Malta Medicines Authority

Post of Senior Medicines Inspector

(Jobsplus Permit No: 216/2024)

1. The Malta Medicines Authority welcomes applications for the post of Senior Medicines Inspector  within the Authority.

2. Terms and Conditions

2.1. The selected candidate will be employed as a Professional Officer in Scale 4, according to its Collective Agreement.

2.2. The post of Senior Medicines Inspector is subject to a probationary period of twelve (12) months.

3. Salary pegged to the post

3.1 The salary attached to the post of Senior Medicines Inspector is that of €39,646.12 per annum.

3.2 Other benefits include:

-A non-pensionable Pharmacist Class Allowance of €8500 for candidates who are registered pharmacists, while for non-registered pharmacists the non-pensionable market corrector allowance is of €3800 per annum,

-A Cash Allowance of €1466 per annum,

-A reimbursement of a maximum of €1164.68 per annum for Continued Pharmacy Education, payable at the discretion of the Chief Executive Officer of the Malta Medicines Authority. Payments are subject to eligibility, submission of receipts, etc. as applicable, and

-A Qualification Allowance (if applicable) as established by the Central Administration in line with the Medicines Authority Collective Agreement.  

4. Duties

The Mission of the Malta Medicines Authority is to safeguard public health through the regulation of medical products and pharmaceutical activities for human use.

Overall purpose

The Senior Medicines Inspector is responsible for the evaluation of manufacturing processes and the enforcement of generic good practice (GxP) standards of medicinal products, as part of a multi-disciplinary team.

Functions

(a) Assist Line Management in:

-  Pharmaceutical, technical and scientific duties;

-  Compilation of publications and reports; and

- Coordination of GxP procedures - GxP includes Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP).

(a) Evaluate:

- Quality technical data submitted in support of applications for GxP requirements/licences/certifications/registrations, in accordance with established procedures, current legislation and standards;

- Administrative and quality/technical data submitted in support of applications for variations and renewals of GxP authorisations, in accordance with established procedures, current legislation and standards;

- Systems related to the determination of relative GxP status including inspections of manufacturing facilities;

- Corrective and Preventive Actions (CAPAs) following GxP inspections;

- Batch recall incidents and quality defect monitoring;

- Any other data related to GxP standards.

(b) Prepare:

- For and execute GxP inspections as assigned and as required both domestically and abroad, including third countries;

- Inspection reports and pre-and post-inspection letters;

- Reports on batch recall incidents and quality defect monitoring; and

- Internal documents such as Standard Operating Procedures, Policies and guidelines, as required.

(c) Ensure:

- Provision of technical advice;

- Continuous engagement in updating and ensuring knowledge of state-of-the-art technologies and updated standards and guidelines through ongoing professional education and review of published literature, including training requirements and training sources;

- Communication with applicants and other relevant persons in relation to the manufacturing processes and the enforcement of GxP standards of medicinal products including liaison with fellow officers and pharmaceutical professionals;

- Activities related to the manufacturing processes and the enforcement of GxP standards of medicinal products meet requirements in terms of accuracy, completeness and timeliness;

- Submission of reports as required and maintain appropriate up-to-date records of meetings and activities;

- Timely planning, delivery and oversight of the procedures in line with the strategy of the Malta Medicines Authority and the resources available;

- Facilitation of engagement and dialogue with applicants, pharmaceutical stakeholders and staff of the Authority in line with Top Management direction;

- Compliance with the quality management system of the Malta Medicines Authority and regulatory requirements, including development and update of quality documents and standards; and

- Documentation and implementation of all policies and Standard Operating Procedures.

(d) Spearhead, coordinate and implement:

-       Managing systems that ensure effective and efficient batch recall procedures and quality defects procedures;

- Monitoring of the quality and safety of authorised medicinal products through a sampling and quality defect post-marketing surveillance programme;

- Investigations of alleged breaches of the Medicines Act (Chapter 458 of the Laws of Malta) and its subsidiary legislation, enforcement of regulations governing medicinal products and their follow up in line with policies and procedures of the Malta Medicines Authority, including attending and witnessing in judicial proceedings;

- Activities of the Malta Medicines Authority;

- Assigned procedures;

- Ongoing and new projects within the Malta Medicines Authority; and

- Any other delegated projects and assignments to continuously improve processes, tools and systems for the benefit of the Malta Medicines Authority.

(e) Provide:

- Relevant and consistent information and advice to the Chief Executive Officer/Director/s and staff under the direction of the assigned Director, committees, government department, professional bodies and other bodies, as appropriate;

- Advice to committees established to provide guidance or overview the assessment process or any other procedure of the Authority. These include the Medicines Advisory Committee, the Borderline Committee, the Enforcement Committee, the Inspectors’ Review Group and the Medicines Review Board; and

- Technical assistance and scientific output/assessment.

(f) Continuously improve the performance of the organisation by:

- Promoting and maintaining good professional and ethical working relationship with colleagues and stakeholders;

- Promoting communication and liaison between different sections of the organisation;

- Representing the Authority at meetings, including meetings of the Committees/ Working Groups, seminars, conferences and other fora, both locally as well as abroad;

- Encouraging and ensuring the effectiveness and efficiency of the quality of service; and

- Promoting the vision, mission, values, strategy and objectives of the Authority.

(g) Any other pharmaceutical duties and responsibilities as assigned by the Chief Executive Officer/Director/s and/or appointed substitute.

5. Eligibility requirements

5.1 By the closing time and date of this call for applications, applicants must be:

(i) (a) citizens of Malta; or

(b) citizens of other Member States of the European Union who are entitled to equal treatment to Maltese citizens in matters of employment by virtue of EU legislation and treaty provisions dealing with the free movement of workers; or

(c) citizens of any other country who are entitled to equal treatment to Maltese citizens in matters related to employment by virtue of the application to that country of EU legislation and treaty provisions dealing with the free movement of workers; or

(d) any other persons who are entitled to equal treatment to Maltese citizens in matters related to employment in terms of the law or the above-mentioned EU legislation and treaty provisions, on account of their family relationship with persons mentioned in paragraph (a), (b) or (c); or

(e) third country nationals who have been granted long-term resident status in Malta under regulation 4 of the “Status of Long-Term Residents (Third Country Nationals) Regulations, 2006” or who have been granted a residence permit under regulation 18(3) thereof, together with family members of such third country nationals who have been granted a residence permit under the “Family Reunification Regulations, 2007”.

The advice of the Citizenship and Expatriates Department should be sought as necessary in the interpretation of the above provisions.

The appointment of candidates referred to at (b), (c), (d) and (e) above would necessitate the issue of an employment licence in so far as this is required by the Immigration Act and subsidiary legislation. The Jobsplus should be consulted as necessary on this issue.

Qualifications and Experience

(ii) Proficiency in the English Language;

(iii) Be in possession of:

(a) A recognised Doctorate qualification at MQF Level 8 in  Pharmacy or Chemistry or Biology or Medicine or Pharmaceutical Technology, or a comparable professional science qualification, plus a minimum of three (3) years relevant work experience out of which at least one (1) year must be in Good Manufacturing Practice (GMP) - of the European Union or of the Pharmaceutical Inspection Co-operation Scheme (PICS) - for full manufacture of sterile finished dosage forms, in the production and/or quality or quality related departments. Candidates with the above qualification having from the minimum three (3) years relevant work experience at least one (1) year experience working as a GMP (EU/PICS) inspector executing inspections for sterile manufacturing facilities shall also qualify as being eligible.

Or

(b) A recognised Master qualification at MQF Level 7 in Pharmacy or Chemistry or Biology or Medicine or Pharmaceutical Technology or a comparable professional science qualification, plus a minimum of four (4) years relevant work experience out of which at least two (2) years must be in a manufacturing facility with Good Manufacturing Practice (GMP) - of the European Union or of the Pharmaceutical Inspection Co-operation Scheme (PICS) - for full manufacture of sterile finished dosage forms, in the production and/or quality or quality related departments. Candidates with the above qualification having from the minimum four (4) years relevant work experience at least two (2) years’ experience working as a GMP (EU/PICS) inspector executing inspections for sterile manufacturing facilities shall also qualify as being eligible.

Applicants with a recognised qualification in Pharmacy should preferably be registered with the Malta Pharmacy Council as Pharmacist.

Applicants with previous experience in manufacturing of biological medicinal products for human use and/or having Qualified Person eligibility status, as per article 48 of Directive 2001/83/EC, for sterile finished dosage forms, can be given preference.

Commitment

Only applicants who are ready to accept to carry out GxP inspections, particularly GMP inspections, in third countries (anywhere in the world outside of the EU) will be accepted for this post. Successful applicants must be available at all times and be ready to perform up to ten (10) GMP inspections per annum, if need be, in any third country for which there is no advice by the Malta Ministry of Foreign Affairs not to travel. Successful applicants upon notice of intent for engagement after publication of the selection results are expected to sign an agreement before commencement of the employment contract. 

6. Submission of supporting documentation

6.1 Qualifications and experience claimed must be supported by certificates and/or testimonials, copies of which should be attached to the application. Scanned copies sent electronically are acceptable.

6.2 Original certificates and/or testimonials are to be invariably produced for verification at the interview.

7. Selection procedure

Eligible applicants will be assessed by a Selection Board to determine their suitability for the post.

Eligible applicants who have commitment to learning and development will be preferred.

8. Submission of applications

Applications, together with a curriculum vitae showing qualifications and experience and a signed Data Protection Consent Statement (Appendix 1), are to be submitted to hr.medicinesauthority@gov.mt by not later than noon until 23rd March 2024.