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Quality Assurance (QA) Manager GMP (Full Time)

Location: Ohio Country: United States of America
 

Quality Assurance (QA) Manager with in-depth experience in small molecule drug substance development, manufacturing and characterization in compliance with GMP and GLP guidelines. Reporting to the General Manager, the QA Manager will provide Quality oversight and support to the Technical Operations group for the manufacture and characterization of non-clinical, clinical and commercial products in compliance with GMP and GLP guidelines. The QA Manager will be accountable for establishing and driving Quality initiatives, maintaining/improving quality infrastructure and participating where needed on various CMC related project teams. The QA Manager will be accountable for assuring compliance with Olon Ricerca Bioscience's Quality System, identifying/driving quality system improvement, quality oversight at the project level and generation of metrics to drive continuous improvement.

MAJOR ACTIVITIES AND RESPONSIBILITIES

Responsible for the review and approval of quality documentation including quality agreements, project protocols, validation plans, batch records and associated analytical data related to the manufacture and characterization of drug substances and drug products

Responsible for the disposition of drug substances and drug products

Review and approval of deviations and resulting investigation reports, corrective actions and/or preventive actions for adequacy and logic of root cause analysis, and impact to both quality and regulatory commitments.

Perform in-study and in-process audits to assure compliance of operational activities

Responsible for supplier and material qualification supporting GMP manufacturing,

Establish and administer program to assure data integrity

Administer Quality Management System databases for change control, deviations, and CAPAs

Management of a 3 to 5 person QA staff

Responsible for corporate archives and document control

Establish and administer corporate training program.

Manage inspections by Regulatory Authorities

Skills & Educational Requirements

BS or equivalent in a technical discipline and a minimum of 7-10 years of experience of in the pharmaceutical/biotech industry

Must have at least 5 years of experience in Quality Assurance supporting manufacturing and characterization of small molecule drug substance for clinical and commercial use in a contract environment.

Working knowledge and technical understanding of the manufacture and testing of small molecule drug substance and drug product

Knowledge of GMP and GLP principles with respect to FDA and EMA regulations and guidelines

Knowledge of drug development process

Experience in deviation investigations, root cause analysis, risk assessment and developing corrective action plans

Experience in data integrity/21CFR Part 11 Compliance

Experience is process validation, analytical method validation and equipment qualification

Excellent communication and documentation skills

Experience managing multiple priorities and quality assurance staff 

Olon Ricerca Bioscience LLC. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.


Posted Date: 11 Feb 2020 Reference: CB Company: OlonRicerca Bioscience Contact: Bernadette Armbruster