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JOB DESCRIPTION

ROLE: QA Specialist
SALARY: Negotiable
LOCATION: Ruislip
REPORTING TO: Quality Assurance Manager
HOURS: 9.00 – 18.00

The B&S Group is a privately owned pharmaceutical company which manufactures and distributes
pharmaceutical and healthcare products to the UK market. Established in 1999 we offer a wide range of
products and services which includes specials, generic drugs, branded medicines, parallel trade and over-
the-counter (OTC) medicines. Having undergone two acquisitions since 2010, we are continuing to
strengthen and grow.

We now require a QA Specialist to manage the QMS ensuring GMP compliance is maintained. You will also
be involved in internal audits and supporting external audits, as required.

DUTIES


For this position, your **key responsibilities ** will be:

 To ensure effective coordination of the QMS, including initiating investigations, root cause analysis,
risk assessments and implementation of Change Controls and Corrective and Preventive Actions as
appropriate.
 QMS data analysis and trending.
 Manage the internal audit programme and provide QA support during regulatory authority
inspections.
 Develop and maintain GxP standard operating procedures in accordance with regulatory and
company requirements.
 Provide oversight to external partners and vendors, including contract manufacturing organisations.
 To engage strong intradepartmental and cross-functional/organizational relationships to drive Quality
System Requirements.
 Update key performance indicators/metrics in a timely manner.
 Conduct supplier management activities including evaluation, approval, surveillance and audit where
necessary.
 Drive the site's continuous improvement activities and perform other related quality management
tasks.
 Any other task required from time to time to assist the efficient running of the Company's business.

SKILLS AND EXPERIENCE


 5+ year's QA experience within operational QA position in Pharmaceuticals

 Degree (or equivalent) in Science or related discipline.

 Broad knowledge of pharmaceutical industry regulations and guidelines


 Strong understanding of QMS- Deviations, change controls, CAPA, risk assessment etc.
 Ability to write and approve Standard Operating Procedures.
 Good time management skills
 Ability to work independently and with the multi-professional team
 Demonstrable ability to prioritise workload in order to meet deadlines
 Experience of working with CMOs is desirable.