Quality Assurance Office

Department: Quality Assurance

Reporting to: QA Manager/QP

Purpose

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.

• To ensure that processes and procedures are adhered to within the agreed timeframe where requested, or act as the SME (Subject Matter Expert) as appropriate.
• Act as the SME for key areas of the Quality Management System. To be determined based upon experience and skill set.
• Generate the QA department’s KPIs for which they are the named SME, to be presented in the monthly management meeting.
• Create and update procedures, policies and documentation as required to ensure consistent and safe pharmaceutical products as well as acting as an enabler to drive the Quality Management System forwards.
• Participate (as either lead or co-auditor) in self-inspections in accordance with the annual schedule.
• Identify potential quality issues and develop strategies to mitigate risks using appropriate risk management tools.
• Working with key internal and external stakeholders, analyse issues, identify root cause(s) and implement appropriate corrective and preventative actions in cases such as process deviations, complaints, non-conformances and out-of-specifications.
• Advise relevant departments on GMP matters and GMP compliance.
• To liaise with Contract Manufacturing Organisations (CMOs) as appropriate to compile Annual Product Quality Reviews (aPQRs) in line with annual schedule.
• To keep abreast of the regulations of the Medicines and Healthcare Regulatory Agency (MHRA) and additional European regulatory legislation and guidelines as appropriate.
• To keep up to date with the company’s current and future product range and offer GMP consultative support where required for New Product Introduction (NPI) and New Product Launch activities.
• To comply with the office policies and guidelines.
• To carry out any other responsibilities within the Quality department as requested by their Line Manger.

Key Measures / KPIs

• To meet QA monthly KPIs for activities for which they are the SME.
• Provision of timely responses to our customers and TPUK colleagues as a member of the QA Team.
• Liaise with CMOs and contract testing labs to ensure no delays in batch release QP and RPi releases.
• To be responsible and accountable for ensuring all internal activities related to batch release are completed to meet the company’s demands.

Personnel Specifications

Knowledge & Experience

• Strong knowledge of European GMP and GDP regulatory guidelines, regulations and procedures.
• Knowledge of European Market Authorisation bodies e.g. MHRA, EMEA.
• Good working knowledge of Microsoft applications e.g. Word, Excel.
• Exposure to working within a virtual organisation would be advantageous but not essential.
• Experience with relevant quality systems e.g. deviation management, change control and risk management etc.
• Understanding of New Product Introduction (NPI) activities would be advantageous.

Personal Skills

• Skilled at managing conflicting priorities
• Excellent communication
• Strong interpersonal abilities
• Accurate and methodical
• Detail-oriented
• Proactive problem-solver
• Team-focused and supportive

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

GDPR

How we use your data

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

Agency Notice

Please do not act on our behalf unless you have an agreement in place with TPUK.

We kindly request that recruitment agencies and third-party recruiters do not submit resumes or candidate profiles on behalf of any individual to our organisation unless there is a pre-existing agreement in place. Any unsolicited submissions will be considered property of Torrent Pharma UK Ltd, and we will not be obligated to pay any fees associated with such submissions. Thank you for your understanding.