Review and approve electronic batch record (eBR), checklists and electronic logbook (elog) design on selected Manufacturing Execution System (MES).
Advise on user oriented compliant eBR, checklist and elogbook design.
Review and approve MES test scripts.
Ensure that all GMP processes and operational / manufacturing personnel comply with current local and area specific procedures.
Maintain a strong presence in the assigned operational areas, acting as the first point of contact for initial management of quality issues and be accountable for key quality decisions, including supporting initial impact assessment for deviations.
Provide real-time guidance during GMP activities to proactively identify potential quality risks through active on-the-floor observation, enabling timely intervention to prevent deviations and defects.
Authorise key processes such as product changeover activities, quality tag-outs of equipment and facilities, buffer and material release, and inspection lot usage decisions.
Conduct spot-checks across production, warehouse and laboratory areas to ensure compliance with GMP standards, covering activities such as production, testing, cleaning and equipment maintenance.
Perform real-time review of documentation and batch records to ensure content accuracy, appropriately handling of exceptions and adherence to Good Documentation Practices (GDP) aligned with ALCOA+ principles for data integrity, audit and traceability.
Verify that facilities are being maintained in a good state in line with local housekeeping standards and escalate any deviation from the standards promptly ensuring associated remedial and corrective actions are implemented in a timely manner.
Qualifications
Degree in Life Sciences (Chemistry, Biotechnology, or related field).
Experience in GMPregulated biopharmaceutical manufacturing.
Experience in Quality Operations (QO) and Manufacturing Quality Assurance (MQA) role for at least 1 year.
Experience in reviewing executed eBR and understand review by exception methodology.
At least has reviewed eBR / elog recipe revision.
Preferably with experience in MES implementation project.
Preferably with desire to pick up MES technical skills.
Preferably having experience in sterile processing.
Understanding of cGMP regulations and Pharmaceutical Quality System expectations.
Effective collaboration skills across multiple functions and departments.
Able to balance quality and business requirements.
What We Offer
Career development: we will work with you and the client to give you a wider exposure to prepare for career consulting career.
Teamwork: we deliver a service and not a manpower provider. You get a team to support you at your work and have fun together.
Learning opportunities: we offer continuous learning through structured planning and development.
Professional Environment: work with similar professionals possessing Intelligence, Resourcefulness, Loyalty and Teamwork.
