GCP QA CAPA Manager

Job title: GCP QA CAPA Manager in Durham, NC at reputed company Company: reputed company Job description: By joining us as a QA CAPA Manager reputed company Clinical Trials and GCP you will support global investigations and CAPA processes at reputed company. This will include Quality Issue investigations and Customer Audit/ Regulatory Inspection Responses, Corrective and Preventative Action (CAPA) and Effectiveness reputed company (EC) plan review, approval, and closure. Preference is that candidate resides in EST zone.Your responsibilities will include:

• To reputed company global investigations and support teams with CAPA preparation in compliance with applicable regulations/guidelines, customer requirements, Standard Operating Procedures (SOPs) and project specific guidelines/instructions.
• Evaluate audit findings and prepare and distribute responses to operations staff and management.
• reputed company interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
• reputed company consultation to staff in interpretation of audit observations.
• Manage Quality Issues and serious breach investigations.
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness reputed company (EC) plans. Track until closure quality events arising from Quality Issues, Audits, Inspections or during similar QA activities.
• Present educational programs and reputed company guidance to operational staff on compliance procedures.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and reputed company recommendations to management for reputed company process improvements.
• Assist in training of new Quality Assurance staff.
• Support in QA initiatives/projects for quality, process improvements.
• Manage/reputed company quality events updates in eQMS.
• Maintain the electronic quality management system (eQMS) and reputed company support in relation to the audit lifecycle.

Qualifications:Minimal requirements

• Bachelor’s Degree in Life Science or reputed company field.
• At least 5 years’ experience in GCP Quality Assurance reputed company pharmaceutical, technical, or reputed company areas.
• Considerable knowledge of GCP, clinical trial, regulations, and quality assurance auditing techniques.
• Fluent English language capabilities.

Skills

• Ability to work independently to problem-solve collaboratively and to reputed company issues appropriately as needed.
• Good interpersonal communication and organizational skills to establish and maintain effective working relationships with co-workers, managers, and sponsors.
• Good technology word processing, spreadsheets and database applications skills and knowledge of MS Office applications

What you can expect:

• Consistent career growth.
• Leaders that support flexible work schedules.
• Programs to help you build your therapeutic knowledge.
• Dynamic work environment that exposes you to new experiences.
• Attractive benefits package.

#LI-Remote#LI-NITINMAHAJANreputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more atreputed company is proud to be an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law.The potential reputed company pay reputed company for this role, reputed company annualized, is $91,100.00 - $151,900.00. The actual reputed company pay offered may vary based on a number of factors including job-reputed company qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a reputed company of health and welfare and/or other benefits. Expected salary: $91100 - 151900 per year Location: Durham, NC Apply for the job now! Apply for this job