Job Description
Your new company
At SFI Health, we believe we have the responsibility to bring proven natural health solutions to people’s healthcare needs. We are a global natural health company committed to sourcing and producing natural medicines to the highest standards. Backed by evidence of effectiveness, quality and safety, our products are marketed around the world using our international community of leading life sciences companies and distributor networks.
To find out more, please visit https://www.sfihealth.com/
Your new role
As a Quality Assurance Officer at SFI Health, Wigan, you will play a key role in supporting both business operations and regulatory compliance. You will be responsible for maintaining our Pharmaceutical Quality Management System (PQMS) and ensuring that all quality processes, standards, and controls are consistently applied across the site.
Key responsibilities and accountabilities:
* GMP Documentation maintenance, review, and approval (Batch Records, Protocols, Reports, Standard Operating Procedures etc.)
* Organization and verification of supporting documents for raw materials.
* Development, registration, and maintenance of Regulatory Compliance (Deficiency Letters, specific tasks, requests from the authorities) in collaboration with Regulatory Dept.
* Assistance with HACCP team activities and related documentation.
* Regulatory audits and preparation and updating of the documentation required by the Quality System
* Implementation of the site’s GMP projects
* Customer and Supplier management and approval, including Quality Agreements
* Data integrity
* External audits: GMP audit preparation with suppliers and producers of raw materials, contracting of bulk products.
* Preparation, review and execution of Process validation and cleaning validation protocol / reports
* Deviation and OOS investigations including Root Cause Analysis
* Self-inspection support and management
* Change Control management.
* Training system Management
* GMP technical instruction to Operations staff
* Batch record review and management of all the activities for the release of products in a timely manner.
* CAPA, non-conformances and complaints management
* Qualification & validation activities
* Review and approval of SOP and Quality documents in co-operation with the QA team.
* Support all activities pertaining to the effective running of the Quality Management System
* Support the site to maintain a compliant facility.
Qualifications:
* Educated to degree level in a relevant scientific subject (or sufficient length of relevant experience)
* Experience of working in a GMP pharmaceutical and / or food manufacturing environment
* Experience working with Quality Management Systems
* Previous use of Trackwise and SAP systems preferred.
Experience:
* Minimum 2 years of experience in pharmaceutical regulatory affairs, healthcare compliance, or related roles.
* Strong knowledge of GMP, regulatory compliance, and quality systems.
* Excellent attention to detail, organizational skills, and collaborative working.
* Strong communication and documentation skills
Job Skills:
* Ability to maintain and review quality records accurately.
* Attention to detail and high level of accuracy in all QA tasks.
* Excellent analytical and problem-solving skills
* Proficiency in Microsoft Office and QA-related software/tools
* Strong communication and interpersonal skills for collaborating with cross-functional teams.
* Ability to prioritize tasks and manage time effectively.
* Understanding of continuous improvement and quality processes
Benefits, Perks:
* Supportive work culture
* Company pension
* Flexitime
* Referral programme incentives
* Company sick pay
* Birthday holiday
* Long service bonus
* Company performance-based bonus
* Access to LinkedIn Learning
* Reward & recognition programme.
Additional Info:
You will be part of many activities and celebrations, working with diverse cultures in a growing organisation.
Schedule:
* Day shift
* Monday to Friday
How To Apply
Apply now with your resume and cover letter detailing your relevant experience and why you are the perfect fit for this role.
We thank you in advance for your interest in this position, however, only shortlisted candidates will be contacted for an interview.