Site Quality Manager Job Description
Site Quality Manager Duties & Responsibilities
To write an effective site quality manager job description, begin by listing detailed duties, responsibilities and expectations. We have included site quality manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Site Quality Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Site Quality Manager
List any licenses or certifications required by the position: ISO, CWI, AWS, II, NDT, ASQ, 9000, QMS, 9001, ISO13485
Education for Site Quality Manager
Typically a job would require a certain level of education.
Employers hiring for the site quality manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Technical, Science, Business, Manufacturing, Management, Chemistry, Education, Biological Sciences, Medical
Skills for Site Quality Manager
Desired skills for site quality manager include:
Desired experience for site quality manager includes:
Site Quality Manager Examples
Site Quality Manager Job Description
- Ensure that the technical design is consistent with other modules and reusing the FRA shared component
- Participate in recruitment of Business Analyst and Quality Analysts for the Revenue Accounting team
- Responsible for the Knowledge Transfer and training of the new team(s) in Bangalore on technical and process related aspects around development cycle
- Ensure good communication and integration of the RA team in Bangalore with the teams in Sophia Antipolis
- Contribute to preparation of budget for division and follow-up
- Performance Management, Career Management and day-to-day management of FRA team
- Identify and implement opportunities for functional ownership in FRA at Bangalore
- Define overall test strategy
- Accompany and support the customer during UAT for all testing matters
- Responsible for the setting of the test environment during UAT (rehearsal and training environments set-up is out of scope)
- Follow the results of the test campaigns performed by the Quality /test Engineers
- Provide the appropriate sign off for functional, non-functional and non-regression validations between each phase of the life cycle (integration, system, and acceptance)
- Follow-up issues and trigger actions to ensure sustainability of the product
- Responsible for the monitoring of the software quality KPIs over the different testing phases
- Deliver regular reports to QA, BA and DEV teams on the evolution of the quality along the testing phases
- Strong interpersonal and communication skills with service oriented mind
Site Quality Manager Job Description
- Lead the risk analysis team
- Ensure cGMP rules adapted to our business are implemented, respected
- Manage documents into GMS
- Responsible for GMP and IPC training, and responsible training efficiency
- Ensure customers requirements are well defined
- Lead customer complaints (CAPA), CAPA team
- Is independent from production (functional link with the head of Quality)
- Lead customer audits, and is responsible for audits follow up (CAPA)
- Lead improvements and ensure that root cause analysis methodology is well applied
- Manage and document handling of returns and restricted materials
- Sense of initiative, autonomy and ability to set priorities
- Is the site management representative
- Escalate a risk of recall to upper management and the criteria for recall
- Can escalate any issue (internal or external) to the upper management (head of quality)
- Lead and coach QA/QC team
- Is responsible for people development (evaluation, training, talent identification…)
Site Quality Manager Job Description
- Coordinate regulatory affairs with Product Stewardship for the plant
- Review and approve supplier/Subcontractor quality documents or delegate to proper review and assure they get to the project teams as needed
- Lead and develop staff within the function to a high level of competency and performance
- Periodical quality and performance audits for guaranteeing the food safety and the transfer of the R.C
- Prepare and recommend scientifically valid and appropriate quality assurance measures for technical assignment, data collection activities
- Provides technical supervision and assistance to insure project activities are technically valid and results are coordinated for project continuity and control
- Manage the industrial Quality Team in order to ensure the deliveries from the Site are at the right quality level
- Guarantee the compliance of the purchased & manufactured products
- Validate manufacturing control plans
- Measure the quality produced by the manufacturing process
- M-Pharm or related
- 15 years experience in Quality Control & Quality Assurance in the Pharma or related Industry
- Well conversant with USFDA regulations
- Knowledge of Tamil is a must
- NDE Certification with 12 to 15 years’ field experience
- A minimum of 5 - 10 years of work experience in Fabrication or Construction in Hydro Carbon Industry
Site Quality Manager Job Description
- Lead site GMP audits in accordance with approved procedures and applicable standards and regulations
- Lead the development and implementation of CAPA following audit program completion
- Lead the compilation of quality metrics related to audits for dissemination at Quality Council and Management Review
- Lead in company and site preparations for support of regulatory and customer inspections
- Provide compliance advice to development and commercial product teams
- Supports and continually enhances the ongoing site Permanent Inspection Readiness status
- Lead effective change management for Audit CAPA delivery
- Lead resolution of Supplier Quality issues to assure compliance and a flow of high Quality materials
- Reports to the site Quality Director and participates as part of the site Quality Leadership Team
- Define scope and support/coach improvement projects (PDCA, 8D, RCA, A3, DMAIC, VSM)
- Bachelor’s degree in Nursing, biological sciences, nursing, medical technologist or related field
- Minimum of 8 years progressive experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, preferred
- Medical center or pharmaceutical auditing experience preferred
- Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred
- Previous experience presenting and responding to regulatory agency or certification audits, preferred
- Bachelor’s Degree in a Scientific/Technical field
Site Quality Manager Job Description
- Support and maintain Quality Agreements with suppliers to ensure an appropriate GMP level and other process related requirements
- Supplier qualification in alignment with Purchasing and Marketing functions
- Maintain product specifications with suppliers
- Set up the LIMS configuration to ensure batch release process and the generation of Certificates of Analysis
- Set up and maintain product risk assessments
- Batch releases for SSP
- Investigate customer complaints in alignment with suppliers, initiate CAPA at DNP and/or on supplier's side
- Responsible for Change Control (MoC) and customer notifications related to SSP
- Support and give input for annual supplier evaluation with Purchasing and Marketing functions
- Establish and maintain FAQs per product/supplier to support regions for 1st level customer request and answer customer questionnaires as 2nd level support
- Develop, implement and maintain the HACCP and OPRP programs
- Insure GMP-GHP
- Update Flowchart and Hazard Analysis
- Analysis of results for internal and external audits
- Manage no-conformities (decide, put on hold, isolate, destruct), analyze for root causes and undertake correctives actions
- Leads the Food Safety Team (HACCP team)