Head of Quality – Associate Director

Job Purpose
 
Lead all quality related functions on site and ensure the development and maintenance of quality during all manufacturing and product related activities.
The ensure compliance with all regulatory bodies (i.e. cGMP, SAHPRA, etc.)
 
Key Accountabilities
 
List the expected end results that must be achieved in order to fulfil the job purpose and the activities that help in achieving these results.
 
    • Overall responsibility of Quality Department at the company.
    • Co-coordinating assigned functions within the Quality department.
    • Responsible for periodic review of status of compliance of activities and keeping track.
    • Ensure that finished drug products are manufactured in a way that takes account of the requirements of cGMP (e.g. As per requirement of MCC, PICs, WHO etc.) and other associated codes such as those of good laboratory practice (GLP).
    • Investigation of recalled / withdrawal / returned products / complaints.
    • Participation in external audit (vendor audit), approval of vendor qualification documents.
    • Approval and Monitoring of suppliers of materials. Responsible for ensuring the deletion of Approved Supplier from Approved supplier list, BMR, QC Specifications and related documents in case of disapproval of the manufacturer.
    • Responsible for compliance of Regulatory inspection observations.
    • Critically examining, monitoring and control on manufacturing environment in view of minimizing product contamination.
    • 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 manufacturing equipment and laboratory instruments are conducted as scheduled and record thereof is maintained.
    • To review and approve the annual product quality report of all drug products and its relevant data / records to assure that products are meeting consistently quality standards.
    • To approve or reject starting materials, packaging materials, intermediate bulk and finished products in relations to their specification.
    • Monitoring of compliance with the requirements of Current Good Manufacturing Practices.
    • Notify concerned Quality Assurance person of the party/customer in case of any changes made / proposed in the product.
    • Conducting interviews of personnel as per requirements
    • Retention, supervision and motivation of personnel as per need.
    • To evaluate and approve/reject of any Reworking of products.
    • Review and approval of Technical Agreements.
    • 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.
    • Be notified of all circumstances which may affect the quality of products, whether before or after release for sale.
    • 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, online documentation, deviation if any and bring it to the notice of 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 Production, Quality Control, Quality Assurance, EHS, Engineering & Warehouse. To also ensure their adherence and strict implementation to the defined timelines.
    • Monitoring and control of the manufacturing environment.
    • Ensure Process validation and calibration 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.
    • Monitoring of compliance with the requirements of GMP.
    • The inspection, investigation and taking of samples in order to monitor factors which may affect the product quality.
    • To ensure that all required materials and products are tested as per requirements.
    • Responsible for maintaining the Site Master File.
    • To conduct the self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system. Also responsible for supervision of the regular internal audits or self-inspections.
    • Ensure process and procedure deviations and batch failures are appropriately performed and documented. Taking appropriate corrective and preventive action based on the results of investigation identified and implemented
    • Approval of batch documents, written procedures including amendments and control of soft and hard copies.
    • To ensure unit operations are conducted periodically, to update the existing SOP’s, specifications, test methods, work systems including risk assessment with respect to the current guidelines and as per registered documents.
    • To ensure that the documents are properly stored & achieved on time wherever required.
    • Evaluation and approval / rejection of change controls related to system, facility, product and document and study of impact related to changes.
    • To check the maintenance of department, premises and equipment.
    • Responsible to approve retention and destruction of documents and records as per SOP.
    • 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.
    • Monitor Plant hygiene/cleanliness
    • Responsible for conducting periodic Quality Management Review.
    • Evaluation, approval / rejection of change controls related to system, facility, product and document and study of impact related to changes.
    • Ensure investigation of out of specification / out of trend results are performed 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. To ensure that the required initial and continuous training of department personnel are carried out and adopted according to the need.
    • Active participation in validation programs.
    • Review and approval of the validation documents for the process / cleaning and equipment qualifications.
    • Responsible for establishment, implementation and maintenance of quality systems.
    • To ensure that all process and cleaning validations are properly planned, executed and documented.
    • Review and approval of qualification of new / modified areas / equipment’s and also ensure their re-qualification.
    • Review and approval of Quality Risk Management.
    • Any other assignment allocated by Director QA, Global Head QA or General Manager.
 
 
 
Key Interactions
 
Internal
 
    • Supply Chain
    • Stores
    • Production
    • HR
    • Finance
    • Engineering
    • Safety  
 
External
 
    • Regulatory agencies – need based– to gain updates on key products or guideline/regulatory changes; for audits
    • Techno-commercial partners/vendors – need-based – to enhance the partnership
 
Dimensions
 
    • Documentation related to Quality management documentation
    • Quality Policy and manual
    • SOP’s, Master batch records and
    • Specifications, Quality and Validation documents
 
Skills & Knowledge
 
Educational qualifications:
 
    • BSc degree or National Diploma in Scientific field
    • 10 years Management experience in a Pharmaceutical Industry
 
Skills
 
    • Sound knowledge of cGMP requirements
    • Relevant guidelines
    • Knowledge of Quality Management systems
    • Knowledge of statistical process control
    • Sound knowledge of basic Quality Assurance principles,
    • Computer literate (MS Office, Word, Excel, Outlook, PowerPoint, Syspro),
Good auditing skills