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30/07 Dhara Thakkar
Freelancing Consultant at Consultant

Views:298 Applications:34 Rec. Actions:Recruiter Actions:22

Manager - Quality Control - Pharma (5-8 yrs)

Overseas/International/Morocco Job Code: 24243

JOB PURPOSE :

- To set up and establish quality management vision, to ensure that a Quality Management System is implemented that meets or exceeds the expectations of the Regulatory Bodies (cGMP).

- To set up goals for quality measures and methodologies and drive continuous improvement plans, through risk assessment, in order to ensure high quality across the wide range of products.

- Hiring appropriately skilled and trained staff in Quality Control for transformation objectives.

- Uphold and safeguard regulatory and quality compliance of all products tested and released at company Maroc.

- Take personal responsibility for finished product tested and released as per the cGMP requirement.

JOB DESCRIPTION :

- Overall responsibility of QC at company Maroc.

- Co-coordinating assigned functions within the Quality department.

- Ensure that finished drug products are manufactured and tested in a way that takes account of the requirements of cGMP (e.g. As per requirement of MOH Morocco) and those of good laboratory practice (GLP).

- Supervising RM, PM, bulk and finished product analysis.

- Monitoring and supervising equipment calibration related to QC

- Approval and Monitoring of suppliers of materials regarding QC.

- Ordering and purchasing consumables, reagents, Reference standards.

- Participate in Process validation.

- Participle in cleaning validation within the QA head.

- Responsible of handling of reserve samples.

- Responsible of implementation of specifications or SOP's related to RM, PM; Finished products.

- Responsible for Laboratory compliance of Regulatory inspection Observations.

- Ensure that pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements/ regulations.

- To assure that appropriate calibration and preventive maintenance of laboratory instruments are conducted as scheduled and record thereof is maintained.

- Monitoring of compliance with the requirements of Current Good Manufacturing Practices.

- To approve and monitor any contract analysis carried out as per contract and ensure that the testing is done as per cGMP / cGLP practices.

- Ensure strict adherence to safety, health and environment.

- Control and monitor technology transfer activities.

- Designation and monitoring of storage condition for materials and products.

- Monitoring of the IPQC of dosage forms, process control if any and bring it to the notice the concerned head of the department to take appropriate corrective and preventive action.

- To approve specifications, sampling instructions, test methods and other Quality Control procedures/documents.

- Authorization of written procedures (SOP's, Specifications, test methods, etc.,) related to Quality Control. To also ensure their adherence and strict implementation to the defined timelines.

- Monitoring and control of the manufacturing environment.

- Ensure validation and calibration of QC equipment /instruments are performed as per schedule.

- The designation monitoring of storage condition for materials and products/protection of products and materials against spoilage and deterioration.

- Ensure that all required materials and products are tested as per requirements.

- To ensure that the documents related to QC are properly stored & achieved on time wherever required.

- Responsible for Stability results review and approval, making sure that there is stability data to support retest or expiry dates and storage condition on drug substance, intermediate and drug product.

- To ensure that the validation of analytical procedures are carried out and ensure that all necessary testing is carried out.

- Ensure investigation of out of specification / out of trend are performed related to QC as per the defined time lines and ensure appropriate corrective and preventive action based on the results of investigation identified and implemented.

- Identification of training needs and imparting training with respect to cGMP, GLP, Safety, Hygiene related to QC. To ensure that the required initial and continuous training of department personnel are carried out and adopted according to the need in relation with QA Head.

- Responsible for Stability results review and approval, making sure that there is stability data to support retest or expiry dates and storage condition on drug substance, intermediate and drug product.

- To ensure that the validation of analytical procedures are carried out

- Review and approval the validation documents for the process / cleaning and equipment qualifications.

- To ensure that all process and cleaning validations are properly planned, executed and documented.

- Other assignments allocated by Responsible Pharmacist

SKILLS & KNOWLEDGE :

- 5 to 8 years of experience in a Quality Control Role which includes exposure in all sub -functions preferably in the Pharmaceutical Industry.

- Flexible and yet resilient, detail oriented and ability to drive a team through personal example.

QUALIFICATION :

- Qualification : Doctorate in chemistry or and higher scientific degree or equivalent

- Experience : 5 to 8 years

- Reportee : Analyst-QC

CORE SKILLS :

- Knowledge of quality management systems and good laboratory practices.

- Knowledge of setting up and establish QC lab operations

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