WORK EXPERIENCE AND EDUCATION REQUIREMENTS AND PREFERENCES:

1. Bachelor’s Degree or equivalent experience – Science related field preferred.
2. Minimum of 1–3 years of experience in pharmaceutical or biotechnology industry with quality systems exposure, preferably within a Quality role.
3. Strong technical writing skills with the ability to produce clear, concise, and GMP-compliant documentation.
4. Direct experience working with quality systems, particularly in deviation management, CAPA, or change control.
5. Experience drafting or editing quality records such as deviations, CAPAs, or SOPs.
6. Experience with electronic quality management systems (e.g., TrackWise, Master Control, Veeva, etc.).
7. Understanding of root cause analysis tools (e.g., 5 Whys, Fishbone, Fault Tree Analysis).
8. Familiarity with 21 CFR Part 210/211, ICH Q10, EU Annex 11, and data integrity principles (ALCOA+).
9. Knowledge of ICH Q9 risk management principles.

1. Review, assess, and approve deviations and CAPAs, ensuring alignment with regulatory expectations and internal SOPs.
2. Provide oversight of the deviation and CAPA programs, including tracking, trending, and periodic reporting of quality events.
3. Support cross-functional investigations by facilitating root cause analysis, assessing risk, and ensuring timely record closure.
4. Collaborate with Subject Matter Experts (SMEs) and operational teams to drive effective CAPAs and prevent recurrence of issues.
5. Interface with clients to escalate and discuss quality events, ensuring timely and professional resolution of concerns.
6. Provides support during internal, supplier, client, and regulatory audits by facilitating the staging and organization of required documentation.
7. Participate in audit response efforts and own quality records related to inspection commitments.
8. Contribute to monthly and quarterly quality metrics reporting and trending.
9. Write, review, and revise Standard Operating Procedures (SOPs) related to deviation and CAPA processes.
10. Represent QA in technical project meetings and provide quality input to cross-functional initiatives.
11. Review and approve maintenance records for GMP compliance.
12. Initiates and manages QA holds on materials and equipment to prevent unintended use pending investigation or resolution of quality events.
13. Supports the training of employees on deviation and CAPA processes, root cause analysis techniques, and technical writing to promote consistent and compliant documentation practices.
14. Perform other duties as assigned by the Supervisor in accordance with company guidelines and Standard Operating Procedures and appropriate industry regulations and guidelines.
15. Comply with Singota’s quality and safety management systems including requirements for documentation, training, system use, SOPs, processes, and procedures.