Job purpose and impact
The pharma & nutrition – manager, quality will perform product quality, safety risk management activities for products, external manufacturing facilities and other services relevant to the safe production of pharmaceutical and nutritional productsIn this role, you will collaborate with multifunctional teams to find and reduce quality risks and work with internal and external teams to address regulatory and customer requirements key accountabilities
Perform review of product manufacturing, testing records, certificate of analysis, label claim, etc., for release in sap
Performs ongoing relationship management activities such as establishing key performance indicators, building a supplier scorecard, trending of claims and complaints and maintenance of required documentation.
Perform risk assessment and implement risk mitigation plans
Participate in new product development, technology transfer assessment, label artwork reviews
Follow up on corrective actions to ensure that actions are taken in the appropriate time frame and key partners are informed.
Audit manufacturers to ensure that established quality standards are met.
Work closely with cross functional teams, including product design, product management and production to identify and mitigate quality risks.
Conduct root cause analysis for defects, nonconformities or other quality failures using fish-bone, why, how tools
Ensure regulatory compliance with formal external and internal quality standards.
Provide training, coaching and mentoring to internal, external members
Establish good storage, distribution of productsPerform mock recall.
Independently solve moderately complex issues with minimal supervision, while escalating more complex issues to appropriate staff.
Other duties as assigned qualifications
Minimum qualifications
Masters in pharmacy
Experience in product safety, quality, and data integrity (alcoa) auditing systems.
8 years in handling quality assurance of products produced by external manufacturers
Thorough knowledge of drugs and cosmetics act
Other minimum qualifications may apply preferred qualifications
Understanding of how to establish material risk and appropriate mitigation.
Good communication skills
Legal metrology requirements
Ability to objectively evaluate product safety systems and report findings in an organized manner.
Knowledge of licenses required to manufacture, store, sale of drugs.
Hiring insights
Job activity
Posted 30+ days ago
