Job Description Summary
Manage projects and / or processes and allocated resources to support departmental projects and objectives according to agreed timelines and standards and assure compliance with GMP. The projects run generally across the departments where the Manager QA often leads the project team.
Quality Compliance on shopfloor and especially in area of environmental monitoring and pest control.
Supports QP in timely release of GMP relevant documents by an appropriate review and addressing of gaps and questions.
Responsible for Complaint handling ensuring compliance to internal and external regulations.
Job Description
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Manage portfolio of projects, support a discipline and / or provide a service. If applicable, may provide functional expertise in area of responsibility.
Create and review GMP relevant documents in own area of responsibility (e.g. batch records for material manufactured and packaged internally, SOPs, procedures, records, third party work)
Negotiate and clarify deficiencies in GMP documents in area of own responsibility with the
line unit.
Provide support to internal policies (GOPs, Manual), and global compliance initiatives.
Develop and improve GMP processes to meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidances, SOPs, HSE etc.).
Organize, coordinate Pest Control program tasks. Supervise external partners for pest control.
Prepare reports and risk assessments in area of responsibility.
Promote and enforce compliance to guidelines.
Support inspections and audits and perform self-inspections and audits if applicable.
Responsible for BRR and coordination of batch release.
Support artwork changes as respective quality role.
Responsible for Deviations and Complaints as QA representative.
Management of quality data in SAP
What you’ll bring to the role:
Essential Requirements:
Basic degree in scientific, technical or relevant discipline
(BS or equivalent) or comparable education / experience
Basic scientific, technical and regulatory knowledge in a
specific area
Good knowledge of cGMPs and working knowledge
Basic organization skills
Good knowledge in German and English
As part of your application, please submit your current CV as well as proof of your highest educational qualification (e.g., diploma, master’s degree, doctorate). Additional documents such as employment references may be uploaded optionally but are not mandatory.
Compensation Structure & Criteria:
Sandoz compensation is determined by job level, qualifications, niche skills, experience, and location within company salary ranges. Fully proficient and highly effective employees can expect a starting salary around market median, with those new to the level or with less functional depth at the lower end of the range and those with sustained superior or niche skills towards the higher end of the range. Internal equity and external market data inform our range placement. Annual salary reviews consider performance outcomes, market alignment, and business needs.
Job location: Holzkirchen, Germany
Starting pay range: EUR 54,100 - 100,500
Variable compensation: 5% performance-based bonus
Additional benefits include: 30 vacation days per year (in full time), 1.200€ vacation payment (in full time), €40/month in capital-forming benefits (in full time), company pension, flex-hybrid working 50% per week in the office, access to our learning & development platforms Skillsoft & Learnlight, Access to our employee share program “OurShare”
Pay frequency: Monthly
Expected…