Major accountabilities:

• Always ensure, and as a priority, compliance with the concepts of data integrity in Quality operations.
• Establishes and fosters an environment of continuous improvement by proactively challenging practices/procedures and applying industry best practices.
• Execute or review any data analysis required as delegated by Partners, such as trend reports or product reviews.
• Track and execute reports on metrics and compliance through the key quality indicators (KQI) on the applicable global platforms for Partners visibility.
• Responsible for opening, owning, managing, approving or following up (as applicable) the deviations and/or related child records, in accordance with company and regulatory requirements.
• Follow-up the status of actions arising from Quality Systems.
• Support as the Quality Expert in inspections (internal or external) related to GMP/GLP topics.
• Support on the oversight of laboratory operations as delegated or back-up of the QA manager for QC role, to ensure compliance with internal and regulatory requirements. Being responsible for:
• The review and approval of laboratory deviations and investigations.
• Support the laboratory to manage Data Integrity topics (e.g. DI Walkthrough reviews, DI plan commitment and promote DI culture).
• Administer the 1QEM system as a superuser in terms of access requests for profiles, profile registrations and deregistration or changes, and provide support during escalations to the global teams in 1QEM, in case of system failures.
• Reviews and approves validation protocols/reports, stability documents, specifications, work orders, change controls, SOPs and any other site product related to quality control documents aligned with his/her role, ensuring adequate level of documentation is present and compliant with existing procedures and regulations.

Key performance indicators:

• Ensure compliance with quality systems and corporate requirements.
• Support adherence for Quality KPIs.
• Zero critical findings in local, internal, and corporate Quality and Safety audits.
• Ensure adherence to the ALCOA + principles in routine activities
• Positive feedback from the parties involved in the processes under his/her responsibility.

Minimum Requirements:
Professional related to Chemical-Biological areas: Chemistry, Pharmacy, Biochemist, or related career.

At least 5 years’ experience in a Quality organization or equivalent.

Work Experience:

• Functional Breadth.
• QC/ QA in pharmaceutical ind./ biotech.
• Collaborating across boundaries.

Skills:

• Continuous Learning.
• Dealing With Ambiguity.
• GMP Procedures.
• QA (Quality Assurance).
• Quality Control (Qc) Testing.
• Quality Standards.
• Self Awareness.
• Technological Expertise.
• Technological Intelligence.

Languages :

• English.