QA Release Senior Quality Reviewer

About the job

This role provides quality oversight of the Batch Release Protocol (BRP) process and final release to market. This role will perform final review and approval of all batch release protocols for both foreign and domestic submissions.

Main Responsibilities

• Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements
• Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)
• Reviewing and performing final approval of batch release protocols
• Perform final approval of batch release protocol product configurations
• Coordinate with supply chain and regulatory affairs to schedule batch release protocols and priorities
• Perform ship approval for batches destined for international countries
• Fostering a culture of quality and continuous improvement across the organization
• Participating in internal and external audits and regulatory inspections providing support and documentation
• Investigating and resolving any issues or deviations related to batch release (including temperature excursion evaluation per product if distribution channel faces an unusual event)
• Collaborating with regulatory affairs to ensure compliance with local and international regulations
• Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness
• Participating in Quality Alert/Product Alert meetings and ensuring that investigation and actions taken during those meetings allow the decision for disposition of lots
• Perform any other tasks assigned by Manager

Key Involvement in Decision Making

• Prioritize quality and compliance objectives (D)
• Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D)
• Check whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D)
• Review and approve documentation for batch disposition (A)
• Release of all stages of batches, focusing on the formulation, master/fill/inspect, and packaged stages
• Advise on initiatives to promote a quality-focused culture (A)
• Advise on how to present a topic and answer specific questions (A)

About You

Basic Qualifications

• Bachelor's degree
• 3+ years of experience in Quality Assurance within the pharmaceutical industry
• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles

Technical Skills

• Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards
• Capability to investigate and resolve issues or deviations related to batch release processes efficiently
• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards
• Strong Computer Literacy (including Microsoft excel, power point, word)

Soft Skills

• Ability to analyze complex data and identify trends, issues, and solutions
• High level of accuracy and attention to detail in all quality assurance activities
• Proficiency in identifying problems and implementing effective corrective actions
• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
• High level of autonomy