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Description:
Executes batch record review
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
Participates in developing Standard Operating Procedures to ensure quality objectives are met.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Reviews routine manufacturing, environmental monitoring and quality control data for in process and finished products.
Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
participate in the writing of annual product reviews
participate in compilation of metrics (e.g. APR, QMR, etc…)
Normally receives very little instruction on routine work, general instructions on new assignments.
Interfaces with contract manufacturers to address documentation and compliance issues.
Perform other work as assigned
May participate in development of training programs regarding all aspects of producing quality products.
Facilitate training for BRR and FSP
May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
Performs Batch Record review and ATS functions, up to release of product
Facilitate EETs review and approval in GTrack, and Change Requests in Gvault; may also conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
Support changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
Conduct training for BRR qualification
Manage timelines and assign resources to review and perform product release
Manage CMO, inter-department, and cross-functional requests & communication
Participate in internal and CMO production meetings
Normally receives very little instructions on routine work, general instructions on new assignments.
Skills:
batch record review, Quality assurance, standard operating procedure, glp, gmp environment
Qualifications:
Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards
Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations
Demonstrates audit and investigation skills, and report writing skills.
Demonstrates strong verbal, technical writing and interpersonal skills.
Demonstrates proficiency
6+ years of relevant experience in a GMP environment related field and a BS or BA.
4+ years of relevant experience and a MS.
Prior experience in pharmaceutical industry is preferred.
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
