Quality Assurance Specialist

6 months ago

Chester, United Kingdom Sinclair Pharma Full time

Sinclair are currently recruiting for a QA Specialist at their Chester office for a 12 month fixed term contract. The QA Specialist will support the Quality Team in creating and maintaining a Quality Management System capable of satisfying the company’s needs. Ensuring ongoing compliance with ISO 13485 requirements in the UK and supporting the wider organisation with the Corporate QMS. The QA Specialist will be managing the day-to-day QMS functions including audits, change management and deviation management.

**Location: Hybrid working, 3 days a week. Eden House, Lakeside, Chester Business Park, Cheshire, CH4 9QT**

**About Sinclair**

Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.

This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.

**Our Vision**

Providing aesthetic excellence globally.

**Our Mission**

Driving the advancement of product quality and customer satisfaction, investing in innovation and people.

**Our Values**
- Act with Integrity
- Be results driven
- Embrace your winning spirit
- Stay ahead of the game
- One team, one goal

**Key responsibilities**
- Assist in establishing and maintaining a Quality Management System, capable of meeting applicable regulatory and company requirements including ISO 13485.
- Creation and update of standard operating procedures and controlled documents.
- Ensure training is conducted in accordance with agreed timelines and to maintain up-to-date personnel training records.
- Manage the progress of CAPAs and Change Controls ensuring Quality-related aspects are completed in accordance with agreed targets.
- Processing of non-conformances and complaints, identifying root cause and implementing appropriate corrective and preventive actions (CAPA).
- Assist in the preparation of input slides for Management Review Meetings.
- Conduct internal audits and provide support in external audits.
- Maintenance of the eQMS for document management and training
- Maintenance of the Computer System Validation records and ongoing tracking of periodic requirements
- Assist in the approval process for Distribution Partners for international sales

**Your Skills & Experience - Do You Have What it Takes?**

Essential:

- Life Sciences degree or equivalent experience
- Experience of Quality Management System operation and maintenance
- Knowledge of ISO regulations

Desirable:

- Knowledge of ISO 13485
- Knowledge of Medical Device Regulation

**A bit about you - do you fit this description?**
- IT literate - to manage/administrate the eQMS and other systems relied upon by the business including Excel and Sharepoint
- Analytical - able to conduct investigations and decide on appropriate corrective actions to remedy issues.
- Methodical - able to créate and follow procedures to ensure consistency and compliance
- Excellent communication and organisational skills
- Highly customer focused
- Hands-on approach, with a “can do” attitude
- Ability to prioritise, demonstrating good time management skills

**What We Offer**

We offer:

- 25 days annual leave (plus bank holidays)
- Bonus based on performance
- Opportunities for development and progression
- Company pension scheme
- Private medical insurance
- Healthcare Cash plan
- Health Screening
- Employee Assistance Programme
- Store discounts
- Tech and Cycle Scheme
- Discounted dining card
- Cycle to work scheme
- Green car scheme
- Holiday buy and sell
- Life Assurance scheme

We have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability and autonomy. The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development and a varied workload. You will often be included in projects that require you to collaborate cross-functionally.

This is an exciting opportunity to join a successful company, with big ambitions for the future.

If this sounds like you and you meet the requirements, please apply, we would love to hear from you.

**Sinclair does not accept speculative or unsolicited CVs from Recruitment Agencies. Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void.**

**Job Types**: Full-time, Fixed term contract

**Benefits**:

- Company pension
- Free parking
- Health & wellbeing programme
- Private medical insurance
- Referral programme
- Store discount

Schedule:

- Monday to Friday

Supplemental pay types:

- Bonus scheme

**Experience**:

- Quality assurance: 2 years (required)

Work Location: Hybrid remote in ch4 9qt

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