- Own, review and approve SOP’s and other GDP/GMP documentation and records (e.g. NCs and CAPAs), ensuring that Corporate, Site and Regulatory requirements are met.
- Lead and participate in ABR internal and external audits as needed.
- Support other company sites during European regulatory inspections by personal attendance as required.
- Maintain a close contact and familiarity with company Quality Systems and programs utilized at other company sites.
- Provide guidance and direction to quality, production, Warehouse/Distribution and Supply Chain staff in regards to compliance with quality policies, standards and procedures.
- Participate in global quality initiatives ensuring that ABR input is provided and leading ABR implementation activities.
- Act as QA contact for all activities related to new product introductions and product life cycle management, including but not limited to change control review and approval.
- Participate (lead) in various ABR projects and improvement efforts including (new) product launch teams.
- Act as owner for ABR quality programs and procedures
- Act as Quality contact in case of regulatory inspections or various questions from regulatory bodies.
- Perform activities as required per company procedures as QA staff, and in particular where the role of the QP is specified in the procedure.
- 8 years of professional experience in pharmaceutical environment (GMP)
- Relevant experience in dealing with Quality systems such as Non Conformances, CAPA’s, Change Control, Complaints, Internal and External audits.
- Relevant experience related to interaction with regulatory bodies, including but not limited to for example IGZ, EMA, FDA, etc..
- Effective communication skills at multiple levels and areas (inside and outside of Quality)
- Throrough decision making skills and ability to apply risk based approach.
- Familiar with risk management tools such as FMEA, etc.
- Decision quality
- Problem solving – making complex decisions
- Compliance rule-following attitude with high degree of attention to detail.