Objective:
Essential Job Duties:
• Creates a quality organization and systems that will provide Apicore with a competitive advantage in the market place• Provides effective leadership and direction for the quality programs throughout Apicore’s manufacturing operations on a global level• Provides structured review processes to report data on a monthly/quarterly basis to the CEO and Board of Directors• Directs efforts to ensure efficient and effective deviation, CAPA, training and document control systems are maintained and continuously improved• Serves as a key and active member of the team to ensure business objectives are aligned and that Apicore is performing to its operational objectives• Leads, influences, creates and works within cross-function team environments• Works on multiple projects simultaneously and adapts to fast-changing business priorities• All other duties as assigned
Experience & Education: Minimum Bachelor Degree Required. Experience in manufacturing and quality control experience with APIs and formulation.
Knowledge: Knowledge of cGMP (FDA/EU and ICH) requirements and the ability to assess compliance risks. Extensive experience in regulatory inspection management programs and participation in regulatory inspection audits.
Skills & Abilities:• Ability to work independently with little to no supervision • Excellent leadership skills• Exceptional oral and written communication capabilities• Advanced computer knowledge in MS Office programs• Excellent organizational abilities and superior attention to detail• Must have high level of interpersonal skills • Ability to maintain high level of confidentiality at all times• Possesses strong analytical and problem solving skills• Excellent time management skills and project management skills• May be required to sit, stand, walk regularly and lift, push, pull up to 50 pounds continuously
Working Conditions: Position will be mainly office and warehouse based with a clerical component in addition to physical requirements. Incumbent will be working in a laboratory and manufacturing facility and will be exposed to these environments. Minimal travel required.