Quality Compliance Specialist
International Pharmaceutical Manufacturer requires a Quality Compliance Specialist (QA Audit).
Duties may include:
- To write and review Technical and Quality Agreements to ensure the company has defined responsibilities and robust systems in place with suppliers and service suppliers.
- To review and respond to customer and third-party audit and self-assessment questionnaires.
- To perform internal audits and provide feedback to the Quality Audit Manager on the GMP Compliance of systems and Processes. Identify gaps and facilitate improvements to systems and processes to ensure adherence to current GMP guidelines.
- To perform Supplier audits and provide feedback to the Quality Audit Manager on the compliance of suppliers and service providers with respect to regulatory requirements and quality agreements and specifications. To identify gaps, communicate any observations noted and review responses so that a positive working relationship with suppliers and service providers is maintained.
- To ensure activities meet the requirements of current GMP and GLP regulations by reviewing updates to Pharmacopeial and GMP requirements. To communicate updates to the appropriate departments.
- To review media fills, start pool records and plasma incidents in order to be able to effectively liase with regulatory agencies (e.g MHRA, FDA and NIBSC). To be a point of contact within the Quality Department for media fills and plasma related queries.
Skills and experience
- 5 years-experience in a similar role
- A Scientific degree
- A good knowledge and understanding of EU GMP and US CFR regulations and guidelines
- A good working knowledge of the EU and US Pharmacopeias
- Qualifications and/or experience in performing internal and external audits, ideally to GMP and ISO9001 standards.
- Experience in planning and taking part in regulatory inspections
- An understanding of current GMP issues affecting both pharmaceutical and sterile pharmaceutical product manufacture.
This job was originally posted as www.totaljobs.com/job/86436673