Regulatory Affairs / Quality Assurance Officer

Job Description
Pharma.MT Ltd in Malta is looking to recruit a Regulatory Affairs/Quality Assurance Officer to join their team on a full-time basis. The ideal candidate shall be responsible for activities regarding Pharmacovigilance and Safety product complaints, Regulatory Affairs, and Quality Assurance on a local level in the Territory.

The person shall also be responsible for:

• Collection, Documentation, and Handling of Safety/PV Reports including weekly reconciliation reports and periodic safety updates.
• Recalls, Deviations, and Change Controls related to Pharmacovigilance and upkeep of all records.
• Preparation, conduct, and monitor risk minimizations, audits, and inspections
• Ensuring all company products meet legislative requirements set by the Authorities and Suppliers.
• Keeping up to date with EU and national regulatory legislation and guidelines and communicating with regulatory authorities and suppliers
• Develop, maintain and improve the company quality system and ensure continued compliance with all GDP SOPs
• Provide expert advice and support to various departments on quality issues
• Responsible for Pharmacovigilance
• Preparation, Reviewing, and maintaining records of all technical documentation including technical contracts, certificates of analysis, and licenses.

The selected candidate shall have:

• Excellent knowledge of Microsoft office
• Meticulous record-keeping and highly organized
• Excellent analytical and problem-solving skills
• Excellent IT skills
• Flexibility in working hours
• Autonomy and highly responsible
• Ability to work to tight deadlines and under pressure
• Understanding of EU GDP regulations and activities
• Candidates having a science degree and experience a similar role will be given preference. 

Pharma.MT Ltd:
Pharma.MT is a young dynamic company yet we share many years of valuable experience. We are highly motivated and hard-working and as a result, have grown dramatically in the past few years and succeeded in securing various well known international brands. Our aim is to become the leading distributor for health care and allied products in Malta and Gozo. Pharma.MT Ltd has an excellent long-standing relationship with the medical community and a partnership approach with community pharmacies. We value our staff and invest heavily in employing and training the right people. Our team includes marketing and sales specialists, sales representatives, medical representatives, in-store promoters and merchandisers. Who are closely supported by graphic designers, regulatory affairs (qualified pharmacists including in house Qualified person and responsible persons), logistics and our finance and business development department.