QA/QC Head & RA Head - India

1.  responsible for approval of all SOP’s, BMR’s and protocols, reports, specifications, test methods, qualification, etc.
2.     Responsible for approval of protocols/ reports/ corrective actions related to annual product review.
3.            Responsible for approval of reprocess and reworking of materials.
4.            Responsible for approval of vendors for raw material and packing materials.
5.            Responsible for approval of vendors.
6.            Responsible to ensure that consultant have appropriate experience/qualification and training.
7.            Responsible to ensure that records of consultants name, address, qualification and services are available
8.            Responsible to ensure that QC has performed stability of API/Intermediates.
9.            Responsible to ensure that the raw material and API are stored and transported in appropriate storage conditions.
10.        Responsible to ensure that calibration of equipments, instruments and measuring equipments is done.
11.        Responsible for approval/rejection of all changes in plant, machines, testing buildings and processes.
12.        Responsible to ensure the implementations of corrective actions found during the investigation of deviation and inspections.
13.        Responsible to ensure the procedures related to purchase, Production, engineering, services, maintenance, cleaning, calibration, dispensing, reject handling, OOS and distribution etc are in place.
14.        Responsible to ensure that records of all quality related activities are maintained.
15.        Responsible to ensure the routine QA inspections and selection of auditors.
16.        Responsible to ensure the training of all employees with coordination of personnel department.
17.        Responsible for conducting the customer and regulatory audits and corrective actions/response to them.
18.        Responsible to ensure that unique batch numbering system/other identification numbering system.
19.  Responsible to ensure the validation of equipments, air handling systems and water systems.
20.     Responsible to ensure the investigation of complains/product recalls/returns.
21. Responsible for final review, release or rejection of finished product/intermediates foe dispatch.
22.        Responsible for internal audit of all departments.
23.        Responsible to ensure the response to regulatory bodies.
 24.        Responsible to ensure the response to customers.

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