Quality Assurance Operations Compliance Executive

3 months ago

Watford, United Kingdom Sigma Pharmaceuticals Full time

Sigma is a family-owned and family-run business, which has been serving Independent Pharmacies, Dispensing Doctors, and Hospitals for over 40 years. Being one of the largest independent pharmacy wholesalers in the UK meeting the independent needs of customers is at our heart.

We are currently seeking a Quality Assurance Operations Compliance Executive who will support and assist the Operations department on Good Distribution Practice (GDP) compliance and act as primary bridge between the QA department and Sigma operations department.

We are seeking someone with previous QA experience knowledge and understanding of GDP/GMP within a distribution environment.

**Responsibilities**
- Ensure all quality documentation is issued and controlled appropriately
- Updating, maintaining and distribution of Standard Operating Procedures.
- Updating and maintaining all QA tracking tools / logs
- Assisting with Self-Inspections
- Assisting with investigation into deviations and ensuring CAPAs are implemented in a timely manner and effectively.
- Logging internal complaints
- Assisting with product recalls
- To perform and report any observations for the following scheduled tasks

**Goods In**
- Check if all MHRA Notice Boards (Recalls/Stolen notifications) are up to date.
- Appropriate segregation of products (Quarantine/Destruction/Controlled Drugs/ Unchecked Goods & Checks Goods)
- Pallets labelled accordingly to it's status.
- Support Goods In Department regarding queries for incoming goods (including physical checks) and filling Suspected Goods Form (where required)
- Spot Checks on Goods In Check Note (ALCOA Principles)
- Observe the usage of blankets during adverse weather conditions while unloading.

**Goods Out**
- Consignments ready to be dispatched stored in the dedicated area.
- Appropriate labels regarding number of pallets & temperature labels
- Spot-Check medicinal products with expiry date near 3 and 6 months at the last working day of the month.
- Check the use of coloured Tape (Red & Blue).

**Premises & Facilities**
- Check if all Pest Baits location matches Floor Plan
- Check if all Temperature Sensors are located according to EMS Floor Plan
- Assist Operations Facilities Department regarding Maintenance Log & Equipment List (All sites)
- Support Operations Department regarding Qualification and Validation of Equipment’s (All sites)
- Observe Warehouse Cleanliness and check against Cleaning Reports
- Support on the investigation of temperature alarms
- Checks CD Vaults Staff Entry Records
- Check that if only IPPC Pallets are being used

**Transport**
- Inter-Depot Transfer following ALCOA principles
- Checking Sigma South Cross Docking and Returns Sheet
- Spot-Check Sigma Vehicles (Temperatures, Cleanliness, Vehicles Checks sheet and the usage of curtains).
- Spot-Check Transport Delivery sheets & Vehicle Checks (ALCOA)

**Returns**
- Spot-check Drivers returns paperwork (ALCOA) and Authorisation Return Notification
- Confirm segregation of recall products returned by Customers.

**Miscellaneous**
- To comply with Health and Safety Regulations
- To maintain the confidentiality of all information relating to the business activities of the companies mentioned.
- Attend relevant training courses as required by the Company.
- To perform other duties as directed by the Company.

**Job Types**: Full-time, Permanent

**Salary**: £35,000.00-£40,000.00 per year

**Benefits**:

- Bereavement leave
- Canteen
- Company events
- Company pension
- Employee discount
- Enhanced maternity leave
- Enhanced paternity leave
- Free parking
- Health & wellbeing programme
- Store discount

Schedule:

- Monday to Friday

Work Location: In person

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