Sr. Quality Assurance Manager - Compliance
Company: Avion Pharmaceuticals
Posted on: August 7, 2022
Senior Quality Assurance Manager - ComplianceJob Description
The Senior Quality Assurance Manager - Compliance is responsible
for maintenance and oversight of the stability program, product
specifications, customer complaints, FAR reporting, recalls, and
approval of product labeling.Key Responsibilities/Essential
- Perform QA review and approval of Consumer Complaint
- Document and investigate clinical and commercial drug product
- Write, review, and revise Standard Operating Procedures (SOPs)
related to areas of responsibility, as necessary.
- Build a culture of continuous improvement to improve quality
behavior and sustain results.
- Plan the effective use of labor and materials, and lead teams
on special projects associated with the assigned area of
- Notify Senior Management of inspection observations, and
significant quality or compliance issues which may affect the
product or systems according to the requirement of the Management
- Provide oversight of the stability program and approve
appropriate retest/expiration dates to finished drug product
according to stability results.
- Review and approve stability reports.
- Review and approve all product labeling.
- Oversee the system to review, approve, and maintain product
- Ensure all events requiring FAR reporting's are communicated to
management and submitted to applicable regulatory authorities.
- Oversee the performance of recall activities.
- Basic Qualifications
- Bachelor's degree required; a Bachelor's degree in a scientific
or technical field, preferred.
- Minimum of 7 years of quality experience in a cGMP environment
required. 2 years experience managing pharmaceutical quality
- 2 years of progressive management responsibility, required.
- Thorough knowledge and understanding of cGMPs, FDA guidelines
and other regulatory agency requirements.
- Demonstrate strong critical thinking skills.
- Demonstrate leadership skills that include motivating others,
delegating, coaching and developing others in a team-oriented
- Proficient with Microsoft office applications.
- Ability to anticipate and resolve problems with minimum
negative impact on production, quality, safety, and cost.
- Strong interpersonal and communication skills (both written and
verbal) with all levels of management.
- Strong attention to detail.
Keywords: Avion Pharmaceuticals, Alpharetta , Sr. Quality Assurance Manager - Compliance, Executive , Alpharetta, Georgia
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