CAREERS

Interested in joining our team, check out our job openings

We are a global player in the development, registration and distribution of generics, consumer health products and original drugs. We are continuously looking for new talent to join our team of passionate people committed to bringing innovation to public health. Make an impact!

Head of QA Operations (100%)

JOB POSITION

The Head of QA Operations is a key partner of the organisation and works in close collaboration with the corporate departments (e.g: QMS, Supply Chain, Development, Regulatory Affairs, Sales) as well as with external partners including Stragen’s affiliates , customers and the third parties contractors such as Contract manufacturers, API Suppliers, distribution centres and laboratories .
The Head of QA Operations manages, directs and support the activities of the Quality Assurance Operational staff to ensure compliance with all established systems and processes as per current regulations.
The Head of QA Operations monitors compliance and business needs with appropriate departments to ensure operational objectives are achieved.

RESPONSIBILITIES

The job position includes the following tasks and duties:
– Leads, manages, develops, trains and evaluates QA Operations personnel.
– Provides input to QA Operations personnel for the good performance of their responsibilities.
– Determines objectives, strategies, systems and procedures for the QA Operational staff.
– Interfaces and provides input to QMS for the establishment, maintenance and improvement of quality processes and procedures such as change controls, deviations, complaints, investigations, CAPA plan and risk quality management
– Ensure quality oversight of the day-to-day operations at suppliers and contract manufacturers as per corporate policies and applicable US and European regulations such as but not limited to Pharmaceutical, Food Supplements and Medical Devices requirements.
– Provides Quality Assurance related support to all departments.
– Interfaces with internal and external partners to ensure effective corrective and preventive actions are implemented for any recurring product/process discrepancies.
– Support alert and batch recall process.
– Maintains systems to track and trend key Quality Indicators and ensure KPIs are addressed and assures that any adverse trends or patterns are noted and are promptly addressed.
– Support quality agreement negotiation with relevant partners when required.
– Provide support to customers for QA operations topics

EDUCATION / WORK EXPERIENCE

– Pharmacist or equivalent degree in a Life Science, with at least ten (10) years of relevant experience
– Knowledge and understanding of regulations including but not limited to cGMP as defined by the US Food and Drug Administration and European Medicines Agency
– Working knowledge of current global initiatives including but not limited to Quality by Design, Process Validation and Data Integrity
– Experience with Contract Manufacturers Organization (CMO) and cross functional team
– Experience of successfully managing a team with leadership

QUALIFICATIONS

– Knowledge of applicable European and national regulations
– Strong Knowledge of GDP/GMP regulations
– Fluent in English, both written and spoken
– Strong team orientation including the ability to coach and mentor
– Strong written and verbal communication skills.
– Accountable for making independent decisions regarding daily QA Operations with minimal supervision
– Demonstrated interpersonal skills to work effectively with subordinates, peers, managers, cross-functional teams and subcontractors
– Strong analytical and problem solving skills
– Ability to set and manage priorities and schedule activities accordingly
– Accountable for making independent decisions regarding daily QA Operations with minimal supervision
– Excellent organizational skills with attention to detail and deadlines

Interested in a new challenge, please send your full application (cover letter, CV, work certificates) to rh@stragen.ch

SPONTANEOUS APPLICATION

You can directly send us a message.

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