Are you energized by a quality assurance role that allows you to enhance your systems and compliance expertise in a state of the art manufacturing environment? If so, this Quality Systems Specialist role could be an exciting opportunity to explore.
As a Quality Systems Specialist, you will be responsible for providing support to the site when implementing new products, review of records to ensure compliance with local and regulatory guidelines, and to execute Quality Systems actions.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Manage site’s Document Control System in compliance with all regulations (domestic and international), cGMP’s, cGLP’s, and corporate requirements
- Responsible for the management and approval flow of all site documents
- Oversee document life cycle management, including storage both on-site and off-site
- Author and review GMP documents such as SOPs and work instructions.
- Review documents as needed
- Manage site’s Stability Program in compliance with all regulations (domestic and international), cGMP’s, cGLP’s, and corporate requirements
- Design stability strategies with consideration to meet global market requirements and regulatory guidelines
- Create stability protocols for routine marketed products stability, Bulk Hold Studies, Thermostability Studies and Accelerated Stability as needed.
- Review of stability data to confirm expiry/shelf life, support commercial launch and project development team as appropriate
- Prepare documentation of trend analysis reports, and stability summary reports
- Investigate stability out of specification (OOS) results by applying root cause analysis and implementing effective CAPAs
- Serve as SME on project teams and provide guidance regarding stability regulations
- Ensure that stability aspects of new products and product optimizations are assessed, reviewed and maintained throughout all development phases
- Develop strong, collaborative relationships with outsourced partner to help facilitate completion of external Stability activities
- Maintain awareness of global regulations that impact stability
- Perform appropriate training related to subjects of expertise
- Generate business metrics to measure system performance
- Support and participate in the following team functions
- Regulatory audits, agency inspections and the site internal auditing program
- Support Supplier Management functions
- Periodic Product Review (PPR) program
- Change Management
- Raw material and product Specifications
- Product Testing Profiles
- Quality Risk Management
- Support the implementation and maintenance of effective Quality Systems to ensure that local operations are in full compliance with GSK standards and policies
Why You?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in Analytical Chemistry, Science, Engineering or similar
- 5 years in GMP environment, consumer health, pharmaceutical or similarly regulated industry OR Master’s Degree with 2 years of experience in consumer health, pharmaceutical or similarly regulated industry
- Experience working directly in stability program within the pharmaceutical or consumer health industry
- Proficient using Statistical software (i.e. Statistica/Minitab) and Microsoft PowerPoint, Excel and Word
- Ability to interpret data and results; identify trends through data review and analysis
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Master’s degree in Science, Engineering or similar
- 5 + years’ experience in stability science and analytical chemistry within the pharmaceutical or consumer health industry
- Significant knowledge and experience with stability guidelines and programming, document management, specifications, supplier management, change management and audits.
- Significant knowledge of dietary supplement requirements
- Product experience including dietary supplements and foods
- Knowledge of cGMP’s/FDA or other regulatory requirements
- Ability to multi-task and adapt to changing business requirements in a fast- paced environment
- Strategic planning and quick decision-making skills to meet timely organizational goals
- Leadership and organizational skills
- Good awareness of cGMP guidelines
- Excellent written and verbal communication skills, ability to work well with others
- Proven ability to successfully work with teams across time zones and cultures
- Able to interact effectively with the most senior levels of management both internally and externally
- Ability to plan and execute work independently with minimal supervision; communication capability should extend to all organizational levels
- Demonstrates initiative and ability to work across functions
- Proven ability to express problems / challenges and solutions in a clear and concise manner
- Flexible, adaptable and a strong team player and leader that fosters teamwork and promotes the GSK Values & Expectations
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
As a global healthcare company, we take on some of the world’s biggest healthcare challenges. By delivering a sustainable business, we provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
We are committed to widening access to our products, so more people can benefit, no matter where they live in the world or what they can afford to pay. Each of our three businesses benefits from GSK’s commercial infrastructure, integrated supply networks and significant global presence.
As a global company, our reward packages are designed to meet the needs of our geographically diverse workforce. They are benchmarked against industry standards and relevant to your job, no matter where you live.
Our reward package includes:
- A competitive base salary
- An annual bonus that rewards you for your individual contribution to our strategy, as well as business targets
- Benefit programs designed to support you and your family, including access to healthcare and well-being programs, pension plan membership, savings programs, time off and childcare support
- Employee recognition programs which reward exceptional achievements
- Share ownership schemes which link your reward to GSK’s longer term performance
- A performance and development program that helps you identify what you need to do, and the behaviors you need to demonstrate, to achieve success.
