Medivant Healthcare
MGR QA-Manager of Quality Assurance
Medivant Healthcare, Chandler, Arizona, United States, 85249
Position Overview:
The
Quality Assurance Manager
will be responsible for managing day-to-day QA activities related to production support, documentation review, deviation investigation, and ensuring compliance with cGMP standards. This role serves as a critical link between production, quality control, and regulatory compliance teams to maintain the highest level of quality for all products manufactured.
Key Responsibilities: Manage
batch record reviews , ensuring accuracy and compliance prior to final product release. Oversee the handling and closure of
non-conformances ,
deviations , and
CAPAs
within defined timelines. Supervise
in-process quality checks
on the production floor to ensure adherence to SOPs and cGMP. Conduct
quality training sessions
for production and QA personnel. Participate in
internal audits
and support implementation of corrective and preventive actions. Assist in maintaining and updating
standard operating procedures (SOPs) , work instructions, and controlled documents. Monitor and report on
quality KPIs , such as deviation trends, document compliance, and audit readiness. Work with cross-functional teams (Production, QC, Engineering) to identify and mitigate compliance risks during manufacturing. Support validation and qualification activities related to facilities, utilities, equipment, and processes. Ensure
proper documentation and traceability
throughout the product lifecycle. Qualifications:
Bachelor's or master's degree in pharmacy, Chemistry, Life Sciences, or a related field. Minimum of
7-10 years of QA experience
in a pharmaceutical manufacturing environment (sterile injectables preferred). Sound knowledge of
FDA regulations ,
cGMP ,
ICH Q-series guidelines , and industry best practices. Experience in managing document control and batch record reviews. Strong attention to detail and analytical thinking. Effective team leadership, communication, and interpersonal skills.
The
Quality Assurance Manager
will be responsible for managing day-to-day QA activities related to production support, documentation review, deviation investigation, and ensuring compliance with cGMP standards. This role serves as a critical link between production, quality control, and regulatory compliance teams to maintain the highest level of quality for all products manufactured.
Key Responsibilities: Manage
batch record reviews , ensuring accuracy and compliance prior to final product release. Oversee the handling and closure of
non-conformances ,
deviations , and
CAPAs
within defined timelines. Supervise
in-process quality checks
on the production floor to ensure adherence to SOPs and cGMP. Conduct
quality training sessions
for production and QA personnel. Participate in
internal audits
and support implementation of corrective and preventive actions. Assist in maintaining and updating
standard operating procedures (SOPs) , work instructions, and controlled documents. Monitor and report on
quality KPIs , such as deviation trends, document compliance, and audit readiness. Work with cross-functional teams (Production, QC, Engineering) to identify and mitigate compliance risks during manufacturing. Support validation and qualification activities related to facilities, utilities, equipment, and processes. Ensure
proper documentation and traceability
throughout the product lifecycle. Qualifications:
Bachelor's or master's degree in pharmacy, Chemistry, Life Sciences, or a related field. Minimum of
7-10 years of QA experience
in a pharmaceutical manufacturing environment (sterile injectables preferred). Sound knowledge of
FDA regulations ,
cGMP ,
ICH Q-series guidelines , and industry best practices. Experience in managing document control and batch record reviews. Strong attention to detail and analytical thinking. Effective team leadership, communication, and interpersonal skills.