Senior Level Job openings at Zydus Cadila for Deputy Manager-Quality Compliance(Chemistry) and Dy. General Manager – Quality Control (Leadership Role Holder Position)
Organization Zydus Hospira Oncology Pvt. Ltd.
Title: Deputy Manager-Quality Compliance(Chemistry)
Location: Pharmez – SEZ ,Ahmedabad.
Essential Qualification: Msc/B.Pharm
Total Number of years of experience: 5-8 years and above in Quality Control Chemistry department at manufacturing sites supplying to US , Europe markets.
Must have a sound knowledge of cGMP requirements from Quality compliance perspective.
Preferred Age Group: Between 25 – 32 years
To initiate and investigate the OOS results and to ensure the timely closure of the investigations.
To initiate and investigate the Deviation reports and to ensure the timely· closure of the document. Trending and review of analytical data and OOS results.
- To conduct the analyst’s qualification and to review the documents generated· thereafter.
To initiate the CAPA applicable for chemistry section.
- To initiate and review of the change controls.
- To carry out the method transfer / method verification /method validation testing and to document them according to the approved procedures.
To initiate and investigate the exceptions observed during the method transfer/ method Verification activities.
To review the method validation, method transfer, method verification· documents. To approve the documents in the absence of Head QC.
To carry out the investigational testing and to record all the data ensuring the traceability of it.
To ensure the integrity of the laboratory data.
To review the specifications, test methods, SOP’s, Protocols, Reports and LIMS masters as per the requirements.
To review the documents generated during the testing of Packing materials, Raw Materials, In-process, finished product, stability samples, miscellaneous materials and working standards.
To ensure that the testing is performed in compliance with the approved procedures.
To intimate Manager Quality Assurance / Manager Quality Control for any abnormality/failure during the testing.
However in absence of them intimating the status of the same to Head Quality and perform experiments if required.
To conduct the internal audits.
To perform the gap assessment between the current documents and the practices.
Assessment of the compendia compliance.
Audit compliance, follow up and completion of the same.
Organization Cadila Healthcare Limited
Title: Dy. General Manager – Quality Control (Leadership Role Holder Position)
Location: Dabhasa, Vadodara
Job Summary: To head Quality Control of API – Dabhasa manufacturing location.
Essential Qualification: M. Sc. (Organic Chemistry / Chemistry) Desired Qualification :
Total Number of years of experience: 15- 20 years and above with atleast 5 years at managing Head level position in USFDA approved API manufacturing site.
Must have a sound knowledge of cGMP requirements form the Engineering perspective.
Preferred Age Group: Between 38 – 45 years
Daily planning of Testing on priority basis and distribution thereof to particular section.
Assign a team or person for handling of market complaints and laboratory phase· of investigation for Out Of Specification (OOS).
To approve and review Standard Operating Procedure (SOP), QC-GMP, QCOPP,· QC-CAL (SOP,s).
To Ensure that the departmental activity are carried out smoothly and effectively· as per cGMP norms.
Co-ordination with other related departments. (i.e Production, Quality· assurances Engineering, Analytical development and R&D)
To check/approve the calibration and preventive maintenance record of· instrument as per SOP.
Final review of all critical data and data which are received from outside parties.·
Approval of indent and capex for suitable equipments and services.·
To co-ordinate with ADL and R·&D for Technology transfer.
Check the compliance of QC SOP/STP.·
Review of all analytical data related to Raw material, Intermediate, stability, Finish API’s and Packaging material.
Release and rejection of Raw material, Intermediate, Finish API’s and· Packaging material.
Internal raw data checking of all log books and calibration records.·
Providing training to junior level related to quality work and proper distribution of· work.
Further planning of more instrument and people as per cGMP norms.·
Responsible for Method validation· & its transfer to respected location/department.
Support to QA· & RA department to respond the regulatory deficiency.
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