CAPA Specialist

Job Title:

CAPA Specialist

Job Description

The CAPA Specialist is responsible for driving the effective closure of Corrective and Preventive Actions (CAPAs) associated with deviations, investigations, and non-conformances within pharmaceutical packaging and aseptic filling operations. This role ensures that all activities comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality systems, while supporting a highly regulated production environment. The position requires strong cross-functional collaboration with Quality Assurance, Manufacturing, Engineering, and Technical Writing teams to achieve timely, compliant, and sustainable CAPA resolution.

Responsibilities

+ Lead and coordinate CAPA closure activities related to pharmaceutical packaging and aseptic filling operations.

+ Ensure CAPAs are completed in alignment with defined timelines, quality standards, and regulatory expectations.

+ Verify completion and effectiveness of corrective and preventive actions prior to CAPA closure.

+ Conduct follow-ups to confirm sustained resolution of identified root causes and prevent recurrence.

+ Review deviation investigations tied to packaging and filling processes to ensure accurate root cause identification.

+ Support or perform root cause analysis using tools such as 5 Whys, Fishbone diagrams, and risk assessment methodologies.

+ Ensure all investigation and CAPA documentation clearly supports CAPA effectiveness and closure rationale.

+ Review and update Standard Operating Procedures (SOPs), batch records, and associated documentation as part of CAPA execution.

+ Ensure all documentation meets cGMP, FDA, and internal quality system requirements.

+ Maintain accurate, complete, and audit-ready CAPA records within electronic quality systems such as Track Wise, Veeva, or Master Control.

+ Partner with Manufacturing teams to address process gaps in packaging and filling operations, including equipment operation, HMI use, and inspection processes.

+ Work with Quality Assurance to support batch record review, lot release readiness, and compliance verification.

+ Collaborate with Engineering on process improvements, equipment changes, and validation activities related to CAPAs.

+ Perform CAPA effectiveness checks and trend analysis to identify recurring issues and systemic problems.

+ Recommend process improvements and preventive measures to reduce deviations and enhance operational efficiency.

+ Support continuous improvement initiatives such as Lean, Kaizen, and risk reduction programs.

+ Contribute to remediation efforts and CAPA programs focused on resolving quality and compliance gaps.

+ Engage in investigations related to customer complaints and deviations, ensuring appropriate CAPA actions are implemented.

Essential Skills

+ Bachelors degree in Life Sciences, Engineering, or a related field.

+ At least 3 years of experience in pharmaceutical manufacturing, preferably in packaging or aseptic filling environments.

+ Demonstrated experience managing or closing CAPAs within a regulated cGMP/FDA environment.

+ Strong understanding of deviation investigations, root cause analysis, and quality systems.

+ Previous pharmaceutical GMP experience with filling and packaging operations.

+ Hands-on CAPA closure experience, including verification of effectiveness and documentation of closure rationale.

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Experience with investigations, including customer complaints and deviation-related root cause analysis.

+ Proficiency using electronic quality management systems, particularly Track Wise, and familiarity with other systems such as Veeva or Master Control.

+ Ability to review and update SOPs, batch records, and other technical documentation in a clear and compliant manner.

+ Strong attention to detail and ability to maintain accurate, audit-ready records.

+ Effective communication and collaboration skills for working with Quality Assurance, Manufacturing, Engineering, and Technical Writing teams.

Additional

Skills & Qualifications

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Experience with injectable or sterile drug product packaging and filling operations.

+ Familiarity with validation activities, including IQ, OQ, and PQ, and related change control processes.

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Experience with batch record review and support of lot release readiness.

+ Technical writing or documentation experience, particularly in drafting and revising SOPs and batch records.

+ Exposure to remediation projects focused on improving quality systems and closing large volumes of CAPAs.

+ Experience…