QMS Officer

QA/QMS Officer, Pharmaceutical
Location: Bolton/ North Manchester area
Type: Permanent
Salary: £24,500 - £27,000 DOE
Hours: Days (Monday - Friday), parking onsite
Our Client a Pharmaceutical company (part of a large Pharmaceutical group); is looking to strengthen their QA team and recruit an experienced QA Specialist. This is a GDP focused position and this person will play a key part in the growth and development of the team.
The role:
• Batch release of manufactured products and Release of Third Party products or Products (when covering due to staff shortages)
• Generation or review of SOPs and other documents (where applicable)
• Providing support the customers and answering queries and product investigations
• Coordinate and resolve immediate/urgent customer complaints, ensuring prompt responses/ resolution
• Participate in the internal audit programme to ensure continued GMP compliance of all site activities
• Utilise scientific resources in order to work on improving quality of products and services
• To maintain personal training folder in an auditable state
• To undertake any task required by your Line manager, and for which you have received full training and or an explanation has been provided and understood
• Generate new BMRs and offer technical assistance in product manufacturing as and when required (when covering staff shortages)
• Respond to external and internal medicines information requests
• Maintaining quality documentation system
• Participate in quality improvement initiatives
• Supporting in the process or maintaining and archiving documentation
• Supporting and executing external audits where applicable
• Supporting management when hosting regulatory audits
• Ensuring training matrix is maintained site-wide
• Generating worksheets and reviewing QC and R&D documents
• Maintaining records of MHRA drug alerts and assessments
• Supporting in generation of Quality Metric reports and tracking KPIs
• Working on executing and maintaining the QMS, including but not limited to:
oRisk Assessments
oChange Controls
oCAPAs
oDeviations
oComplaints
oRecalls
oOOS/OOT
The Person:
• Will have a Degree in a relevant- Scientific discipline
• Will have good knowledge of GMP
• Experience in CAPA, Deviations, OOS, OOT, Internal auditing (preferred), Customer Complaints handling would be very advantageous
• Strong IT skills (Microsoft applications)
• Good interpersonal skills and strong written/ verbal report writing skills
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