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Senior Quality Assurance Engineer
2 months ago
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Environmental Conditions
Office
Job Overview
Company Overview
Thermo Fisher Scientific is a leading organization in the pharmaceutical development and manufacturing sector, specializing in sterile injectables and oral solid dosage forms.
Position Overview
The role entails providing essential quality assurance support, including compliance, regulatory assessment, and validation, to various business units and corporate management. This position involves supervising and guiding junior staff as necessary, ensuring quality functions are executed accurately and punctually, while facilitating effective communication and decision-making processes. Responsibilities include creating, reviewing, approving, tracking, and presenting documentation and procedures to ensure adherence to pharmaceutical regulations. The incumbent will identify non-compliance issues, evaluate recommendations, and implement corrective actions to enhance quality and productivity. Additionally, the role requires the establishment of systems to maintain compliance with evolving regulations and conducting quality systems training across the organization.
Key Responsibilities:
- Oversee, manage, and coordinate multiple complex projects across various departments to ensure timely delivery of outcomes.
- Act as the primary validation contact for negotiating agreements and resolving significant validation and regulatory challenges.
- Prepare, review, and authorize production, validation, and audit documentation, including master batch records and procedures.
- Analyze new and existing regulations, conducting gap analyses to identify deficiencies and implement necessary actions.
- Develop and implement strategies for process improvements and efficiencies to rectify system shortcomings.
- Lead and coordinate regulatory inspections conducted by agencies such as the FDA and MCA.
- Defend established policies and procedures during regulatory and client audits.
- Establish and oversee quality programs and plans, including validation and supplier certification initiatives.
- Minimum education required: Associate's degree.
- Bachelor's degree in Engineering or a related Biological Science field is preferred.
- A minimum of four (4) years of relevant experience in the pharmaceutical or regulated industry is required.
- At least two (2) years of validation experience is mandatory.
- Ability to thrive in a fast-paced environment, managing multiple tasks under pressure.
- Strong time management and prioritization capabilities.
- Exceptional interpersonal skills to foster effective working relationships, along with strong verbal and written communication abilities.
