JOB RESPONSIBILITY
Name: Department:
Quality
Control
Designation: Quality Control Lead Area/Lab/Section: Quality Control
1. General Instructions:
1.1. Each individual shall
undertake the said duties but has to work along with 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. To supervise the
overall administration of the QC Department.
2.2. Issuance of
certificate of analysis (COA) of the finished product for market release.
2.3. To ensure that
specifications for all the starting materials, raw materials, reagents,
solutions, intermediates, drug substance and drug product are laid down.
2.4. To ensure that the
specifications are established keeping in mind the product requirements,
statutory and regulatory requirements including pharmacopeial requirements and
are scientifically sound and appropriate to so that raw materials,
intermediates, APIs, and labels and packaging materials conform to established
standards of quality and/or purity.
2.5. To ensure that
sampling plans and procedures are in place for all the raw materials,
intermediates, drug substance, drug product and labels and packaging material
are in place and followed without fail.
2.6. To ensure that all
the raw materials, intermediates, drug substance, drug product and labels and
packaging material are tested before release.
2.7. To ensure that all
the testing procedures pertaining to raw materials, intermediates, drug
substance, drug product and labels and packaging material are in place. The
procedures are scientifically sound and appropriate. Ensure that all the
pharmacopeial testing procedures shall be as per the latest version of the
pharmacopeia.
2.8. To ensure that raw
data and test reports are archived as per the document archive policy.
2.9. To ensure that all
the analytical methods used for the raw materials, intermediates, drug
substance, drug product are validated as per the laid standards.
2.10. To ensure that
release of raw materials, packing materials, In-process and finished product is
performed as per the laid down standard.
2.11. To ensure that the source
of each primary reference standard is documented and standard stored as per the
recommendations. Ensure that Secondary reference standards are appropriately
prepared, identified, tested, approved, and stored.
2.12. Each batch of
secondary reference standard is periodically requalified in accordance with a
written protocol.
2.13. To ensure that cell
bank of all the reference strains of microorganism used in QC department are
maintained in accordance with the laid procedures.
2.14. To ensure that
environmental monitoring plan is in place and updated. All the EMP activities
are performed as per the plan.
2.15. Review of various
trend analysis of environmental parameters and process parameters.
2.16. To ensure that any
out-of-specification (OOS) and out of trend (OOT) result obtained are
investigated and documented according to a procedure laid.
2.17. To ensure that
documented, on-going testing program should be designed to monitor the
stability characteristics of intermediate, drug substance and drug product, and
the results should be used to confirm appropriate storage conditions and retest
or expiry dates. The test procedures used in stability testing are validated
and are stability indicating.
2.18. To ensure that all
reserve sample and stability samples are stored in the same packaging system in
which the original product is stored or in one that is equivalent to or more
protective.
2.19. To ensure that testing of market complaint samples and
product recall samples is initiated as per the laid procedures.
2.20. To ensure that all the equipments and instruments used in
the quality control department are qualified and calibrates as per the laid
down criteria.
2.21. To ensure proper control over the outsourced testing review
and analyse the results reported by the outsourced testing laboratory.
2.22. To ensure that all the tests performed on the animals are
approved by the animal ethical committee.
2.23. To access training needs of QC staff. To impart or arrange
for all the trainings needed by QC staff.
2.24. To be a part of
self-inspection and quality audit team.
2.25. Assign job responsibilities
to QC staff.
2.26. Undertake other
duties as determined by superiors.
3. Authorities:
3.1. Authorize initiation
of various testing activities.
3.2. Authorize
investigations of deviations in analytical methods.
3.3. Authorize approval of
raw material, packing material, in-process samples.
3.4. Authorize release for
drug substance and drug product.
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)
