What are the responsibilities and job description for the Senior QA Specialist (Pharmaceuticals) position at Harris Solutions?
We develop and produce active pharmaceutical ingredients, intermediates and complex dosage forms. Every day, around 2,300 committed employees in Switzerland, Germany, France, Malta, the USA and China work on innovative, integrated solutions for our clients.
Pennsville is our drug substance manufacturing site for the US market and provides spray drying operations globally.
At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make an attractive employer.
Your key tasks:
ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
- Reviews and approves executed production records, production investigations, Master Production Records, COAs and DMFs
- Reviews lab sample results and manufacturing records relative to qualification/validation activities.
- Conducts, writes, and reviews quality related investigations
- Responsible for cGMP compliance of assigned manufacturing operations / areas and conducts cGMP inspections
- Completes pre-campaign action items as assigned.
- Responsible for the conditional / final release of materials
- Reviews finished product labels.
- Prepares and reviews product trees
- Writes and reviews Product Validation / Qualification / Assessments documents, Equipment Qualifications / Assessments documents and
Computerized Systems Validations / Assessments documents
- Reviews, evaluate and approves minor equipment changes
- Conducts environmental monitoring
- Maintains QA databases for products / equipment
EDUCATION AND EXPERIENCE:
- BA/BS degree in microbiology (preferred), biology, chemistry, or engineering and 3-5 years of experience in auditing in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience.BA/BS degree in microbiology is preferred
- Thorough knowledge of cGMP is required
OTHER REQUIREMENTS:
- Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Siegfried Code of Conduct
- Adheres to all applicable SHE and CGMP regulations
- Must have excellent communication skills
- Must be conscientious and detail-oriented
- Must have excellent computer skills (MS Office, WinLIMS, SAP)
- Must be a team player
- Must be able to self-manage daily work and set priorities
- Must be able to manage projects and prioritize appropriately