Purpose Performs QC assignments for quality systems, processes and controls.
Accountable for contribution to ensure that objectives are effectively achieved, consistent with client requirements to ensure compliance, safety & reliable customer supply.
Responds to Operational and business area's, ensuring compliance with cGMP and corporate regulations.
Support the performance of the site cGMP activities.
Responsibilities Comply with and execute CGMP/GDP in the performance of day-to-day business activities.
Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities.
Escalate any potential violation of CGMP Participate in driving a high performing & inclusive culture, stimulating personal growth & development.
Liaise with the Quality/ Business Area Specialists/QC Leads) to resolve quality related queries where required.
Ensure that adequate processes and procedures are in place and followed for all Quality activities.
Where required work shift patterns in line with manufacturing operations to ensure Quality operations (including testing, delivery and or oversight) as required as per business needs & if needed.
Provide support to the relevant support functions to ensure manufacturing and release of vaccine and biologic prodcuts activities, in compliance with applicable procedures, our Company's Global Policies and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP).
Support business critical projects related to the Quality Department.
Use MPS principles and tools to identify and support continuous improvement by active participation to ensure quality systems and work practices are effective, efficient and ensure compliance and overall operational efficiency for batch and material release at the site where required.
Provide quality support of controls and procedures for the end to end material and product lifecycle where required.
Perform laboratory testing and / or materials inspections to determine specification conformance.
Perform all required analytical, microbiological and control testing to support the site.
Execute/Review /Support deviation/ CAPA activities, complaints, data integrity, Material Qualification, Validation, Quality Risk Management processes and other documentation including generation, investigation, documentation, implementation, verification closure, effectiveness and supporting trending where required for the Quality department and supporting functions.
Review of all manufacturing batch/ material documentation including (but not limited to) electronic batch records, real time reports, master data using the Quality (Control) systems where required.
Review of, SOP's, GMP data and other documents as necessary for the Quality department where required Contribute to effective writing/revising/rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems Support internal and external audits and inspections, ensuring department compliance/readiness.
Provide quality support to the qualification/validation, technical transfers and commercial operations at the facility where required.
Qualifications Bachelors degree (or equivalent) in a scientific discipline (e.g., Chemistry, Biology, Biochemistry, Microbiology, Pharmaceutical Science, or related field).
Experience working in a regulated environment with knowledge of cGMP and GDP principles.
Ability to perform laboratory testing and/or documentation review with strong attention to detail and accuracy.
Strong organisational, problem-solving, and communication skills.
Ability to work effectively both independently and in cross-functional teams.
Proficiency in standard business software (e.g., Microsoft Office).
Skills: QC Operational quality systems