Respomsible Person Gdp

1 week ago

London, United Kingdom Propharma-UK Full time

Job Overview:We are currently seeking a Responsible Person GDP to join our team.

Must have GDP training completed and evidenced within the last 12 months.
- Maintain accurate records of all distribution activities
- Implement and maintain quality systems and procedures in line with GDP guidelines
- Ensure all staff involved in distribution activities are appropriately trained and qualified
- Handle any GDP-related deviations or complaints effectively
- Liaise with regulatory authorities on GDP mattersExperience:

- Previous experience in a similar role within the pharmaceutical industry
- In-depth knowledge of GDP regulations and requirements
- Strong communication and negotiation skills
- Excellent organisational abilities and attention to detail
- Ability to work effectively in a fast-paced environment
- Proven track record of maintaining high standards of compliance with regulatory requirements
- Key Responsibilities:_
- **Regulatory Compliance**: Fulfil the responsibilities of a RP as defined under the Wholesale Dealer’s Authorisation (WDA). Act as the primary contact with the Medicines and Healthcare products Regulatory Agency (MHRA)
- **Quality Management System (QMS)**: Ensure a robust QMS is implemented and maintained across all company operations
- **Record Management**: Oversee the management of authorised activities and ensure the accuracy and quality of records
- **Documentation**: Support the creation, revision, and approval of written procedures and other regulatory compliance documents
- **Training**: Ensure that initial and continuous training programs are implemented and maintained
- **Supplier and Customer Approval**: Ensure that all suppliers and customers are approved
- **Controlled Drugs**: Ensure legal requirements for handling controlled drugs (narcotics) are complied with
- **Quality Management Reviews**: Chair periodic Quality Management Review Meetings and lead process improvement initiatives
- **Subcontracting**: Approve any subcontracted activities impacting GDP
- **Internal Audits**: Ensure self-inspections (internal audits) are performed at appropriate regular intervals, following a prearranged program, and that necessary corrective measures are put in place
- **Recall Operations**: Coordinate and promptly perform any recall operations for medicinal products
- **Complaint Management**: Ensure effective handling of customer complaints
- **Product Disposition**: Decide on the final disposition of returned, rejected, recalled, or falsified products
- **Compliance with National Laws**: Ensure adherence to additional national requirements for specific products as per Article 83 of Directive 2001/83/EC

You will have a keen eye for detail and a strong commitment to regulatory compliance as well as:

- A degree in Pharmacy, Life Sciences, or a related field with a **minimum of 3 years** in a similar role within the pharmaceutical industry
- An understanding of MHRA Good Distribution Practices (GDP) and relevant certifications in quality management, regulatory affairs, or related fields
- Strong leadership, communication, and organisational skills, with proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) at an intermediate level.

Contract length: 12 months

Pay: £40,000.00-£60,000.00 per year

**Benefits**:

- Company pension
- Flexitime
- On-site parking
- Work from home

Schedule:

- Monday to Friday

Work Location: In person

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