Qualified Person (QP)

JR United Kingdom; Scotland; Hybrid; GBP 40,000 - 70,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking an experienced Qualified Person (QP) to join their team during an exciting period of expansion. This permanent role offers hybrid working options and the opportunity to ensure compliance with regulatory directives while maintaining product quality standards.

Qualifications

• Eligible to undertake duties of a Qualified Person.
• Experience with regulatory agencies like FDA, MHRA, EMA.
• Prior experience in pharmaceutical manufacturing environment.

Responsibilities

• Undertake duties of a Qualified Person as per regulatory directives.
• Responsible for Batch Certification and Release of drug products.
• Ensure compliance with Good Manufacturing Practice (cGMP).

Skills

Regulatory Compliance

Good Manufacturing Practice (cGMP)

Quality Management Systems

Collaboration

Subject Matter Expert (SME)

Education

Degree in Chemistry, Pharmacy, Biological Science

Job description

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SRG's client is looking for an experienced Qualified Person (QP) to join them on a permanent basis during an exciting period of business expansion.

This role offers a fantastic opportunity for an experienced QP to secure a permanent position with excellent salary and benefits.

Hybrid working options are available.

The Role:

1. Undertake the duties of a Qualified Person as defined in relevant regulatory directives.
2. Responsible for the Batch Certification and Release of drug products in accordance with EU Directives and GMP requirements.
3. Ensure products are manufactured and tested following Good Manufacturing Practice (cGMP).
4. Verify that manufactured products comply with regulatory requirements.
5. Collaborate with the Quality Director and site management to ensure GMP compliance, adhering to legislation, company policies, and manufacturing authorizations.
6. Review and implement Quality Management Systems in line with current GMP and regulatory updates, maintaining product quality and release standards.
7. Act as a Subject Matter Expert (SME) to support site compliance with Quality Management Systems, including internal audits and regulatory inspections.
8. Perform external audits and support the company's self-inspection schedule, staying updated with current guidelines and regulatory developments for ongoing professional growth.

The Person:

1. Eligible to undertake the duties of a Qualified Person.
2. A relevant degree in Chemistry, Pharmacy, Biological Science, or related fields.
3. Experience with regulatory agencies such as FDA, MHRA, EMA.
4. Prior experience in a pharmaceutical manufacturing environment.
5. Experience with both commercial and Investigational Medicinal Products (IMP).
6. Experience in sterile products, biologics, especially with advanced therapeutics and licensing for these products.
7. Willingness and ability to travel for audits (occasional).