Quality Assurance Operation Supervisor İş İlanı
İşveren Hakkında
- Ankara
- İlaç Sanayi
GENEL NİTELİKLER
This position will be based at our Ankara Vilsan Site.
Implements the overall quality strategy for the facility at the plant shopfloor level. Partners with the Head of Quality Operations and Senior Leadership Team to ensure alignment with Manufacturing and support functions in executing the strategy.
Batch Release:
- Responsibility includes release of finished product batches to domestic and export market.
- Informs Site Quality Head of critical issues in a timely manner.
- Acts as the lead SME for significant quality or compliance issues within the Manufacturing facility.
- Develops, directs, and maintains quality on-the-floor staff to support manufacturing in a manner consistent with global quality systems requirements AHQM and current regulatory requirements, and others as needed.
- Oversees all aspects of QA operations within the facility, including but not limited to executed batch record review, on the floor QA support, material release, deviation investigations, change controls, customer quality support and SOP and master batch record review.
- Routinely reviews regulatory correspondence/audit reports and assures compliance of QA Release procedures.
- Performs 2nd review/release approval of finished product batches
- Initiates non-conformance reports for batches that do not meet requirements.
- Routinely reviews specifications/ standards/ inspection plans for compliance to current regulatory requirements.
Deviations/CAPA:
- Initiates deviations in Quality electronic systems when non-conformances are detected during documentation review.
- Assesses, reviews and approves deviations (department approver) and assigns investigations as needed.
- Writes or participates in deviation investigations for determination of appropriate root causes.
- Serves as QA approver for investigations as needed.
- Performs follow-up on CAPAs for completion.
SAP:
- Performs movement transactions in SAP system of product as needed.
- Performs usage decisions for batch release in SAP
- Performs second check in SAP prior to batch release.
- Reviews and approves Certificates of Analysis and Certificates of Conformance for batch release.
- Create and update export documentation as changes occur
QA processes;
- Develops training plans and trains others, including training outside of area of responsibility.
- Performs assessment and approvals of requests for items that are returned to stock.
- Builds and maintains expertise in the QA Ops teams, including development of staff.
- Applies manufacturing experience to ensure that operations meet customer and regulatory expectations and requirements for manufacturing site.
- Provide leadership and management for the quality function and sustain the quality philosophy and lean culture at plant level.
- Establish, maintain and optimize an effective quality management system.
- Communicates regulatory and organizational requirements to assure product quality and compliance
- Coordinates necessary plant personnel for internal, customer and third party quality system audits.
- Maintains a corrective action system to analyze and correct nonconforming conditions and events.
- Uses the results of performance evaluation to target improvement efforts.
- Ensures QA support for internal and external project and team meetings.
- Support Product Quality Reviews,Change Control, Regulatory Audits, Trainings Program as needed
- Define and implement QA processes like release criteria/scheduling lot release on time, KPIs
- Actively participates on project teams as assigned by Site Quality Head
- Coordinates and leads projects within group without supervision
- Perform other duties as assigned.
Education & Experience:
- Bachelor's in Science or related technical field
- At least 5 years of related experience in the Quality Unit
- Extensive exposure to cGMP environment
Knowledge, Skills, Abilities:
- Strong organizational and time management skills
- Prioritization and problem-solving skills
- Strong knowledge of Quality procedures, processes and guidelines
- Recognized by colleagues as a source of expertise
- Strong interpersonal and communications skills; written and oral
- Understanding of applicable regulatory requirements
Physical Demands/Factors:
While performing the duties of this job, the employee:
- Must demonstrate excellent organization and time management skills
- Needs ability to aseptically gown and/or sterile gown as needed
- Has the ability to function in a dynamic environment and balance multiple priorities simultaneously
