Quality Assurance Assistant

Purpose

General description of overall purpose of position.

To ensure the company operates within the guidelines of Good Manufacturing Practice (EU-GMP) and Good Distribution Practice (EU-GDP) and that products are manufactured, tested, released and distributed in accordance with the same guidelines.

Key Duties and Responsibilities

Please note, this list is not exhaustive, and responsibilities may include any other reasonable requests in line with your skill set.

1. To learn and gain a basic insight within the Quality department of Torrent Pharma UK Ltd on how the quality system is utilised to manage the business requirement.

2. To provide support for the Quality Assurance department to ensure that processes and procedures are adhered to within the agreed time.

3. To issue all SOP’s on time and ensure all training is completed before the SOP is made effective.

4. To assist other members of the QA Team with administrative and research duties associated with their responsibilities.

5. To act as Subject Matter Expert (SME) for administrative Subject Matters; to be determined based upon experience and skill set.

6. To generate specific batch release checklists and complete variable data prior to QP and RPi review.

7. To review temperature data for all batches during transit to ensure that the product was transported according to the registered storage conditions.

8. To log all change controls and provide change control reference numbers to initiators.

9. To approve and close all change controls relating to artwork where required.

10. To complete customer verification checks on a monthly & quarterly basis and report any terminated/revoked/suspended customers to the relevant departments.

11. To generate the QA departments KPI’s for which they are the SME, to be presented in the monthly management meeting.

12. To carry out any other responsibilities within the Quality department if requested by their Line Manager.

Key Measures/ KPIs

1. To meet QA monthly KPIs for activities for which they are the SME.

2. Timely assistance to members of the QA Team and our customers.

3. To fully manage all artwork change controls they are accountable for and ensure all are completed within the set deadlines.

4. To prepare all documentation and communication regarding their SME responsibilities against KPI’s and circulate to TPUK management within the set monthly deadlines.

Personnel Specifications

Knowledge & Experience

· Understanding of European GMP regulatory guidelines, regulations and procedures

· Knowledge of batch release processes

· Knowledge of GMP and GDP

· Knowledge of European Market Authorisation bodies, eg. MHRA, EMEA

· Knowledge of existing company product range and pipeline

· ​ Good working knowledge of Microsoft Word

· ​ Good working knowledge of Microsoft excel

· Supportive of team environment

Personal Skills

· Ability to manage conflicting priorities

· Excellent communication skills

· Strong interpersonal skills

· Accurate

· Methodical

· Attention to detail

· Proactive

Torrent Pharma Values and Behaviours

All employees at Torrent Pharma are expected to demonstrate and embrace our Values, Behaviours and Ways of Working.

Our Values:

· Integrity

· Passion for Excellence

· Participative Decision Making

· Concern for Society & Environment

· Fairness for Care

· Transparency

Torrent Pharma Company Benefits

We are very proud to offer the following in your employment contract package;

· 25 days annual leave (in addition to public bank holidays), plus Length of Service Awards

· Private Medical Insurance – Vitality Healthcare

· Group Life Assurance

· Enhanced Employer Pension contribution of 5%

· Hybrid working

· Onsite parking

How we use your data

Please refer to our privacy notice on our website www.torrentpharma.co.uk for more information.