QMCS Validations Specialist

ALK-Abello, Inc•Oklahoma City, OK

27d•Onsite

About The Position

ALK is a forward-thinking allergy company with a long tradition for allergy innovation. We are making a bold move into digital to transform the way consumers, patients, and healthcare professionals address allergies. ALK is devoted to improving quality of life for people with allergies by developing pharmaceutical products that target the actual cause of allergy. ALK is the world leader in allergy vaccination (immunotherapy) – a unique treatment that induces a protective immune response which reduces and potentially halts the allergic reaction. Since 1923, we have been working to improve the quality of life for allergy patients by developing products that target the cause of allergy. With over 2,200 employees and subsidiaries, production facilities and distributors worldwide we are in a unique position to further the advancement of allergy treatments. The company is publicly traded on NASDAQ OMX Copenhagen (OMX: ALKB) with global headquarters in Horsholm, Denmark and US Offices in Round Rock, TX, Bedminster, NJ, Port Washington, NY, Post Falls, Idaho, Luther, OK, Oklahoma City, OK and Mississauga, Canada. ALK has an opening for a full-time QMCS/Validations Specialist, located in our Oklahoma City, OK facility. This position will interface with levels of the organization on a daily basis observing the site’s compliance to current Good Manufacturing Practices (cGMPs). The successful candidate will manage the life cycle of computerized systems in manufacturing environmets. They will be capable of leading groups and independently working to establish quality management of computerized systems. The following is a list of specific duties, which are considered to be essential functions of this job. This list is not all-inclusive, and the employee who occupies this position is expected to assume any/all duties assigned by management, irrespective of whether such duties are specifically included in this list.

Requirements

Minimum required: Bachelor’s Degree in Engineering or Science and minimum 5 year relevant experience performing validations in pharmaceutical/ manufacturing environment
Prior experience with cGMP activity required
Experience with computerized system validations in a regulated environment
The ideal candidate must be willing to be held accountable and must work well with others in order to ensure that all objectives are met on a regular basis
Excellent written and verbal communication skills
Must be proficient in Microsoft Office applications, particularly Word and Excel
Excellent scheduling and time management skills with daily operations and special projects
Knowledge of cGMP, cGDP and cGLP
Knowledge of scientific writing and terminology
Continuous mental and/or visual attention to manufacturing functions
Must be able to handle multiple priorities at one time
Must be able to read, write and speak English
Effective judgment in a fast-paced, results-orientated environment

Responsibilities

Establish validation policies and procedures ensuring compliance with global regulations and corporate standards.
Management of computerized system validations, including system specifications, system architechure design, data integrity, user management, and risk analysis.
Work directly and indirectly with site management to schedule and execute validation activities to support the business plan.
Participate in Validation project teams.
Proactively identify and resolve validation issues
Author, execute and follow up closure documentation for Installation (IQ) Operational (OQ) and Performance (PQ) Qualifications.
Be knowledgeable performing review, authoring and revisions of Standard Operating Procedures and related manufacturing process documentation.
Perform duties related to the documentation and follow up to Corrective Preventative Action plans and Change Control.
Provide validation support for the introduction of new equipment or modification of equipment.
Preparation of summary reports, deficiency/discrepancy reports, gap analysis, risk analysis, failure mode & effect analysis, traceability matrices.
Knowledgeable in validation of pharmaceutical equipment including autoclaves, depyrogenation ovens, coolers, and other manufacturing equipment.
Assist with the development of such documents as: Validation Master Plans, Computerized System Validation, System Design Specifications, Users Requirements Specifications, Detailed Design Specifications.