Quality Assurance ManagerCompany: Serana Europe GmbH
Job Description: Quality Assurance Manager
Reports to: Managing Director
Location: 17 Dorfstrasse, 14641 Pessin, Germany
Position Type: Senior Position – Part time
Primary ResponsibilityTo maintain and continuously improve the operation of the Integrated Management systems of the company to meet the requirements of ISO 9001, and other standards to ensure compliance with customer specifications and technical requirements of the business. Also responsible for the oversight of the production batch documentation program.
Duties & Responsibilities
- To develop, implement, maintain and continuously improve the integrated management system policies, procedures, instructions, specifications, standards and templates.
- Reviewing and assessing customer requirements and ensuring that these specific product requirements are met
- Developing and specifying technical / quality requirements for raw materials with key suppliers
- Identification, development and monitoring of objectives for quality, health and safety, and environment
- Working with operational personnel to develop and establish procedures, standards within the integrated management system
- Providing regular written management and technical reports on the performance of the management system.
- Preparation and release of process batch documentation to produce customer requirements
- Preparation of and communication of product batch release documentation to relevant personnel
- Maintaining and monitoring process outcomes for cleaning, environmental monitoring and validations
- Maintaining and monitoring the product stability database
- Reviewing, maintaining and monitoring all certificates of analysis / conformance from suppliers
- Preparation of and retaining all certificates of analysis for in-house production
- Scheduling and undertaking in house internal audits, supplier / vendor reviews and participate in external audits.
- Initiate and communicate audit findings to relevant personnel including action requests / change requests
- Initiate and follow through changes to the integrated management system
- Liaison with external consultants and management personnel as required
- Maintenance and retention of quality records for the integrated management system
- Identify training needs of the integrated management system for staff to meet specified requirements
- Communicating changes to the integrated management system to all relevant stakeholders
- Provision of Monthly performance and activity report to the Managing Director
- Other improvement projects as agreed by the Managing Director.
- At least 4 years’ experience in a biotech processing environment at a manager or leader role
- Knowledge of and mastery of ISO 9001 management system requirements
- Solid knowledge of batch production activities and GMP requirements / standards
- Good knowledge of European Pharmacopeia and/or Code of Federal Regulations (USFDA)
Key Skills and Competencies
- Ability to work semi-autonomously to achieve work requirement outcomes.
- Excellent numerical processing and statistical modelling skills for analytical requirements
- Fluent in technical German and English with strong oral/ written expression skills
- Proven problem / issue resolution skills
- Competent to perform internal audits and provide reports
- Ability to work closely in a team-based environment
- Ability to develop and implement projects / plans to achieve specified outcomes and objectives
- Ability to use computer software applications – MS applications, etc.
- Ability to deal with and cope with evolving circumstance and contingencies in the workplace
- Adaptability and flexible thinking to identify causal factors and develop plans to address such
- Attention to detail and ability to provide meticulous, and legible records
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