Company: X4 Group
Closing Date: 09 Nov 16
Salary (£): 30,000 - 40,000
QA Specialist / Quality SpecialistPosition: QA SpecialistLocation: StaffordshireSalary: Competitive DOEA Staffordshire based Pharmaceutical Company are looking for a QA Specialist to join the team on a permanent basis. This is a great opportunity to join a young and vibrant team with lots of potential for career progression. ...
QA Specialist / Quality Specialist
Position: QA Specialist
Salary: Competitive DOE
A Staffordshire based Pharmaceutical Company are looking for a QA Specialist to join the team on a permanent basis. This is a great opportunity to join a young and vibrant team with lots of potential for career progression.
Reporting to the QA Manager you would be responsible for assisting the Quality Assurance Team, providing administrative, technical and quality support to the business in relation to Quality Assurance related matters, ensuring regulatory compliance and to investigate quality issues
Role and Responsibilities:
- To help ensure that the provisions of the company’s licences are observed
- To help ensure that the operations do not compromise the quality of medicines
- To assist with the management and maintenance of the Quality Management System
- To participate in both internal and external audit programs, and conduct audits as necessary (training for this will be provided)
- To ensure that appropriate standards of Good Distribution Practice (GDP) are maintained
- Liaise with the outsourced providers for both Medical Information and Pharmacovigilance to ensure an efficient service
- To support the development and implementation of regulatory and quality procedures
- Maintain the paper and electronic filing system regulatory and quality documentation
- To deal with both customers and suppliers at a technical level to investigate issues related to quality problems and customer complaints, which may be both sensitive and complex. This includes complaints and Corrective and Preventative Action (CAPA’s).
- Ensure that up to date copies of licences are held on file for all relevant Clients and Suppliers.
- To communicate relevant aspects of the quality system to employees, as necessary, in order to support product and service quality.
- To assist in providing training to members of staff on relevant components of Quality Management and Products
- To make decisions, solve problems and influence others, as necessary, in order to achieve the above responsibilities.
- To provide administrative support to the department for technical related activities
- Be involved in Client Audits and Competent Authority Inspections, including arrangement, participation throughout the audit/inspection and assistance in the follow up on any findings resulting from the audit.
- Life Sciences Graduate, Pharmacist or Chemist,
- Experience within a quality assurance role, or related
- The relevant provisions of the Medicines Act 1968 as amended and the Medicines for Human Use (Marketing Authorisations, Etc.) Regulations 1994 (SI 1994/3144) as amended.
- Falsified Medicines Directive (Directive 2011/62/EU)
- Directive 2010/84/EU in relation to Pharmacovigilance
- Directive 2001/83/EC as amended on the wholesale distribution of medicinal products for human use
- Official Guidelines on GDP of medicinal products for human use
- The conditions of the WL, MS, MIA(IMP) licence
- The products stored, distributed and provided under the licence and the conditions necessary for their safe storage and distribution
- The categories of persons to whom products may be distributed
- Ability to communicate at all levels.
- Ability to self-motivate and self-disciplined
- Excellent IT, planning, administrative and organisational skills.
- Solutions orientated
- Ability to be responsible and accountable
- Ability to change priorities and act urgently as and when required
- Excellent attention to detail
- Demonstrable business and commercial awareness
- Experience of working independently and as part of a team
- Trained as an internal/external auditor
- Ability to Travel is required for this role
A competitive salary is on offer for the right candidate!
Apply by sending your updated CV through to email@example.com and call Laura on 0207 812 7700 to discuss your application in further detail.
Pharma / Pharmaceutical / CAPA / GDP / Distribution / IMP / QA / Quality / Complaints / Audits / Deviations / Systems