Job description of Quality Head.

This articles describes the job description of Quality Head for pharmaceutical industry

JOB DESCRIPTION OF QUALITY  HEAD

Responsibilities of Quality Head :

•To facilitate establishment, monitoring and maintaining of Quality management system as per applicable national & international regulations.
•To ensure facility has valid manufacturing license & product permission for manufacturing & distribution of drug products.
•To facilitate implementation of Quality Assurance systems during receipt of material, analysis, release & rejection, storage and their usage for manufacturing of finished products.
•To facilitate implementation of documents & data control system, retention policy & approve the key documents, standard operating procedures (SOPs), standard testing procedures (STPs), specifications, schedulers/planners, manuals, manufacturing records including amendments.
•To facilitate investigations such as market complaint, product /material failure, out of specification, deviation, stability failures & any other failures which can lead to failure of product & quality management system.
•To facilitate impact assessment, identification & implementation of corrective & preventative action for investigations carried out.
•To facilitate implementation of change management system.
•To facilitate the identification & arrangement of resources for analysis, release & rejection of starting, intermediate & finished products and stability studies in accordance with applicable specification, test procedure, technical agreement & authorized dossier.
•To facilitate design & implementation of system to ensure products, procedures, equipments, facilities & personnel are qualified & validated & will provide the desired results consistently.
•To facilitate implementation of supplier management system & review the supplier performance periodically.
•To ensure TSE (Transmissible Spongiform Encephalopathy) status of all materials used in the manufacture is compliant with the terms of authorization.
•To facilitate technology transfer of manufacturing & analytical technology of new products from formulation & developments (F&D) department, MA holder and / or product development laboratory.
•To ensure any post marketing commitments relating to manufacture or testing of the product in the authorization have been addressed & ongoing stability data continues to support certification.
•To ensure relevant documents & information are provided reasonably to regulatory departments, MA holder and / or product development laboratory for preparation of dossier / registration of products.
•To facilitate, artwork development, review, approval & release system as per the national & international legislation / MA holder requirement & restrict usage of any obsolete / outdated artwork.
•To facilitate implementation of training & development procedure for continual development of personnel, practices, procedures & quality systems.
•To report any technical /quality /administrative issues to senior management.
•To ensure all audits has been carried out as required.
•Batch Release and Certification (responsibility delegated to Asst. QA Manager / deputy QP)
•To ensure that each batch of finished product has been manufactured & checked as per applicable legislation / GMP and the marketing authorization (MA).
•To ensure principal manufacturing & testing procedures are validated, account has been taken of the actual production conditions and manufacturing records.
•To ensure any deviations or planned changes in production or quality control have been authorized as per defined system. Any changes requiring variation to the marketing authorization have been notified to and authorized by the relevant authority.
•To ensure that the API used in manufacturing of the finished product have been manufactured in accordance with GMP and imported and distributed in accordance with GDP.
•To evaluate impact of any change to product manufacturing or testing has been evaluated and any additional checks are complete.
To ensure batch records and analytical records are completed, reviewed and any investigation have been completed to a sufficient level by authorized person before release / rejects of finished goods.
•To ensure the storage condition of finished product is maintained as per product dossier / MA & shall be distributed under prescribed storage condition.
•In case of partial distribution of released batches, it shall be ensured all part quantity is stored & transported under the similar condition & the samples tested are representative of whole batch.
•Should maintain the knowledge & experience up to date in the light of technical & scientific progress & changes in quality management relevant to the products to be certified.
•To facilitate selection of contract agencies, identification of contract service & evaluation of contract agencies as per applicable legislations.
•To establish Internal and External inspection management system to ensure established system are followed at all level & to identify any scope of improvement in the existing system and identification & implementation of appropriate CAPA.
•To facilitate GAP analysis of procedure & practices to keep them updated as per cGMP.
•To perform assessment of critical complaints & adverse drug reaction & execute the product recall operation as & when required & handle the market returned products.
•To facilitate implementation of safety, health & environment (SHE) policy.
•To ensure adequate resources, manpower & budget is provided to QA & QC departments for performing their responsibility correctly.
•To participate in management review of process performance, product quality and of the quality management system & advocating continual improvement & update in compliance with applicable national & international regulations.
•To facilitate monitoring & control of the manufacturing environment & plant hygiene.
•To ensure establishment of timely & effective communication and escalation process to raise quality issues to the appropriate levels of management.
•The responsibility is not limited to above & any other responsibility can be performed by the incumbent as delegated / assigned by superior from time to time.
•Any responsibility delegated to incumbent can be further delegated under supervision to his deputy.