Royal DSM is a global science-based company active in health, nutrition and materials. DSM delivers innovative solutions that nourish, protect and improve performance. DSM's 25,000 employees deliver an annual net sale of about € 10 billion.
DSM Pentapharm is a science-driven Swiss company of more than 70 years; active in the fields of diagnostic reagents, kits and active pharmaceutical ingredients (APIs), with a focus on hemostasis and thrombosis.
Being a leader in the field of snake venom-derived APIs, DSM Pentapharm provides in-vitro diagnostic manufacturers and researchers a wide range of highly specific and sensitive substrates and reagent kits for clinical as well as research usage.
Operational Quality Assurance Manager 100% (f/m/d)
The Operational Quality Assurance Manager is responsible for supporting the Operational QA Team with assuring timely investigations/resolution of issues and implementation of corrective measures by using scientific principles, root cause analysis and compliance-minded actions related to manufacturing.
- Supports Quality Control with investigations regarding OOS results and deviations, as well as process improvement within the QC laboratory
- Assures that batch, product, process or other GMP related documentation such as deviations, OOS, CAPA, change notifications, production protocols, complaints and/or risk assessments is dealt with appropriately and correctly timed; Approves actions and close out of actions as applicable
- Conducts the final review and approval of batch documentation and releases batches
- Escalates failures to meet required quality standards (e.g. major and critical deviations or changes) to line management
- Actively involved in process improvement: Recommends changes in established processes to quality, Report and take any necessary action to prevent quality problems from occurring
- Designs and leads advanced training efforts for further shaping the GMP culture of the branch
- Represents the branch during customer audits and authority inspections
- Maintains awareness of current GMP and ISO-trends and manufacture processes and supports continuous improvement
- Assures products sold by the company comply with all relevant quality requirements and are safe for their intended use
- Provides support to QA department for special projects
Education and Experience:
- Minimum MSc in Biotechnology, Biology, Microbiology, Chemistry, Pharmacy or Food science related fields
- Minimum of 5+ years' experience with proven track record in a GMP/ISO production site
- Minimum of 5+ years' experience with batch record review and release activities
- Fluent in English & German
Knowledge, Skills and Abilities:
- Ability to multitask
- Self-driven, results oriented, able to work independently
- Excellent communication / presentation skills
- Excellent record keeping / documentation skills
- Excellent Organization skills
- Detail oriented
Do you have interest in this challenge? To apply for this vacancy, please apply on https://www.manpower.ch and complete application documents (cv, job references and proof of qualification) with your notice period and salary expectations. Please note that only online applications will be processed. Reference check procedures are part of the DSM Recruitment & Selection Process. You will be contacted when these references checks are required. Royal DSM is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as a qualified individual with a disability, or any other characteristic protected by law.