Quality Control Manager - Pharma
Quality Control Manager - Pharma
Posted on :
20-12-2024
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1 Vacancy
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Job Description
QC Manager
Experience: 8 15 Years
Location: Iraq City: Sulaymaniyah
Directorate/Dept.: Quality Control Department
Reports To: Quality Manager
Job Profile/ Summary:
(Briefly summarize your job)
The duties assigned to this job could be summarized in: Quality control Manager in charge to control and manage all processes running in all section of QC to ensure that all results are reliable traceable and dependable.
Quality system implementation according to ISO Pharmacopeia and GLP requirements.
Job Responsibilities & Authorities:
Freedom to act / Job Scope:
(The potential impact an individual job holder may have on the entire organization)
Ensuring the required quality impartiality and independence of testing services and the work in the Laboratory within the references and regulations framework.
Ensuring that QC personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the quality management system.
Overall planning and budgeting including approving technical and human resources and monitoring the costs of the Laboratory.
Approving internal documents i.e. management technical standard operating procedures and work instructions.
Evaluating the potential needs for document development and change.
Provision of the necessary external documents such as standards regulations etc.
Evaluating and approving general training needs and training methods providers timings and durations.
Ensuring the proper internal environmental conditions within the Laboratory and managing actions performed regarding this issue.
Taking equipment out of service temporarily or permanently and putting them back as applicable.
Coordinating interlaboratory comparisons and proficiency testing.
Following external calibration plan with calibration department.
Evaluating the potential needs for corrective and preventive actions.
Ensuring the highest safety levels in the Laboratory.
Resuming work in the Laboratory when an OOS is identified and the work is halted.
Checking and signing as approved by on the test reports.
Ensuring that the Quality management system is implemented maintained and understood by all QC personnel.
Ensuring that appropriate communication processes are established within the entire Laboratory and that communication takes place regarding the effectiveness of the Quality management system.
Following observations of internal and external audits reports related to QC.
Coordinating the equipment control process within QC and Identifying the needs for new equipment and determining their specifications and the documentation requirements.
Control of QC records and retained samples.
Supervision Exercised (Supervision of people & Function):
(May include level & type of work supervised the level and number of employees directly and indirectly supervised or the incumbent s role in directing and controlling a function)
No Supervision Staff 31 & ; More
Complexity & Judgment of the job:
Complexity:
(How difficult or easy the job is i.e. the variability of assignments the availability of guidance or direction and the time frame under consideration to complete the duties)
Working in QC is required to consider all factors that have a direct or an indirect impact on the results of tests such as chemicals preparation environment and equipment.
Physical Efforts:
(Muscular strains and discomforts arising from the work) Visual Concentration:
Involve standing and walking in all sections/units at Quality Control.
Visual Concentration:
(Possible eyestrain and fatigue that might arise from focused visual concentrations in order to read recognize defects or identify patterns)
Using PC Microsoft office and ERP system.
This position needs massive reading references external documents and reports.
Working Condition:
(The physical discomforts associated with the environment in which the job is customarily performed)
Mainly present in the labs of Quality Control involving Micro lab in IV Production department.
Knowledge & Experience:
(Achieved through formal academic on the job training selfeducation progressive working experience or/and specialized knowledge required across different functions and details about a particular area)
B.S. Masters PHD
Education & Experience:
6.1 B.Sc. in Chemistry Pharmacy or Biology or an intermediate institute degree.
Minimum 8 years Have worked in generic pharmaceutical factories .And in oncology factories (finished formulation) for at least 5 years.
Good background in basic chemistry biology and theory of analytical techniques.
Skills:
Good English skills in speaking and writing.
Good knowledge in Quality Systems.
Good skills in Microsoft office basics.
Good communication skills.
Employee Name: Employee Signature: Supervisor Review: Manager Approval: Effective Date:
english language proficiency,glp requirements,communication,technical writing,training coordination,quality systems,budgeting,calibration,english proficiency,good communication,iso standards,microsoft office,analytical techniques,communication skills,management system,quality control,chemistry,pharmacopeia
Employment Type
Full Time
Company Industry
Key Skills
- Laboratory Experience
- Quality Assurance
- Construction Experience
- FDA Regulations
- ISO 9001
- Assays
- Quality Systems
- Quality Control
- Quality Management
- cGMP
- QA/QC
- HACCP
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