Malta Medicines Authority

Post of Senior Quality Assessor

(Jobsplus Permit No: 800/2021)

1. The Malta Medicines Authority invites applications for post of Senior Quality Assessor 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 Quality Assessor 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 Quality Assessor from 2021 is that of €36,878 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 €1164.69 per annum for Continued Pharmacy Education, payable at the discretion of the Chief Executive Officer of the Malta Medicines Authority. Payments are subject to 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 Malta Medicines Authority’s mission is to protect and enhance public health through the regulation of medicinal products and pharmaceutical activities .

The Licensing Directorate within the Malta Medicines Authority (MMA) is responsible for assessing and approving applications for marketing authorisations. The division’s activities span National and European licensing, through mutual recognition, decentralised and centralised procedures, including post-authorisation activities.

Overall purpose

The Senior Quality Assessor will work as part of a multi-disciplinary team responsible for assessing and evaluating quality, safety and efficacy data.  The Senior Quality Assessor will assess the quality aspects of both initial and variation applications for marketing authorisations for chemical products and take decisions on their suitability for approval. The Senior Quality Assessor reports to the Licensing Director.

Functions

(a)   Assists line management in:

-Technical and scientific duties;

-Compilation of publications and reports; and

-Day to day management.

(b)   Evaluate:

-Technical assessment of quality data submitted in support of applications for marketing authorisation for human medicinal products, in accordance with established procedures;

-Quality data submitted in support of applications for variations of marketing authorisations, in accordance with established procedures;

-Technical assessment of quality data submitted in support of applications to conduct clinical trials in respect of human medicinal products (containing new chemical entities or established active ingredients); and

-Technical assessment of quality data submitted in support of scientific advice requests by pharmaceutical companies:

Any other quality data that needs technical assessment

(c)   Prepare

-Summaries and reports arising from evaluations;

-Assessment reports and authorisation documentation defining the rationale for their authorisation; and

-And formulate quality assessment policy and practice.

(d)   Ensure:

-Provision of technical advice;

-Representation at relevant European committees and working groups;

-Knowledge of state-of-the-art technologies through ongoing professional education and review of the published literature, including training;

-Communication with applicants, practitioners and any other relevant persons in relation to the above evaluations including liaison with fellow officers, medical, preclinical and pharmaceutical;

-Submission of reports as required and maintain appropriate records of meeting and activities;

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

-Facilitation of engagement and dialogue with Marketing Authorisation Holders, prospective companies and staff of the Authority in line with Top Management direction;

-Staff receives the necessary training to achieve their potential, by using delegation and empowerment to provide opportunities to develop staff and to plan for succession;

-Compliance with the set standards and the quality management system of the Authority; and

-Documentation and implementation of all policies.

(e)   Spearhead, coordinate and implement:

-Activities of the MMA;

-Assigned procedures;

-Ongoing and new projects within the Licensing Directorate; and

-Any other delegated projects and assignments.

(f)    Provide:

-Relevant and consistent information and advice to 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;

-Support to staff in order to maximise their potential, in turn delivering the work in an efficient and effective manner and in line with the policies and guidelines of the Authority;

-Advice to the Chairperson/ Directors as required, seeking to propose strategic solutions to the challenges in this area; and

-Technical assistance and scientific output/assessment.

(g)   Monitor and report performance against the key performance indicators for the area assigned.

(h)   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 MMA 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;

-Mentor/peer review of quality assessments carried by other Assessors.

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

(i)    Any other duties and responsibilities as assigned by the Chairperson/ CEO and Director/s.

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 Chemistry, plus minimum of three (3) years in regulatory science across the range of scientific activities in relation to the pharmaceutical development, manufacture, and quality control of human medicinal products of which at least one (1) year in the assessment of quality data for registration of medicinal products or equivalent experience in industry or academia related to the above areas.

Or

(b) A recognised Master qualification at MQF Level 7 in Chemistry, plus minimum of four (4) years in regulatory science across the range of scientific activities in relation to the pharmaceutical development, manufacture, and quality control of human medicinal products of which at least two (2) years in the assessment of quality data for registration of medicinal products or equivalent experience in industry or academia related to the above areas.

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.

Knowledge of pharmaceutical data for chemical entities will be considered an asset.

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 Agreement (Appendix 1), are to be submitted to hr.medicinesauthority@gov.mt by not later than 14 November 2021.