QA Manager & Responsible Person
QA Manager & Responsible Person

QA Manager & Responsible Person

Full-Time 52000 - 78000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead quality assurance efforts and ensure compliance with industry standards.
  • Company: Join Polar Speed, a leader in temperature-sensitive pharmaceutical logistics.
  • Benefits: Enjoy 28-33 days holiday, private healthcare, and a 10% performance bonus.
  • Why this job: Be part of a dynamic team making a real impact in healthcare logistics.
  • Qualifications: Strong knowledge of GDP and ISO standards; management experience is a plus.
  • Other info: Flexible hours and travel opportunities across the UK.

The predicted salary is between 52000 - 78000 £ per year.

QUALITY ASSURANCE MANAGER & RESPONSIBLE PERSON

BASED: POLAR SPEED DISTRIBUTION LIMITED, SITE 2 Chartmoor Road, Leighton Buzzard, LU7 4WG

HOURS: 08:00 - 17:00 - MONDAY - FRIDAY - 40 HOURS PER WEEK

SALARY: £65,000.00 - £85,000.00 PER ANNUM - Dependant on experience

About Polar Speed:

Polar Speed has a reputation for quality, compliance, operational and customer-facing technology and monitoring solutions in the growing temperature-sensitive pharmaceutical logistics market in the UK. The company specializes in active temperature-controlled deliveries to hospitals, pharmacies, wholesalers, and medical care surgeries as well as to end patients which it serves through its homecare business. Its customers include some of the best-known pharmaceutical brands in the world.

Role Overview:

We are now looking for a QA Manager and Responsible Person to join our busy QA team at our Leighton Buzzard HUB or Birmingham HUB. You will be required to support the Head of QA, Responsible Person, and Responsible Person for Import, in the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and ISO 13485 standards, and in compliance with the EU GDP guidelines.

Key Responsibilities:

  • Supporting the Head of QA & RA, Responsible Persons, and Qualified Persons with the implementation and maintenance of the Quality Management system in accordance with the GMP and GDP guidelines, GPhC, ISO 9001, and ISO 13485 standards.
  • Ensuring ongoing compliance with relevant standards, legal requirements, regulations, and the PSDL documented policies and procedures.
  • Promoting a positive quality culture within the organization.
  • Participating in Quality System Management Reviews, including the preparation of meeting inputs, attendance and presentation at meetings, and the management of the meeting outputs.
  • Hosting and supporting in regulatory ISO and Client audits and conducting Supplier audits, internal audits, and self-inspections, including the preparation of CAPA plans.

Key Skills/Experience/Requirements:

  • Exceptional knowledge of GDP and the ISO 9001 standard; understanding of ISO 13485 would be an advantage.
  • Eligibility to become GDP Responsible Person and Responsible Person for Import.
  • Good communication skills to support internal and external customer queries both verbally and in writing.
  • Strong organizational and communication skills, with excellent attention to detail.
  • Excellent people management skills; previous line management experience would be an advantage.
  • Flexible in working hours, with the ability to travel within the UK on a monthly basis.
  • Good knowledge of Microsoft Office, Excel, PowerPoint, and Visio.

We offer a wide range of benefits including 28 days’ holiday (including bank holidays) building to 33 days (including bank holidays) in the sixth full holiday year (PRO RATA) and a company pension scheme, with 5% company contribution, private healthcare, UPS perks at Work scheme, and a 10% performance-related bonus incentive.

For successful applicants, Polar Speed will process basic disclosure criminal record checks.

QA Manager & Responsible Person employer: MISA Corporation

Polar Speed is an exceptional employer, offering a dynamic work environment in Leighton Buzzard where quality and compliance are at the forefront of our operations. With a strong commitment to employee growth, we provide extensive training opportunities and a supportive culture that values teamwork and innovation. Our competitive benefits package, including generous holiday allowances and a performance-related bonus, ensures that our employees feel valued and motivated in their roles.
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Contact Detail:

MISA Corporation Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land QA Manager & Responsible Person

✨Tip Number 1

Familiarise yourself with the ISO 9001 and ISO 13485 standards, as well as GDP guidelines. Understanding these frameworks will not only help you in interviews but also demonstrate your commitment to quality assurance.

✨Tip Number 2

Network with professionals in the pharmaceutical logistics sector. Attend industry events or join relevant online forums to connect with others who can provide insights or even refer you to opportunities at Polar Speed.

✨Tip Number 3

Prepare to discuss your experience with audits and compliance during the interview. Be ready to share specific examples of how you've successfully managed quality systems or resolved compliance issues in previous roles.

✨Tip Number 4

Showcase your people management skills by preparing examples of how you've led teams or improved team dynamics in past positions. This will highlight your ability to promote a positive quality culture within the organisation.

We think you need these skills to ace QA Manager & Responsible Person

Knowledge of GDP and ISO 9001 standards
Understanding of ISO 13485
Eligibility to become GDP Responsible Person
Excellent communication skills
Strong organisational skills
Attention to detail
People management skills
Experience in line management
Ability to conduct audits (Supplier, internal, self-inspections)
Preparation of CAPA plans
Proficiency in Microsoft Office Suite (Excel, PowerPoint, Visio)
Flexibility in working hours
Willingness to travel within the UK

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights your experience with quality management systems, particularly in relation to ISO 9001 and ISO 13485 standards. Include specific examples of your previous roles that demonstrate your knowledge of GDP compliance.

Craft a Strong Cover Letter: In your cover letter, express your enthusiasm for the QA Manager position at Polar Speed. Discuss how your skills align with their requirements, especially your ability to promote a positive quality culture and manage audits effectively.

Highlight Relevant Skills: Emphasise your communication and organisational skills in both your CV and cover letter. Mention any experience you have with internal and external audits, as well as your ability to prepare CAPA plans.

Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a QA Manager role.

How to prepare for a job interview at MISA Corporation

✨Know Your Standards

Familiarise yourself with ISO 9001 and ISO 13485 standards, as well as GDP guidelines. Be prepared to discuss how your experience aligns with these standards and how you can contribute to maintaining compliance.

✨Showcase Your Communication Skills

Since the role requires good communication skills, practice articulating your thoughts clearly. Prepare examples of how you've effectively communicated with both internal teams and external clients in previous roles.

✨Demonstrate Leadership Experience

Highlight any previous line management experience you have. Be ready to discuss how you've managed teams, promoted a positive quality culture, and handled challenges in a leadership capacity.

✨Prepare for Audits

Understand the audit process and be ready to discuss your experience with hosting and supporting regulatory audits. Think of specific examples where you contributed to successful audit outcomes or CAPA plans.

QA Manager & Responsible Person
MISA Corporation
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