Quality Specialist

Quality Specialist

Saving lives starts with you. It starts with the chain of events you initiate when you work with McKesson Pharmaceutical - a chain that extends across the country and results in millions of people getting more from their healthcare.



As the leader in pharmaceutical distribution and supply chain management, McKesson Pharmaceutical delivers supply, technology and care management solutions to over 26,000 retail and 5,000 health system pharmacies nationwide. Our company includes three segments: Our domestic network of distribution centers ensures that our customers - and their patients - receive the right medicines and medical supplies at the right time. Our IT segment provides service and support for more than 2,400 systems in independent, chain, hospital, clinic and nursing-home pharmacies across the country. We work hard so that pharmacists can spend their time on patients - not paperwork. Our Center for Financial Services plays a critical role in ensuring that hospitals, pharmacies and retail chains receive pharmaceutical products quickly - usually within 24 hours. Our entire team works to ensure patients receive their medications efficiently and begin the process of healing.

Current Need
PURPOSE OF JOB

The post holder will be responsible for assisting the QualityManager in ensuring that licensed pharmaceutical products are manufactured, tested and released in compliance with cGMP, US FDA and other applicable regulations. The post holder will assist the auditing and associated activities in our contract manufacturer sites.



KEY RESPONSIBILITIES

- Participate in quality inspections of out sourced manufacturing facilities and supply chain including solid dose finished product manufacturing facilities, sterile finished product manufacturing facilities, to ensure compliance with cGMP and US FDA regulations.

- Track corrective actions and planned action agreements from inspections to closure.

- Participate in continuous evaluation and improvement of all quality aspects at manufacturing sites

- Remove and download data from temperature data loggers accompanying product receipts and organize return of data loggers to respective companies.

- Write summary reports of transport deviations and maintain files of temperature records for all shipments.

- Record, communicate and follow up on internal non market complaints e.g. product damaged in transit. Assist in investigations as appropriate

- Manage the receipt and dispatch of complaint samples from pharmacies.

- Track the receipt of complaints, ADE and queries received by NorthStar RXLLC ensure they are logged appropriately

- Obtain product samples from RDC and organise shipments as appropriate

- Photograph complaint samples and dispatch samples to customers

- Assist with queries from NorthStar with issues at RDC expiry, samples, receipt or regulatory authorities (DEA, Customs, DA and FDA)

- Record, communicate and follow up on internal non market complaints e.g. product damaged in transit. Assist in investigations as appropriate

- Participate in regular team and group meetings

- Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required.

Position Description
Responsible for developing, applying, revising, and maintaining quality standards for processing materials into partially finished or finished products. Designs and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and/or production equipment. Analyzes reports and returned products, and recommends corrective action. Prepares documentation for inspection/testing procedures.

Additional Knowledge & Skills
Education/Training:

Educated to degree level or higher, minimum B.Sc. (biological or chemical sciences)



Knowledge and Skills:

- Previous auditing experience (e.g. ISO9000) would be a distinct advantage

- Solid understanding and knowledge of cGMP, Quality Assurance and regulatory principles in a pharmaceutical manufacturing environment including ICH guidelines and 21 CFR part 210 regulations

- Excellent communication skills with ability to communicate at all levels within the organization.

- Demonstrate ability to lead customers to improve performance or effectiveness; including the ability to influence through effective communication and diplomacy.

- Ability to work independently and make decisions based on judgement and integrity.

- Proven analytical skills and ability to transfer findings into well written report formats.

- Experience / training in problem solving and process improvement methodologies.

- Ability to work effectively independently and with others to accomplish goals in a challenging environment.

- Excellent organisational and time management skills.

- Demonstrates and has an understanding of customs and beliefs of various groups or cultures. Understands how these differences affect performance and communication.

- Ability to travel up to 25%

Minimum Requirements
Experience:

3+ years experience in pharmaceutical manufacturing industry, in a similar type role within a progressive multinational organization. Substantial knowledge of one particular process or dosage form (e.g. sterile/injectables, Solid dosage forms, OTC or Medical devices) is a pre-requisite.

Education
4-year degree in related field or equivalent experience

Physical Requirements
General Office Demands

Agency Statement
No agencies please.

The material contained herein is provided for informational purpose only. All open jobs offered by McKesson Corp. on this recruitment system are subject to specific job skill requirements. The job skill requirements, qualifications, and preferred experience are determined by a subsidiary, office or department within the company which is offering the position, and all positions are subject to local prevailing employment laws and restrictions. This would include immigration laws pertaining to work authorization requirements and any other applicable government permissions or compliance.
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