Manager Quality Control (m/w) 100 %
Description du poste
Die Ophtapharm AG ist eine FDA/EU-GMP zertifizierte Produzentin im Pharmabereich (Ophthalmika). An unserem Produktionsstandort in Hettlingen bei Winterthur werden für internationale Märkte qualitativ hochstehende Produkte wie Augentropfen, -salben und -gele aseptisch produziert, abgefüllt und verpackt.
To strengthen our team in Hettlingen, we are looking for a
at the earliest possible date
Manager Quality Control (m/w) 100 %
Ihre Aufgaben
•
Lead and manage the QC department
, including Analytical Chemistry, and working closely with Microbiology and In-Process Control teams
•
Ensure that all analytical testing is in
compliance with cGMP, FDA regulations
(21 CFR parts 210/211), and relevant Swiss and EU regulations for sterile drug manufacturing
•
Oversee the
sampling, testing and release of raw materials, in-process samples, and finished sterile ophthalmic products
, ensuring timely and accurate results
•
Develop, implement, and maintain
robust analytical methods
and testing procedures
•
Drive
continuous improvement initiatives
within the QC laboratory to enhance efficiency, compliance, and data integrity
•
Initiating and
promoting automation and digitalization
of processes
•
Manage and mentor
QC team members; provide technical and regulatory guidance, training, and performance management
•
Represent
your area of responsibility during
Health Authority Inspections
(e.g., FDA, Swissmedic) and
Customer Audits
•
Collaborate cross-functionally
with Quality Assurance, Manufacturing, Regulatory Affairs, and R&D to support new product development and commercialization
•
Lead investigations, root cause analysis
, and
CAPA
for out-of-specification (OOX) results and other quality issues
•
Ensure
effective management
of laboratory equipment, qualification, calibration, and maintenance in accordance with cGMP
•
Maintain and ensure
adherence to a comprehensive stability program
for products marketed in the US
•
Oversee
preparation, review, and approval of QC-related SOPs, protocols, reports, and specifications
Ihr Profil
•
Advanced degree in Pharmacy, Chemistry, or related scientific field
•
Minimum 10 years
of experience in Quality Control, with at least 5 years in a leadership role within sterile pharmaceutical manufacturing
•
Strong knowledge of
FDA cGMP, USP, ICH guidelines, and EU GMP for sterile products
•
Experience working in or with facilities exporting to the
US pharmaceutical market
; prior involvement in successful FDA inspections is a must
•
Hands-on experience
with modern analytical instrumentation (e.g., HPLC, GC, UV-VIS, FTIR)
•
Demonstrated leadership
, decision-making, and project management skills
•
Curious and interested in
innovation and improvement
•
Excellent communication skills
as a point of contact across departments and functions
•
Fluent in German & English
Ihre Vorteile
•
Dynamic environment with development opportunities
•
Possibility of partially working remotely (20% max)
•
Free parking and public transport within walking distance
•
Above-average social benefits
Arbeitsort
Ophtapharm AG
Riethofstrasse 1
8442 Hettlingen CH
Haben Sie Fragen?
HR Hettlingen, Human Resources, beantwortet Ihnen diese gerne. Tel: +41 52 304 12 36.
Jetzt bewerben (https://apply.refline.ch/741965/0396/index.html?cid=5)
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