Quality Specialist

Ortolan; Basildon; Hybrid; GBP 35,000 - 55,000; Full time

Job summary

Join a dynamic pharmaceutical company as a quality professional. In this role, you'll support the Quality System, perform audits, manage quality issues, and ensure compliance with Good Manufacturing and Distribution Practices. Ideal for graduates in Pharmaceutical Science with relevant experience in quality assurance.

Benefits

Health & wellbeing program

Employee recognition awards

Social events

Pension scheme

Qualifications

• Proven experience in manufacturing and quality assurance in pharmaceuticals.
• Familiarity with Quality Management Systems (QMS) and Pharmaceutical Quality Systems (PQS).
• Experience in GMP and GDP practices.

Responsibilities

• Perform GDP Audits and manage quality issues like CAPAs.
• Support quality system by reviewing batch files using SAP 4/HANA.
• Conduct internal and external quality audits.

Skills

Attention to detail

Interpersonal skills

Education

Graduate in Pharmaceutical Science or equivalent

Tools

SAP 4/HANA

Job description

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(3 days office based, 2 days work from home)

Salary: Competitive + Benefits + Bonus

If you are a pharmaceutical quality professional with experience gained in GDP Audits, then we'd love to hear from you. Join us to help improve peoples' lives and make healthcare better for everyone!

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Our core behaviours are:

• We keep our promises and do as we say.
• We value our heritage and foster an entrepreneurial spirit.
• We reinvest in our future - in our products, our brands, and our people.
• We give back to our communities.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, Spain, and South Korea.

We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

About the role:

In this role you will support the Quality System by reviewing batch files for timely release using SAP 4/HANA, supporting root cause analysis investigations, and managing quality issues such as CAPAs, GDP deviations, and change controls.

You will also participate in internal and external audits, ensuring all actions related to customer and internal audit findings are completed promptly.

Main responsibilities:

• Perform GDP Audits and progress QTAs with distributors.
• Provide Quality Operations support to approved vendors and customers and ensure that any risks are communicated effectively.
• Conduct checks for onboarding or requalification of customers and or GDP service providers.
• Performing SAP Quality Management activities such as approval of new materials, Master data related activities, new customers or vendors.
• Review pharmaceutical product batch files for timely release by Responsible Person (RP), Responsible Person for Importation (RPi), or certification by Qualified Person (QP), using SAP 4/HANA.
• Provide QA support to the business during root cause analysis investigation.
• Raise in a timely manner on request or using own initiative CAPA, GDP issues, Deviation and Change Control.
• Support activities required to effectively maintain the company Pharmaceutical Quality System.
• Monitor alerts for potential overdue for Complaints, CAPA, GDP issues, Deviation and Change Control.

About you:

• Graduate in Pharmaceutical Science or equivalent.
• Proven experience of manufacturing, API, solid dosage forms, liquids, creams and sterile products.
• Previous of facilitating OOS and Root Cause Analysis.
• Previous experience of working in a Quality Department of a pharmaceutical company.
• Experience in quality assurance or quality control within the pharmaceutical or biotechnology industry, in GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice).
• Familiarity with Quality Management Systems (QMS) and Pharmaceutical Quality Systems (PQS).
• Attention to detail, proactive and strong interpersonal skills to work collaboratively with other departments such as Supply Chain, Commercial, Projects and Regulatory.

What we offer:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.