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Healthcare Operations Manager / Responsible Person - LHR

Location: Bedfont
Company: Expeditors
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"We're not in the shipping business; we're in the information business" -Peter Rose, Expeditors Founder
As a Fortune 500 company, Expeditors employs more than 15,000 trained professionals in a worldwide network of over 300 locations across six continents. Expeditors satisfies the increasingly sophisticated needs of international trade through customized solutions and seamless, integrated information systems. Our services include the consolidation and forwarding of air or ocean freight, customs brokerage, vendor consolidation, cargo insurance, time-definite transportation, order management, warehousing, distribution and customized logistics solutions. Expeditors is headquartered in Seattle, Washington.
To manage the healthcare operation across multi product and warehouse.
Activily work with sales and account managers to maintain and grow revenue
The Responsible Person is responsible for overall development, implementation, and upkeep of the Expeditors Quality Management System (QMS).
As the Responsible Person you will also be responsible for ensuring compliance with cGDP (current Good Distribution Practice).
· Guidelines on Good Distribution Practice of Medicinal Products for Human Use
(2013/C 343/01)
· Commission Delegated Regulation (EU) 2016/161
This role will comprise but not be limited to the below :-
- The RP should ensure that a QMS is implemented and maintained;
- He/she should focus on the management of authorized activities and the accuracy and quality of records;
- The RP should ensure that initial and continuous training programmes are implemented and maintained;
- He/she should be responsible for coordinating and promptly performing any recall operations for medicinal products;
- The RP should ensure that relevant customer complaints are dealt with effectively;
- The RP should ensure that suppliers and customers are approved;
- The RP should approve any subcontracted activities which may impact on GDP;
- The RP should ensure that self-inspections are performed at appropriate, regular intervals following a prearranged programme and necessary corrective measures are put in place;
- He/she should keep appropriate records of any delegated duties;
- The RP should follow customers instructions on the final disposition of returned, rejected, recalled or falsified products;
- He/she should follow customers instructions relating to the approval of any returns to stock;
- The RP should be contactable at all times.
The RP should ensure that any additional requirements imposed on certain products by national law are adhered to.
The holder of this post may delegate duties to appointed Deputy Responsible Persons, in line with agreed Group Procedures, but shall not delegate any of his/her responsibilities.
Knowledge
- Storage conditions/requirements for different types of pharmaceutical product;
- GDP legislation and relevant guidance;
- Requirements for storage facilities, temperature control and monitoring programmes, including mapping and qualification;
- Quality Management Systems and how to manage these effectively;
- Handling of returns/complaints/recalls;
- Bona Fide checks;
- Risks associated with Falsified Medicines;
- Expectations of a robust Technical (Quality) Agreement with any sub-contractors;
- Trained auditor
Experience
- Experience of picking /packing procedures and FEFO (First Expiry, First Out) principles;
- Handling complaints and customer queries;
- Active involvement in GDP regulatory inspections;
- Audited internally to monitor the Quality Management System (QMS) and preferably also external audits covering the various stages in the distribution process;
Service Provider approval process;
Expeditors offers excellent benefits:
- Paid Vacation, Holiday, Sick Time
- Health Plan: Medical, Prescription Drug, Dental and Vision
- Life and Long Term Disability Insurance
- 401(k) Retirement Savings Plan (US only)
- Employee Stock Purchase Plan
- Training and Personnel Development Program
All your information will be kept confidential according to EEO guidelines.
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