Senior Specialist, Quality Assurance

Job Description An amazing opportunity has arisen as a Senior QA Specialist, this senior role leads a team in the site Quality team

What skills you will need:

In order to excel in this role, you will more than likely have: The Senior Quality Specialist (POD Lead) is a self-directed, decision maker who is responsible for the management and oversight of the Quality Management Systems in the Drug Substance and Drug Product Intermediate facilities and for achieving the Quality deliverables in the Integrated Process Teams (IPTs) ensuring that the site meets all Manufacturer's Licence requirements for clinical and commercial production and is audit ready for both customers and agency inspections. Uses sound judgement to make good decisions based on information gathered and analysed. Responsible for providing leadership and guidance on site-wide quality assurance and regulatory compliance. Team Leadership: is accountable for the development and performance of the Quality Specialists in the IPT Quality POD team. The Quality Leader mentors the team, providing input and coaching on professional development, provides timely feedback and ensures that responsibilities are delivered in line with appropriate inclusion principles & behaviours. Teamwork skills: Interacts with people effectively. Able and willing to share and receive information. Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness. Excellent written and oral communication and interpersonal skills. Organizes and delivers information appropriately. Adapts to changing work environments, work priorities, organizational needs and diverse people. Motivation: Displays energy and enthusiasm. Maintains high level of productivity and self- direction.

What you will do:

• Lead the Quality Specialist team to ensure timely and effective completion of the Quality IPT core functions, including Application of Quality Risk Management to all process and systems.
• Production support and quality compliance guidance to ensure the facility meets and operates to all GMP requirements for development, clinical and commercial supply.
• Assist the IPT leadership team to deliver business results for the IPT in line with overall site goals.
• Documentation preparation, review & approval process required to support IPT operations.
• Prepare Annual Process and System Reviews.
• Raw material (API, SDI and excipient) and component release, targeting Batch review and release and deviation management process, Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
• Provide support to deviation investigations and process performance monitoring.
• Perform trending on deviations raised as required to identify improvement initiatives.
• Provide detailed knowledge of quality systems and ensure that root cause is identified and corrective actions as appropriate are completed.
• Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
• Deliver on System Improvements Ensure changes controls raised are documented, assessed, and completed.
• Participate in the generation and communication of quality metrics.
• Preparation, review & approval of site documentation including policies, procedures, associated reports and annual reviews, as required to support site quality systems.
• Participation in the internal audit program.
• Participate in the preparation for and hosting of regulatory and customer audits.
• Participate in Quality and site projects that may arise including New Product Introduction.
• Participate as a team member in the site new product introduction teams established to manage the transition of new products from Phase II2 through to PPQ and supply.
• Delegate for the Associate Quality Director as required.

Required Skills:

• Adaptability
• Adaptability
• cGMP Regulations
• Change Management
• Deviation Management
• Documentations
• GMP Compliance
• Good Automated Manufacturing Practice (GAMP)
• Manufacturing Quality Control
• Performance Monitoring
• Pharmaceutical Quality Assurance
• Product Disposition
• Production Support
• Professional Development
• Quality Assurance (QA)
• Quality Auditing
• Quality Management
• Quality Management Standards
• Quality Management System Auditing
• Quality Metrics
• Quality Standards
• Regulatory Compliance
• Risk Assessments
• Risk Control Assessment
• Risk Management
• + 2 more

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.