Senior Quality Specialist
Endo Ventures Ltd.
Direct Reports (list)
Reports to (title)
Associate Director, Quality Operations
To be completed by Corporate Compensation:
FLSA (USA only)
Job Summary - a concise overview of the job
The Senior Quality Specialist is responsible for leading and 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 and leads 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 complex issues.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Support Quality activities for Endo Ventures Ltd.; no budget responsibility. Co-ordinate cross functional activities to meet operational needs. Works independently with minimal supervision, pro-actively problem-solve and implement solutions.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Quality Systems &
- Create GMP documents according to approved templates/procedures and managesthe change control approval cycle.
- Review and approve GMP documents received from contractors e.g. master batch records, analytical test methods, protocols etc.
- Manage issuance of required distribution copies of documents (internal and external) ensuring retrieval/destruction at obsolescence.
- Review 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 at contractors to ensure timely receipt of batch documentation and resolution of quality issues.
- Ensure assessments related to documents are current.
- Perform and support user training for Quality Systems.
- Perform and support GMP/ GDP training; provide training materials and/or conduct training sessions.
- Responsible for overseeing the complaints system.
- Receive & log complaints; gather information from call center and complainant; generate acknowledgement letter and send to complainant.
- Assess and evaluate the criticality of complaints, escalating those that may be a FAR.
- Provide notification and status of complaints to key stakeholders.
- Perform and support investigation of the complaint.
- Liaison with Endo Medical Information (EMI) and Pharmacovigilance & Risk Management (PVRM) and Safety on complaints/AEs.
- Follow complaint process through to resolution and generates/send close-out letter.
- Enter complaint data daily and maintains product complaint database and files.
- Serve as lead Quality Representative on process improvement initiatives.
- Performs gap analysis and recommends revisions to SOPs
- Collaborate with cross functional partners to identify and implement improvements.
- Track and provide metrics to management for areas of responsibility; notes trends and escalates to management.
- Ownership of portfolio of products.
- Author deviation/investigation reports for incidents which occur in area of responsibility.
- Participate in performing internal audits.
- Lead/Participates in resolving complex issues and helps drive root cause determination.
- Review / prepare annual product quality reports.
- Perform other duties as directed.
Lead/Support cross-functional and/or multi-site projects such as software evaluation, process presentations, etc.
- Respond to and escalate events identified as nonconformance.
- Perform periodic review of quality documents and update as necessary according to approved procedures.
- Train personnel on procedures and QS requirements; ensure adherence to SOPs related to areas of responsibility.
- Understand and stay current with regulatory guidance.
- Support site inspections/audits by providing requested documentation, act as SME for primary job functions, and act as scribe as needed.
- Follow all procedures to ensure a safe and compliant work environment.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- College degree in science related discipline.
- 5 + years prior relevant Pharmaceutical and/or Medical Device experience preferred.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- Strong knowledge of Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs).
- Knowledge of US and EU Regulations (ICH, EU GMPs, US CFRs, ISO, etc.).
- Knowledge of electronic data systems.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
- Detail oriented, able to work independently and work well in a team environment.
- Organise, prioritise, eliminate roadblocks and monitor work in the face of shifting demands and tight deadlines.
- Solve complex problems and exercise judgement.
- Communicate effectively with other departments, management and operational personnel.
- Customer/Stakeholder focused (understands impact of daily work to compliance and overall business).
- 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.
- Read and comprehend documentation and requirements set forth in Batch Production Records (BPRs) and procedures.
- Demonstrated proficiency in the use Microsoft Office software (Word, Excel, PowerPoint, Access); Project and Visio a plus.
- Possess writing skills (grammar, spelling, organization of thought) and apply to standard communication and technical writing (investigations, etc.).
- Good follow up skills to ensure task completion.
- Mentoring to less experienced co-workings.
- Evidence of regulatory compliance intelligence.
- Be able to identify non-compliant conditions using advanced quality recognition skills.
- Identifies, documents and recognizes solutions to quality issues and system improvements.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
- Ability to travel if needed (<5%).