Job Responsibilities of Quality Assurance

1.0 PURPOSE:

To define the procedure of Job Responsibilities of Quality Assurance at Unit level.

2.0 SCOPE:

This procedure is applicable to Quality Assurance department at (Company name).

3.0 DEFINITION:

An order to effectively manage your staff, it is important to provide them with a clear definition and understanding of their role, function, and responsibilities in the workplace. This will provide them with a good understanding of the job and tasks they are to perform as an individual and within any teams they are a part of. It also provides information on where they fit within the organization and who they report to, helping to avoid disputes and misunderstandings over authority.

4.0 RESPONSIBILITY:

All Quality Assurance Staff as Per Designation.

5.0 PROCEDURE:

Job Responsibility of Quality Assurance are as follows: 
5.1 Creating quality systems and procedures.
5.2 Authorizing key procedures.
5.3 Reviewing and Approval of specifications and test methods.
5.4 Reviewing vendor quality management.
5.5 Interacting with product development and manufacturing personnel to validate processes with procedures.
5.6 Interacting with manufacturing and engineering personnel in planning for the construction, alteration, renovation of premises, plant or equipment
5.7 Interacting the personnel of other departments concerned with the development of electronic data processing systems, wherever these are concerned with materials or products.
5.8 Evaluating Deviation and fault Reports and Complaints.
5.9 Improving in-process controls.
5.10 Critically examining the environment with a view to minimizing product contamination.
5.11 Ensuring that goods are produced according to protocols accepted for registrations.
5.12 Be notified of all circumstances which may affect the quality products. Whether before or release for sale.
5.13 Having the final responsibility to management for release or rejection of all materials and products subjected to the quality control system.
5.14 Be empowered to take the samples for testing from any material or substances relevant to product quality.
5.15 Establish or approve re-processing or re-working products.
5.16 Establish or approve standard operating procedures relevant to or affecting product quality.
5.17 Evaluate any re-processing or re-working of products.
5.18 Assemble and review all documentation relating to the reprocessing, packaging and testing of each batch of product before authorizing release for sale.
5.19 Participate in the investigation of devotions discrepancies or test failure.
5.20 Evaluate complaints relating to product quality received from any source.
5.21 Review periodically the records relating to each product and report on compliance standards, problems if any and recommended action.
5.22 Periodic review of all quality functions and procedure for appropriateness and validity.
5.23 Examine returned goods, to determine whether they should be released, reprocessed or destroyed.
5.24 Deviations are adequately recorded, investigated and responded to.
5.25 The head of Quality Assurance should be part of the decision making process in all matters that affect the quality of product including development, production, laboratory, storage, distribution and vendors.
5.26 Ensure that pharmaceuticals products are designed and development in a way that takes account of the requirements of cGMP and other associated codes such as GLP.
5.27 Responsible to maintain all necessary controls on starting materials. Intermediates products and bulk products and other in process controls. Calibration and validations are carried out.
5.28 Ensure that pharmaceuticals products are not sold or supplies before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing and authorization and any other regulations relevant to the production, control and release of Pharmaceuticals products.
5.29 Conducting regular self-inspections or internal quality audits to assess the effectiveness and relevance of the quality assurance system.
5.30 To fulfill the training need as per current needs with respected GMP, GLP. Safety and Hygiene.
5.31 Preparation of APQR.
5.32 Preparation and review of Quality risk management.
5.33 Review and approval of Master batch records before execution.
5.34 To check and verify calculation of materials to be dispensed for manufacturing.
5.35 To conduct in process checks as per BMR/BPR and record results.
5.36 Conducting Acceptable Quality Level (AQL) inspection.
5.37 Conducting the Qualification and requalification activity.
5.38 Responsible for preparation, review and approval of site master file (SMF) and validation master plan (VMP).
5.39 To conduct management review meeting as per SOP.
5.40 To ensure appropriate agreement are place with the customers and external laboratories and they are updated timely.
5.41 Review and approval of trends/summaries of environment and water.
5.42 Responsible for review of tech transfer activities.
5.43 Review and approve/reject the artworks including proofs of printed packing materials.
5.44 Sampling of in process and finished product.
5.45 Maintain Stability sample and Retain Sample Record.
5.46 Responsible for review of regular batches COA and all analytical documents.
5.47 Responsible for review & approval of method verification/transfer.
5.48 Any other assignment allocated by Department Head.

6.0 ABBREVIATIONS:

cGMP : Current Good Manufacturing Practice
GLP : Good Laboratory Practice
APQR :Annual Product Quality Review.

7.0 ENCLOSURES:

Nil

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