Opportunity Profile:
Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest – and highest quality – product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third-largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. We are currently seeking a Quality Analyst in our Global IT department. This role will operate out of our Canonsburg and Morgantown locations.
In this exciting role, the candidate will serve as coordinator to facilitate the change control process for application software changes. Coordination includes tracking the movement of software change requests from inception through release, communicating with internal IT professionals as well as external business personnel, administering the packaging of all associated release material and ensuring standard operating procedure is followed. This role will also facilitate the assignment, coordination and communication of software releases as well as coordinate change approvals liaising between approvers, reviewers, and initiators.
Additional responsibilities include:
1. Review and Approve test scripts and test runs to ensure compliance with internal procedures, policies, standards and FDA regulations.
2. As the configuration/release manager for SAP plans, organizes and tracks deliverables to adhere to team/release schedules.
3. Review SAP changes to ensure that compliance with FDA, SOX and SOPs have been satisfied.
4. Facilitates changes requested for release are available for migration in the SAP system and packaging of all changes for a release to our BASIS team.
5. Capable of performing effectively in a team, or alone and unsupervised.
6. Communicates effectively with team members and management from multiple business departments.
7. Prepare computer system validation documentation for enterprise applications, when applicable, in accordance with relevant regulatory protocols, such as 21CFR parts 11, 210, and 211, and GAMP.
8. Perform other duties as assigned.
Must possess skills/abilities in the following:
• Required in one or more Requirements and Testing Management systems such as HP Quality Center.
• SAP release management experience (preferred).
• SAP Solution Manager (CHARM) (a plus).
• BMC Remedy Change Management and Incident modules (preferred).
• One or more Version Management / Configuration Management systems such as PVCS, Unix CVS, Rational Clear Case, etc. (a plus)
• Required technical skills in Microsoft Office Suites.
• Required to have effective written and verbal communication skills.
• Validation Practices and Standards (such as GAMP) (a plus).
• Excellent communication, interpersonal and customer service skills are a must.
• A thorough understanding of SDLC and exposure to validation processes are also essential.
• Excellent collaboration skills promoting teamwork, innovative thinking, attention detail and quality.
• Ability to interact with all levels of the business.
• Strong work ethics and self motivated.
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