Deputy Responsible Person

Kenny Whelan And Associates

Dublin North

Kenny-Whelan are recruiting a Deputy Responsible Person to be based on our Biopharma client’s site in Dublin North. This is a contract role and our client pays Competitive Daily rates. Contact Jenn Dinan on 021 4665408 and email your CV to jdinan@kenny-whelan.ie. QA Specialist Distribution - Deputy Responsible Person. Principal Responsibilities of Deputy RP is to support the RP with the following: Ensure the conditions of the Wholesale Dealer’s Licence are maintained. Ensure that the operations do not compromise the quality of medicines by ensuring that systems are in place to monitor storage of the product through the supply chain under the control of the company. Reviewing and advising upon the company’s standard operating procedures in relation to the operation of the licence. Ensure audit of the quality system is completed on a regular basis by periodic review of QMS and operational procedures for regulatory compliance through internal audit system. Ensure that adequate records are maintained in a secure manner. Participate in recall decision and support product recalls as required under the WDA. Ensure adequate supervision of any product recall system implemented. Support the preparation, implementation and on-going maintenance of the QMS systems and operational procedures, policies and other related documentation, in compliance with applicable legislation, regulations and regulatory guidance. Review and approve all standard operating procedures relating to GDP. Ensure the management of third parties (CMOs and affiliates) including regular review and auditing of their Quality Management Systems either by personnel or through the management of audits contracted to qualified third parties, to ensure compliance with applicable legislation and regulations. Ensure the review, and where appropriate, preparation and regular update of Quality Agreements and Service Agreements with licensees and 3rd party contractors. Attend Quality Management Review meetings and participation in the review of the APIT Quality and Regulatory Compliance Policy and Objectives for continuing suitability. Ensure that all records generated in relation to GDP are accurate and legible and maintained in a secure manner. Ensure that all personnel are trained, that continuous training programmes are maintained and that the implementation of the training programme is effective. Ensure any subcontracted activities which may impact on GDP are approved and that suppliers and customers are approved. Ensure that customer complaints are processed efficiently and effectively. Ensure the potential for drug shortage is escalated appropriately. Decide on the final disposition of returned, rejected, recalled or falsified products. Ensure returns to saleable stock are approved. Be contactable by the HPRA the Competent Authority at all times and provide the HPRA with the appropriate contact details. Have sufficient knowledge on the products APIT distributes and on the complexity of the operation. Keep themselves up to date with any changes in the legislation and with on-going training as identified. Ensure that any additional requirements imposed on certain products by national law are adhered to, as foreseen in Article 83 of Directive 2001/83/EC. Skills and Experience. Minimum 5 years of experience in Quality Assurance distribution and Good Distribution Practices. Previous experience in the capacity of a Responsible Person / Deputy Responsible Person. Minimum 2 years in international pharmaceutical and/or biotech industry with increased level of responsibility. Experience (international preferred) in working with a complex supply chain. Experience with engaging, influencing and supporting market affiliates. Previous experience in Shipping Validation an advantage. Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements. Demonstrated success records in auditing and improvement processes. Ability to operate efficiently in a complex matrix organization and international environment. Strong mature leadership and interpersonal influencing skills. Ability to represent the company and to negotiate at different levels contacts both internally and externally. Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels. Education. Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering. Responsible Person Certified. All applications will be treated with the strictest of confidence . Contact Jenn Dinan on 0214665408 and email CV's to jdinan@kenny-whelan.ie. This job originally appeared on RecruitIreland.com.

2406 days ago