Company Name: HIKAL
Ltd
About Company: Established
in 1988, Hikal is a reliable partner to companies in the Pharmaceuticals,
Biotech, Agrochemicals and Specialty Chemicals industries. We provide
world-class Active Ingredients, Intermediates and R&D services and
solutions in a safe, secure and confidential manner. Our advanced
infrastructure has been inspected and approved by globally recognized bodies
such as the USFDA.
Hikal is a company
built on enduring relationships. We are committed to delivering value as a
complementary partner. By delivering on this commitment, we have earned the
respect and recognition of leading companies from around the world.
Job Type: Walk-in
Departments:
Quality Control
Designation: Quality
Control Officer
Job Responsibility & Profile:
1 Responsible for
handling the products manufactured in a block.
Review and archival
of MFC and batch records.
2.Issuance, Review
of Batch Production and Control Records, Batch cleaning record, Packing and
dispatch record and 3.Approval of completed cleaning records.Review of
qualification documents (URS, DQ, IQ, OQ and PQ).
4.Department rounds
to ensure that the quality system is being followed in all departments.
5.To give line
clearance to the particular equipment / area. Issuance of QC protocol.
6.Training
coordination, conducting training on departmental SOPs. Data compilation and
Preparation of Annual product quality review
7.Co-ordination for
Review and Closure of Deviations, Change controls, Out of trend and Out of
specification and Failure investigation.
8.Preparation of
validation protocol and reports (Process and cleaning validations),Release or
rejection of Intermediates, Recovered solvents from SRU. Initiation of hold
time study, Homogeneity study and follow up for closure.
9.Handling of
market complaints and recalls (logging, investigation and review).
10.To coordinate
for the compliance of external / Customer audit reports.Assisting regulatory
affairs department by providing required documents for filing/update.
11.Handling of
Shift activity.Co-ordination for ISO internal quality and customer
audits.Issuance and follow up for updation of specifications & SOPs.Batch
allotment for dispatch activity.
12.Attending
customer questionnaires.Dispatch clearance, preparation of COAs and label
control.Follow up with support functions for closure of documents.Preparation,
review and issuance of standard operating procedures.
13.Co-ordination to
obtain manufacturing licenses and GMP certificates.To follow the safe practices
mentioned in various SOPs for operations.To participate in EHS training and
adherence to EHS systems.
14.Review of
calibration & Stability data.To give EHS related suggestions for
improvement of EHS system.Preparation of Audit compliance and follow up for
CAPA closure.
15.Responsible to
handle any other tasks, other than above, assigned by Head Quality and above.
Qualification Required:
M.Sc(Science) - Chemistry
Experience Required:
2 - 5 yrs
Interview Date: 18th
November
Time of Interview: 10
AM onwards
Interview Location:
Hikal Limited, 82/A, KIADB Indl.
Area,&Jigani,Anekal Taluk, Bangalore - 560105
Remark note:
1. Experience in Quality Assurance in API / Bulk
Drug Manufacturing industry.
2. Good communication skills
3. Exposure to customer and regulatory audits
like USFDA.
4. Candidates who are willing to work in all
shifts and ready to relocate to Bangalore should only apply.
5. Qualification Must be M.Sc.
Thanks for visit again….. We create HOPE….
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