Supply Chain Market Quality Operations Specialist 1 yr contract
Supply Chain & Market Quality Operations (SCMQO) Specialist (1-year contract)
The Supply Chain Quality Operations Specialist is responsible for assuring full compliance of company's products to company's quality standards and regulatory requirements. Responsible for the implementation, execution & monitoring of redressing activities. Provides quality oversight at contracted Logistic Service Providers providing secondary repackaging. Proactively partners with Affiliate Quality Operations, Regulatory, ALC Operations team and the LSP to ensure that all redressing/repackaging operations are in compliance with cGMP's, Regulatory standards and company's policies.
The Supply Chain Quality Operations Specialist will provide other quality support as may be required.
- Develop, review GMP/GDP related SOPs related to redressing and ALC operations.
- Prepares, reviews and maintain material and product specifications, redressing instructions and other GMP related documentation for redressed products.
- Performs batch releases for redressed products.
- Support and ensure compliance of the ALC Quality System.
- Coordinates GMP related activites with AQOs and regulatory team to ensure complaince to market requirements.
- Assures the investigations, corrective/preventative actions and commitments are in compliance with company's standards.
- Responsible for leading or assisting in root cause investigation in the event of a non-conformance.
- Present formal notifications of significant issues to senior management.
- Support conduct of third party due diligence and vendor assurance audits.
- Execute quality holds, product notifications and product recalls as directed.
- Manage quality processes for any product returns and material for destruction.
- Participate in internal and external audits.
- Resolve and conclude deviations and excursions within agreed leadtime.
- Ensures Logistics Services Providers SOPs are 'substantially equivalent' to the requirements within applicable policies.
- Assist GSCPM and QO colleagues in establishing processes that safeguard quality, compliance as well as continuity of supply.
- Facilitate quality culture by demonstrating compliance and initiating Zero Defects.
- Performs other jobs which may be assigned
- Bachelor's degree in Pharmacy, Chemistry, Biology, Microbiology, Biochemistry, Engineering or similar related disciplines.
- A minimum of 5 years' previous experience is required in positions of increasing responsibility within Quality Assurance or other relevant quality functions within the pharmaceutical industry.
- Experience in logistics & supply operation, is highly desirable.
- Strong communication and interpersonal skills to guide and lead cross-functional project groups.
- Adaptable to work priorities in response to complex and/or rapidly changing environments.
- Able to deliver results with limited resources.
- Ability to define, evaluate, recommend and implement continuous improvement opportunities in the regulatory compliance areas.
- SAP knowledge is preferable.
If you are interested in the role above, email your updated resume to email@example.com
We regret that only shortlisted candidates will be notified.
Licence Number: 10C5117 EA registration Number R1439496
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