and escalates events identified as nonconformance.
- Performs periodic review of quality documents and updates as necessary according to approved procedures.
- Trains personnel on procedures and QS requirements; ensures adherence to SOPs related to areas of responsibility.
- Understands and stays current with regulatory guidance.
- Supports site inspections/audits by providing requested documentation, acting as SME for primary job functions and acting as scribe as needed.
- Follow all procedures to ensure a safe and compliance work environment.
Education and Experience:
- College degree in science related field
- 3+ years prior Pharmaceutical or Medical Device experience.
- Understanding of Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs).
- Knowledge of US and EU Regulations (ICH, EU, GMPs, US CRFs, ISO, etc.).
- Knowledge of electronic data systems.
- Able to communicate effectively with other departments, management and operations personnel.
- Customer/Stakeholder focused (understands impact of daily work to compliance and overall business)
- Ability to learn new skills and monitor performance for adherence to company procedures and policies.
- Detail oriented, able to work independently and work well in a team environment.
- Excellent proof-reading skills; ability to identify errors.
- Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs) and procedures.
- Demonstrated proficiency in the use of Microsoft Office Software (Word, Excel, PowerPoint, Access); Project and Visio a plus.
- Possess writing skills (grammar, spelling, organization of thought) and apply to communication and technical writing (investigations, etc.)
- Task completion skills.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.