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Job

Quality Operations Manager

  • Location

    Sittingbourne, UK

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    £80,000 - £90,000

  • Contact:

    James Brookes

  • Contact email:

    j.brookes@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    4 months ago

  • Expiry date:

    2019-07-07

  • Startdate:

    ASAP

We are currently partnered with a leading contract development and manufacturing organisation (CDMO) who are looking to hire a Quality Operations Manager to join their team. They are looking for an experienced Quality professional to join and lead a team within the Quality group in line with operational requirements, with an overall aim to ensure all products that are released are to the highest possible quality and in line with all standards necessary. This is a highly important position within the business as they continue to increase their market share and grow within the industry. 

Responsibilities include: 

  • Ensure release of products to market in line with expectations from consumers. 
  • Contributes, and where applicable facilitates the resolution of operational problems in Pharmaceutical Production whilst maintaining compliance to cGMP and license commitments.
  • Ensures in conjunction with Compliance Manager that all quality systems are managed appropriately, compliant to GMP and fit for purpose
  • Provides a consistent contact approach, aiming for consistency for any quality related issues
  • Manage the team to ensure appropriate investigation and timely closure of deviations, complaints and corrective and preventative actions
  • Manage the team to ensure that annual product review and periodic product reviews are carried out in a timely manner.
  • Assist the QC laboratories and Quality Compliance Group in ensuring site documentation is maintained to cGMP and agreed standards.
  • Development of Product Quality Attributes Records for all manufactured products at Queenborough.
  • Implements policies and procedures relating to Regulatory and cGMP.
  • Ensures the QP activity contributes to the performance measurement of the operational group at the Customer Service targets.
  • Ensures the department adheres to company safety standards and policies
  • Manages the batch audit, QA officer and Qualified Persons teams, which provides the expertise required to develop quality systems and enables product release and continuous improvement
  • Meets with Regulatory agencies during audits and develops close working relationships which aid the ‘agencies’ understanding of the companies direction and operations.

Qualifications needed:

  • Degree Qualified within a Scientific or related field and ideally 10 years of experience within the industry
  • Management experience is necessary
  • Indepth knowledge of Quality Regulations and standards for the EU and US. 
  • Strong Quality Assurance or Control background, ideally from a production environment. 

We are keen to speak and hear from experienced Quality professionals who might be interested to discuss this position in more details, so please apply now and one of the consultants will get in touch!