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JOB RESPONSIBILITY
Name: Department: Quality Assurance
Designation: Quality Assurance Lead Area/Lab/Section: Quality Assurance
1. General Instructions:
1.1. Each individual shall
undertake the said duties but has to work alongwith the team in order to assume
collective responsibilities. Individual adventurism of any sort is not
encouraged.
1.2. Any deviation
observed during discharge of official duties is to be reported to the superiors
immediately.
1.3. Any person working in
shifts has the additional responsibility of briefing the personnel working in
the next shift about the work done and that to be undertaken subsequently.
1.4. Addition or
deprivation of duties and responsibilities shall depend on the performance of
the individual.
2. Duties/Responsibilities:
2.1.
QA
In charge shall ensure Quality Management System shall be established,
documented, implemented and maintained and continually improve for its
effectiveness in accordance to require standards.
2.2.
Shall
identify the statutory and regulatory requirements applicable to all the
products manufactured in the plant and shall ensure that these requirements are
met.
2.3.
Shall
identify all the processes falling under company’s QMS and identify their
sequence of interactions. Shall also ensure that all the processes meet latest
GXP requirements.
2.4.
Shall
review and submit all the documents and dossiers required by the state, zonal,
national and international regulatory departments.
2.5.
Shall
ensure that there is proper organization of documentation system and all the
documents are segregated and prepared as per the hierarchy document system
(level 1, 2, 3 and 4 documents).
2.6.
Ensure
that the documents are periodically reviewed and updated.
2.7.
Shall
establish and maintain quality manual, define quality policy and establish
quality objectives.
2.8.
Shall
ensure that Level 2 documents (policies and plans) are established as per the
latest requirements and ensure their implementation at all the levels of
Quality System.
2.9.
Shall
ensure that level 3 (Standard operating procedures) and level 4 (records, test
methods, specifications, validations) are prepared and implemented in all the
departments of the quality management system.
2.10.
Shall
ensure that effectiveness of QMS is continually improved through the use of the
quality policy, quality objectives, audit results, analysis of data, corrective
and preventive actions and management review.
2.11.
Shall
ensure that the integrity of the quality management system is maintained when
changes to the quality management system or its components are planned and
implemented.
2.12.
Shall
ensure that the procedure for root cause analysis, corrective action and
preventive action are in place and are effectively implemented.
2.13.
Shall
review and authorize all the documents and records pertaining to the quality of
the product and QMS.
2.14.
Shall
review and authorize summary protocols of all the production batches.
2.15.
Shall
authorize release of intermediate, drug substance and drug product.
2.16.
Shall
authorize manufacture of the batch as per the production plan and ensure that
manufacturing is done as per the set procedures and specifications so that the
product meets its desired specifications.
2.17.
Shall facilitate internal, external and
regulatory audits and inspection and shall all the audit points and suggestions
are complied within the stipulated time period.
2.18.
Shall ensure that all the market
complaints are investigated and resolved as per the national regulatory
guidelines and facilitate product recall if any as per the set guidelines.
2.19.
Shall ensure that suitable methods for
monitoring and, where applicable, measurement of the quality management system
processes are in place.
2.20.
Shall ensure that the characteristics
of the product are monitor and measure to verify that product requirements have
been met.
2.21.
Shall ensure that product which does
not conform to product requirements is identified and controlled to prevent its
unintended use or delivery.
2.22.
Shall ensure that top management shall
review the organization's quality management system, at planned intervals, to
ensure its continuing suitability, adequacy and effectiveness.
2.23.
Shall ensure that all the staff
involved in manufacturing, control and testing and support functions are
competent on the basis of appropriate education, training, skills and
experience. The staff shall be trained in the aspects of job function, hygiene,
GXP and other areas deemed necessary.
2.24.
Shall ensure that all the quality
assurance functions are planned and executed accordingly.
2.25.
Shall ensure that the procedure of
vendor approval is in place and all the material and services taken by the
organization shall follow this approval process. List of approved vendors shall
be prepared.
2.26.
Shall ensure that proper control is
there on all the outsourced activities and shall be within the umbrella of
quality management system.
2.27.
Assign job responsibilities to Quality
Assurance staff.
2.28.
Undertake other duties as determined by
superiors.
3. Authorities:
3.1.
Authorize
initiation of production batch.
3.2.
Authorize
final release, distribution and recall of various products of the company in
the market.
3.3.
Authorize
distribution and control of various audits documents for Registration, License
and Tendering purpose.
3.4.
Authorize
investigation for process / product complaints for non-conformity.
3.5.
Approval
of various Quality related policies of the company.
3.6.
Authorize
all the documents prepared as per the hierarchy document system (level 1, 2, 3
and 4 documents).
4. Reporting:
4.1.
Report
to plant head/ factory manager all the daily activities and plans.
Assigned
By CMD
(Signature
and Date)
Jobholder
(Signature
and Date)
"pcb assembly,
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