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Date Added: Wed 01/11/2023

Qualified Person

Manchester, M1, UK
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Company: SKC RECRUITMENT LTD

Job Type: Permanent, FullTime

Salary: £70000 - £80000/annum

Role: Qualified Person

Brief Role Description:

Perform QP batch release and support with the day-to-day operation of the Quality Management System. Perform QP batch certification and meet QP duties as per Annex 16.
Work closely with the QA team to ensure effective functioning of the Pharmaceutical Quality System.

Key Responsibilities :

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Carry out the duties as described in the QP Code of Practice and Eudralex 4 GMP guideline for QPs (Annex 16)

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Undertaking and performing all Qualified Person (QP) activities ensuring adherence to the site's

Manufacturing Licence (MIA) and PLPI Marketing Authorisations.

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Timely QP certification for release of all products

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Reviewing and approving Standard Operating Procedures and other relevant GMP documents relating to

the manufacture, labelling and assembly operation, storage, and distribution of medicinal products

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Support deviations, CAPA, change control, complaints, recalls, risk assessments, re-works and adverse events

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Providing support to Regulatory Affairs

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Undertaking relevant project work as required, involving improvement of QA systems and processes

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Provide training to Maxearn personnel, where required

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To undertake routine product certification as a Qualified Person in accordance with article 51 of 2001/83/EC and Annex 16 of Good Manufacturing Practice Part I (EudraLex volume 4)

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Assist and lead in maintaining GMP & GDP standards across all site operations

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Participation in the internal audit schedule

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Audits of vendors, where required, and approving Technical Agreements with service providers.

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Hosting regulatory inspections and managing the audit report responses

• To perform the review and certification as suitable for release for sale batches of product processed at the site

Provide input (and participation) into the Management Review processEnsuring suitable arrangements are in place with suppliers for PI products e.g. WDAs

Ensuring validation and qualification requirements are met, where appropriate.

Advise Senior Management if there are any significant GMP compliance risks

Skills/ knowledge Essential

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Excellent written and communication skills, including experience of report writing and managing multiple client projects at any one time

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Good organisational and time management skills.

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Ability to work successfully as part of a team or using own initiative, sharing knowledge, collaborating with and supporting colleagues.

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Product release experience in a pharmaceutical background is ideal.

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Understanding of Regulatory Affairs and GMP compliance guidelines.

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Good problem management skills - focus on finding the right solutions and problem solving.Understanding of Regulatory guidelines, including EMA, BAEPD and EAEPC

Essential Experience:

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Proven pharmaceutical industry experience

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Experience working with all levels in an

organisation with the ability to influence

internal and external stakeholders

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Significant quality assurance QA and QC

leadership experience

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Experience in all dosage forms

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Hosting customer & Regulatory audits

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Supporting internal audits

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Risks associated with Falsified/Counterfeit Medicines
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