Responsible Person

Job description

·  Job facts

Reporting to the Head of Licence to Operate your key responsibilities will include (but not limited to):

·  Personal responsibility to ensure all responsibilities and duties as described in GDP Guideline 2013/C 343/01 are met, as follows:
·  Ensure a QMS is implemented and maintained.
·  Ensure that records are accurate and of a suitable quality.
·  Approve QMS procedures.
·  Ensure that initial and continuous training programmes are in place and maintained.
·  Coordinate any recall activities in a prompt manner.
·  Ensure customer complaints are dealt with effectively.
·  Ensure all suppliers and customers are approved.
·  Ensure that public service obligations are met.
·  Approval of subcontracted activities.
·  Ensure self-inspections are performed at appropriate regular intervals following a pre-arranged programme and necessary CAPAs are put in place.
·  Ensure appropriate records are kept of delegated duties.
·  Decide on the final disposition of returned, rejected, recalled or falsified product.
·  Approve returns to saleable stock, where applicable.
·  Ensure that any additional requirements imposed on certain products by law are adhered to.
·  Manage and support corporate and regulatory audits as required.
·  Manage artwork and transport verification checks prior to release of product to the local market(s).
·  Establish, maintain and encourage continual improvement to reduce complexity and improve efficiency.
·  Anticipate risks and changes in regulatory environment, to proactively mitigate them.
·  Ensure Quality critical activities are reflected in the local Business Continuity Plan.
·  Fulfill RP responsibilities personally and define delegated RP duties where required and ensure that the deputy (if applicable) has the appropriate experience, knowledge and training.
·  Maintain competence in GDP through regular training and be continuously contactable.
·  Mentor colleagues in the business to upskill in Quality and RP related skillsets.
·  Provide insight and guidance to the business in relation to GDP and quality matters.

Person/Skills Profile:

·  Qualification/Knowledge:
·  Thorough knowledge of applicable Irish statutory instruments and EU Directives, Regulations.
·  Responsible Person Training
·  Knowledge of Good Manufacturing Practices is desirable
·  Experience:
·  5-10 years experience in a quality role in the pharmaceutical industry
·  A minimum of 2 years experience as a Responsible Person (RP)
·  Relevant experience with Microsoft/Google applications e.g. Word/GoogleDoc, Excel/GoogleSheets, PowerPoint/GoogleSlides,

Skills:

·  Ability to achieve good working relationships and influence with persons in other skill centres, at all levels within the company including globally and in third parties.
·  Understanding and interpreting regulations, legislation and compliance terminology.
·  Very high level of communication skills (oral and written)
·  Assertiveness
·  Flexibility and open mindedness
·  Task Orientated
·  Attention to detail
·  Openness to giving and receiving constructive feedback
·  Ability to operate well under pressure
·  Planning and organisation skills
·  Professional ethics and integrity
·  Reliability
·  Logical thinking/problem solving/root cause analysis
·  Challenging Mindset
·  Calculated Risk Taking
·  Process Simplification
·  Fluency in English

·  Who we are

Roche Products (Ireland) Limited was established as a full affiliate of F. Hoffman-La Roche. The company is based in Citywest in Dublin 24, and deals with the commercial aspects of our Irish business, including sales and marketing, finance, regulatory and medical affairs for the Pharmaceutical Division.

Roche is an equal opportunity employer.