Manager Quality Assurance Bucharest

Manager Quality Assurance
Bucureşti
Bucharest, Bucharest, Romania

The opportunity

Position responsibilities include Quality oversight for Manufacturing, Packaging and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products.

This oversight includes but is not limited to: the establishment and execution of procedure; Establishment Licensing, Quality on the Floor activities including audit and release; handling of laboratory, deviation and complaint investigations; CAPA creation and implementation; trending and metrics, compliance with regulatory requirements; verification that equipment, facility and utility systems are maintained, calibrated and qualified in accordance with established requirements.

Lead the development, standardization, implementation, monitor effectiveness and continuous improvement of the Quality Systems, global and local compliance. Influence quality and compliance initiatives to implement robust and proactive process improvement programs within a strong quality culture to align and demonstrate compliance to Good Manufacturing Practices.

Key Responsibilities

• Leads the QA organization on site - Quality Compliance, Quality Systems, QP and Quality Assurance.

• Ensure a current Quality Management System is in place and continuously improved

• Ensure products are manufactured, released and distributed in accordance with c
GMP requirements and registered specifications.

• Assess and Mitigate Risks-- Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market. Work with the business to assure compliant and reliable supply

• Promote a Sustainable Culture of Quality---Create, develop and maintain a culture of enhancing quality throughout the entire site operation. Create a space where people can speak openly and are encouraged to present new ideas to improve quality

• Maintain strong partnership with Operation, Supply Chain, Engineering, MS&T

• Provide effective Quality leadership during internal, customer and Health Authority inspections

• Ensure that Quality KPIs are meeting
- defined targets, ensures CAPA commitments are implemented in a timely manner and its effectiveness is monitored periodically

Education

• Required – Chemistry, Biology, Pharmacy. QP certification is required

• Preferred - Master or equivalent degree in Chemistry, Biology or Pharmacy

Key Requirements

• Minimum of 5 years pharmaceutical manufacturing site quality operations and leadership experience, including:

o Deep knowledge of c
GMP requirements of local and major international authorities like EMA and US FDA for products and process,

o Deep knowledge on sterile dosage forms manufacturing and sterility assurance

o High level of understanding of manufacturing, packaging, ICH guidelines as well as CMC content of regulatory submissions,

o Knowledge of chemical/pharmaceutical production operations/ lifecycle, production equipment/ validation and relevant technologies and product types,  

o Deep knowledge of Quality Systems

• Experience leading, inspiring and coaching teams

• Experience developing and implementing and continuously improve existing and new, efficient, and effective business processes

• Must have adequate practical knowledge of pharmaceuticals manufacturing and/ or control

• Must have practical knowledge of pharmaceutical cross functional operations (e. g. , Supply Chain, Engineering, Production)

The candidate should be able to delegate, well organized, should be able to adapt and lead change.