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Quality Manager - Batch Release (remote-based)

Employer
Hobson Prior
Location
Bedfordshire, Luton, England
Salary
GBP50000 - GBP60000 per annum
Start date
21 Jul 2021
Closing date
12 Aug 2021

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Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Hobson Prior are looking for a Quality Manager - Batch Release to be part of a brilliant pharmaceutical organisation who are focused on driving healthcare forwards, through the products they supply and the service they offer. This is a permanent position where you will be required to work remotely.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

  • Ensure all master BMR's and BPR's have been approved by organisation's QA.
  • Review the Batch BMR and BPR including API COA's, TSE/BSE Statements, Heavy Metal statements and Residual solvent statements.
  • Request and record any deviations/OOS noted on the batch records and ensure these have been approved.
  • Provide current methods and specifications to the QC Labs for quotation, review protocols and reports for AMT and Micro validation. - Review and approve deviations and OOS/OOT from the QC Labs and review the QC Certificates.
  • Raise change controls to note any major changes at the QC Labs and ensure all QC Labs are on the relevant MIA's and product licenses.
  • Review all transport temperature ensuring the data loggers have recorded the full duration of the transportation.
  • Record any temperature excursions or issues with data recording and notify the Manufacturers of these issues.
  • Review change controls from Manufacturers with changes to the methods and specifications and raise change control within the organisation's QMS.
  • Review change controls relating to launch of new products/new markets and ensure all actions are signed prior to launch.
  • Review the change control log to ensure all change controls with variations are closed prior to release of the product by the QP.
  • Any other assigned duties.

Key Skills:

  • Excellent communication skills.
  • Great attention to detail.
  • Good organisational and planning.
  • Strong computer skills including Microsoft Office and databases.

Requirements:

  • Minimum of 5 years relevant experience within a GMP/GDP Pharmaceutical industry.
  • Knowledge of GMP/GDP Quality processes and standards.
  • Experience in managing a small QA Compliance team.
  • Knowledge of current GMDP legislation.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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