Quality Assurance Specialist

Responsibilities:

• Product quality & compliance with GXP; including appropriate reporting and escalation of any product quality or GXP incidents or non-compliance
• Escalation to management of any activities that potentially compromise the independence of the quality organization or the quality of the product;
• Completeness & accuracy of documents & records
• Approve OOS/OOE and laboratory deviation investigations and actions for QC, Microbiological and AS&T laboratories.
• Monitor, progress and follow-up corrective and preventative actions
• Assess events and their root cause, ensuring appropriate corrective and preventative actions
• Periodically report QC related KPIs
• Provide guidance to QC, Microbiological and AS&T laboratories on cGMP relevant queries
• Perform periodic checks of laboratory documentation and electronic systems i.e. QC data systems, laboratory books, logbooks
• Participate in root cause investigations
• Prepare and deliver overall quality related training programs
• Update/approve documents to ensure compliance with cGMP
• Participate in implementation of lab systems improvements
• Perform internal audits and gap analyses, where required
• Participate in internal/external audits
• Liaise with Support Group on equipment suitability, training, and lab improvements
• Provide QA oversight for method validation/method transfer

Requirements:

• Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
• Minimum 3 years’ experience working in the pharmaceutical industry in a Quality Role or a Production Role.
• Computer literacy (e.g. MS-project, Power Point, document management systems, databases) available and ability to quickly learn new software, tracking tools and associated processes.
• Experienced in influencing people, negotiation and communication skills
• Excellent organizational skills to drive projects with a proactive and action-oriented attitude
• Skilled at identifying and resolving areas of concern in relation to quality
• Good working knowledge of GMP regulations required within the pharmaceutical industry. Be able to impart this regulatory knowledge to site at all levels.
• Proven record of accomplishment of successfully working in interdisciplinary teams and of simultaneously planning, coordinating and/or leading activities on projects.