Pharmaceutical Quality Assurance Manager

4 days a week
Hybrid working (2-3 days in Essex offices)
£50K pro rata (plus bonus)
 
Our client is a friendly, family-run business that owns 2 companies; a pharmaceutical and medical device company as well as a food supplement company. They purchase products in the UK and Europe and distribute globally.

They are looking for an experienced Pharmaceutical Quality Assurance Manager to join their team, reporting to the RP the ideal candidate will be an integral part to the business and will be expected to work quite autonomously across many aspects of the businesses.  This role has the opportunity to grow to a deputy RP role and cover when the RP is on leave.
 
Responsibilities with the pharmaceutical and medical devices company will include:
Management and monitoring of GDP compliance activities under Human Medicines Regulations 2012
Periodic management and review of change control system, CAPA system and Deviations/Notifications/Complaints master sheets
Manage and change SOPs for approval by RP(s) or RPI either periodically or where changes in processes.
Management and administration of a document control system
Management of a document archive
Performing supplier annual reverification procedures
Performance of Internal Audit on agreed GDP processes
Update Quality manual on an annual basis
Prepare data and information for, and participate fully in the fortnightly Management Meetings with Commercial and Finance staff
Present GDP refresher training to all employees and keep up to date with MHRA and GDP compliance changes
Investigation, resolution and management of customer complaints and insurance claims
Management and delivery of an internal audit system
Assisting in the audit of outsourced third party warehouse sites
Setting Quality KPIs for third party sites to improve performance
Management and Approval of Transport Carriers
Managing third party, supplier/customer and compliance MHRA and ISO audits
Understand the company’s goal and purpose so to continually enhance the Company’s performance.  
Responsibilities with the Food Supplement Business will include:
Review of laboratory test results for batch testing
Review of COAs per batch produced by contracted manufacturers.
Periodic management and review of CAPA system and Deviations/Notifications/Complaints master sheets
Creating processes for the Halal Monitoring Committee and Vegetarian Society audits where required
Collate registration documentation for overseas registration of products in new markets.
Management and administration of a document control system
Performing supplier audits
Investigation, resolution and management of customer product complaints
Assisting in the audit of outsourced third party warehouse sites
Managing remote audits from third parties including Halal, Vegetarian Society
Understand the company’s goal and purpose so to continually enhance the Company’s performance. The Ideal candidate will have:
At least 2 years experience in a similar pharmaceutical role and also have had covered the majority of the responsibilities
Proven GDP and food labelling standards knowledge.
A degree in Pharmacy or Chemistry.
Ability to work with different teams and train commercial staff on new processes
Significant experience in a QA role within the pharmaceutical industry supporting GDP & GMP activities.
Experience of managing Quality GDP and ISO audits
Delivers results on time, within constraints and in line with company policy and procedure and organisational strategy. Demonstrates a continuous drive for quality and a commitment to excellence.
Analyses and uses experience and logical methods to make sound decisions which solve difficult problems. Seeks practical/workable and innovative methods to deliver solutions.
Promotes a clear vision and mission. Acts as a positive role model for the organisation, fostering a climate of teamwork and development.
Communicates clearly and effectively. Promotes the exchange of ideas and information across the organisation. Fosters dialogue to ensure everyone understands what is going on.
Strives to exceed the expectations and requirements of internal and external customer; acts with customers in mind and values the importance of providing high-quality customer service.
Demonstrates required job knowledge and understanding to successfully and competently fulfill or exceed the requirements of their post. Follows correct procedures and guidelines (SOPs).
Proactively demonstrates a desire to enhance and develop their job knowledge.
Demonstrated Teamwork & Collaboration
Ability to prioritise and manage workload
Needs to be able to clearly demonstrate excellent knowledge of the current GDP standards and the way of working in the pharmaceutical industry  For more information and a confidential discussion, APPLY NOW