HIKAL Ltd., 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 Title: Quality Control Officer
No of Posts: 01
Salary: As per industry standards
- Responsible for handling the products manufactured in a block.
- Issuance, Review of Batch Production and Control Records, Batch cleaning record, Packing and dispatch record and
- Approval of completed cleaning records. Review of qualification documents (URS, DQ, IQ, OQ and PQ).
- Department rounds to ensure that the quality system is being followed in all departments.
- To give line clearance to the particular equipment / area. Issuance of QC protocol.
- Training coordination, conducting training on departmental SOPs. Data compilation and Preparation of Annual product quality review
- Co-ordination for Review and Closure of Deviations, Change controls, Out of trend and Out of specification and Failure investigation.
- 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.
- Handling of market complaints and recalls (logging, investigation and review).
- To coordinate for the compliance of external / Customer audit reports. Assisting regulatory affairs department by providing required documents for filing/update.
- 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.
- 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.
- 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.
- 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.
- .Responsible to handle any other tasks, other than above, assigned by Head Quality and above.
Qualifications: M. Sc (Chemistry)
How to Apply:
Click here to Apply Online