RAQA Specialist Pharma

We are looking for a Pharma RAQA Specialist to be part of the global pharmaceutical RAQA team, supporting licensed pharmaceuticals in USA, UK, and the EU.  In addition, the role will work closely with the Rayner QA department as a quality advocate and will act as the Rayner US Responsible Person appointed for the Rayner's device warehouse in support of the Prescription Medical Device range.

You will be responsible for:

• Ensuring compliance with the requirements of medical device and applicable medicinal regulations and Rayner's QMS,
• Communication between the FDA and the manufacturing company, including the receipt of information related to inspections and audits, and participating in audits,
• Supporting product recalls of medical devices or pharmaceuticals,
• Ensuring compliance with FDA regulations and procedures required for importing products,
• Ensuring vendor approval, oversight and management of key external stakeholders (e.g. CMO's, 3PL, wholesalers, test houses, etc.), including participation in auditing suppliers,
• Ensuring the product dossiers are current and maintained to support the compliance activities of Rayner's Medicinal products, including on Life Cycle,
• Compilation of data, analysis and results for KPI,
• Reviewing executed pharmaceutical batch production records to ensure compliance with registered specifications, approved procedures and GMP expectations, ensuring Rayner's pharmaceutical products remain available to customers,
• Reviewing and documenting of external parties' and internal records; change controls, deviations (OOS/OOT), validation documentation, stability data and CAPA's,
• Participation in the management of customer complaints,
• Performing Internal audits of Rayner's QMS as required and participation in the Inspection readiness program,
• Participating in the PRC process ensure promotional and marketing materials are reviewed in conjunction with marketing, legal and medical teams,
• Drafting QMS documents (SOPs, etc.), and
• Other duties as required.

Competencies

• Communication: communicates effectively, listens sensitively, adapts communication to audience and fosters effective communication with others
• Compliance: conforms to company policies and procedures
• Decisiveness: immediate responsiveness, and the ability to handle critical situations, such as inspections or emergencies.
• External Awareness: understands and keeps up to date on local, national, and international policies and trends that affect the organization
• Flexibility: modifies his or her approach to achieve a goal. Is open to change and new information; rapidly adapts to new information, changing conditions, or unexpected obstacles
• Teamwork: maintains positive relationships with management, external parties and peers.
• Organizational awareness: meeting, within a demanding environment, strict timelines and protocols

Qualifications/ Training/Experience

Essential

• Lead Auditor qualified In Title 21 CFR Parts 210 & 211
• Either: o Bachelor’s Degree, preferably in Pharmaceutical Science or related field, or o Minimum of 5 years of experience In Quality Assurance or related area
• In-depth knowledge and experience with GMP, Industry standards (ISO, USP, ICH, FDA) and understanding of PIC's
• Attention to details, as well as the ability to adapt quickly to changing regulations. * Computer literate
• Workload and schedule management skills
• Experienced In the presentation of situation and data

Desirable

• Experience within the Ophthalmology sector
• Experience in the manufacture of sterile or aseptic manufacture
• Internal auditor for ISO 13485/MDSAP would be an advantage

What you can expect from us: 

• • Comprehensive benefits package
  • Global appreciation platform to recognise colleagues around the globe
  • Fantastic opportunity to work with highly talents teams and individuals and grow with the business
  • Being part of an organisation you can be proud to work for changing the lives of millions of people!

  Rayner provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.