With nearly a century of experience and innovation behind our name, Bellwyck Packaging Solutions is the first choice for health care packaging needs. We offer a seamless ‘one stop’ approach to pharmaceutical printed packaging and our clients value our strict cGMP and ISO compliance, lean manufacturing practices and ongoing research and development. We are looking for an outstanding Quality Assurance Manager to join our team in our Cincinnati facilities.
Responsibilities include assisting the QA Manager, Clinical Services in building the infrastructure and obtaining requisite licenses and client approvals for Bellwyck’s new stand-alone facility in Cincinnati, Ohio. Managing the transfer of activities from Patheon’s Reading and Blue Ash facilities to the Bellwyck premises in a GMP compliant manner. Responsible for ensuring the Cincinnati site is maintained in a state of compliance and QA training is delivered to all new employees when/as required. Leads regulatory and customer audits.
SKILLS, KNOWLEDGE / EXPERIENCE REQUIRED TO PERFORM THE JOB
- BS or equivalent, preferably in the field of science.
- 3 to 5 years’ experience in the pharmaceutical industry
- In-depth knowledge of cGMP
- Exceptional attention to detail and accuracy.
- Excellent organizational and time management skills.
- Effective interpersonal and teamwork skills.
- The ability to problem solve, coach as well as influence and negotiate at all levels within the organization.
- Extensive computer knowledge and adeptness with various software programs including database management.
- Mathematical and written/oral communication skill usually associated with completion of High School.
- Supports the QA Manager, Clinical Services in the achievement of organizational goals and objectives.
- Partners with the US Clinical Operations Manager in the delivery of Bellwyck’s services and products
- Ensures the site is maintained in a state of compliance, raising any issues or concerns to the QA Manager, Clinical Services.
- Develops new and revises existing Quality SOP’s and protocols researching best practices and regulatory compliance requirements.
- Manages Quality records, documentation and systems.
- Chairs regulatory and customer audits; investigates audit findings and undertakes corrective action where required.
- Performs customer and vendor audits undertaking any required follow up action.
- Facilitates the resolution of departmental issues.
- Directs the storage, production and release of raw materials and/or finished goods to ensure compliance with applicable provincial, federal, state as well as international cGMP regulations.
- Investigates Quality issues, deviations and or complaints ensuring appropriate resolution and corrective action is taken.
- Ensures all new employees are trained and general employee refresher training is conducted as required.
- Monitors to ensure 100% compliance to SOP’s.
- Reviews Batch Records for accuracy and completeness.
- Provides updates to the QA Manager, Clinical Services with respect to the trending or quality issues, discrepancies, non-conformances, de-segregations, etc.
- Initiates and executes improvements to the Quality Program.
- Assesses the capability and performance of Production employees with regards to compliance to QA processes and documentation requirements.
- Identifies training requirements; ensures employees are competent in their jobs.
- As requested, assists the US Clinical Operations Manager in the hiring and training of site employees.
- Partners with the QA Manager, Clinical Services and Human Resources on staffing needs, employee development, performance management issues, etc.
- Motivates employees: assesses performance; conducts coaching as well as disciplinary discussions; develops employee potential to the fullest
- Adheres to cGMP’s, SOP’s and Health and Safety practice.
- Other duties and projects as assigned.