Michael Parker at skills alliance is recruiting a Senior QC Operative. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.
To be efficient in processing the work within the QC Department. Have a good knowledge of and always adhere to the company’s Standard Operating Procedures and comply with both Good Manufacturing Practice and Good Distribution Practice at all times. To comply with all company Health & Safety Policies, Procedures, Work Practices ensuring accuracy and quality and any other Health & Safety requirements at all times.
Duties and Responsibilities:
- Review and inspect incoming EU deliveries to verify the consignment has been received in an acceptable condition with no visible damages, indication of tampering, and that it is from an approved active supplier. The consignment was shipped securely under acceptable environmental conditions by an approved transport provider. Any products requiring special or secure storage requirements (temperature sensitive stock or controlled drugs) are processed in a timely manner and transferred to the appropriate location.
- Record all relevant details of deliveries received on the company system.
- Performing identity checks on raw product and reporting any discrepancies with the associated specification.
- Ensuring all checks are recorded accurately during identification check.
- Ensuring photographs of raw product are taken showing all faces (outer and inner) with batch number, expiry date and EU/ECMA visible and attached to batch documentation.
- Ensuring all Italian sourced consignments undergo a Bollino authenticity check.
- Ensuring all Greek sourced stock undergoes a Vignette authenticity check.
- In process checks during production.
- Performing a line clearance prior to and post QC final verification checks and completing the line clearance logbook accordingly.
- Ensuring all relevant documentation is present with the working BPR and confirmed as complete.
- Inspect materials or products being produced and recording outcomes in the relevant documentation.
- Compering materials or products against a pre-defined standard specification.
- Approving or rejecting components, packaging materials and finished products.
- Ensure that if errors occurred, that they have been reported.
- Check performs on the pre-printed packaging materials:
- Removing and checking number of samples specified in the sampling plan for packaging material (number of samples is determined by QA personnel).
- Escalating any quality defects to the QA who will assess the conformance or non-conformance of packaging material.
- Performing identification check on the random sample that represents the batch; if any discrepancies related to the starting material or/and finished product found at this point, QC quarantines the whole unit.
- Reviewing the batch records and ensuring all entries are inserted accurately.
Support QC Manager:
- Ensuring QC staff always comply with the applicable GMP requirements and associated processes and procedures.
- Reporting any errors/non-compliances as quality incidents. Ensuring the details of any events or deviations raised are accurately recorded in the applicable controlled document (including the corresponding references).
- Informing the operations manager of product related quality incidents as soon as possible.
- Escalating any issues or concerns to The Quality Director, GMP QA Manager or RP.
- Provide advice to staff regarding the quality standards.
- Monitor operations to ensure compliance with quality standards.
- Providing assistance to production staff where necessary regarding the quality standards.
- Ensuring all retention samples are stored securely.
- Ensuring all completed and signed batch records are stored securely.
- Monitoring retention periods for batch documentation and retention samples.
This is an urgent role so please get in touch as soon as possible if you are interested.