Job Description
This job involves managing Quality Assurance activities in accordance with Good Manufacturing Practice (GMP) regulations. The role requires a strong understanding of GMP requirements and the ability to provide support and direction to all departments to ensure business, quality, and compliance goals are met.
This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities as required by Good Manufacturing Practice (GMP). These activities include:
- Incoming material release
- Batch release
- Change control
- Event management
- Supplier qualification
- Annual product review
- Validation compliance activities
The successful candidate will provide support and direction to all departments in respect of specific quality system elements to ensure business, quality, and compliance goals are met. They will also partner with other departments to ensure that compliance systems are implemented in an efficient manner.
The key responsibilities of this role include:
- Batch Record Review & material release to ensure compliance with GMP requirements
- Carrying out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints
- Carrying out tasks related to the management of batch records design and approval
- Carrying out administration of the SAP Quality Management Module
- Carrying out tasks relating to the management of site change control systems
- Compiling Annual Product Reviews
- Supporting all validation activities on site as described in the Site Validation Master Plan
- Approving and compiling where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.)
- Supporting system qualification and process validation activities
- Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
- Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site
- Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
- Perform GMP audits on-site and vendor facilities as required
- Performs on the floor walkdowns regularly to ensure process and facilities are maintained to GMP standards
- Carries out tasks related to the administration of site supplier approval process
The ideal candidate will have:
- Excellent interpersonal skills
- Ability to operate as part of a team is critical
- Customer focus
- Innovative
- Excellent communication skills both written and verbal
- Attention to detail
- Good problem solving skills
- Results and performance driven
- Adaptable and flexible
- Decision making
Qualifications and experience:
- Quality Assurance Specialist-QA Operations: Bachelors Degree in a scientific/technical discipline required
- A minimum of 3-5 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals
- Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position
- Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities