Cisen Pharmaceuticals India Private Limited Recruitment 2021.Cisen Pharmaceuticals India Private Limited Notification full detailes below.isen Pharmaceuticals India Private Limited, a subsidiary of Cisen Pharmaceutical Co., Ltd. – a research based pharmaceutical company, was incorporated on 20 September, 2018. … The main focus of the Cisen Pharmaceutical India will be development of quality generics pharmaceutical products.
Important Vacancy details:
- Post Name: Executive / Sr. Executive – DOA
- Experienced:5 to 10 years
- Location: Verna
- Salary: NA
- Openings: NA
Note:If interested candidates can share your resume to mentioned mail ID Below.
Job Description: Hiring For Executive / Sr. Executive – DOA in Cisen Pharmaceuticals India Private Limited!If interested candidates can share your resume to mentioned mail ID
- Development Quality assurance / Quality assurance role with experience in Pharmaceutical Research and Development (Formulation and Analytical Dept.) center, Pharma R&D/ Manufacturing unit set-up experience is preferred, Local FDA related compliance activity and related quality Documentation.
- Statutory compliance related activity experience including T-License (from Local FDA), DCGI NOC and Import and Export License application documentation is required.
- Quality system set-up and preparation of related SOP / IQ / OQ / PQ and other documentation and activities required for Pharma R&D.
- Provide on-site support and supervision for Quality system in Pharmaceutical R & D to ensure smooth, efficient operation of the Formulation and Analytical laboratories with maintaining pharmaceutical quality system.
- Knowledge of Preparation of SOPs, guideline and all auditable quality documents.
Responsible and support for Qualifications of equipments and AHU related to formulation R&D plant.
- Review of batch manufacturing, Filing and Packing batch records, specifications, sampling instructions, test methods and another Quality Control procedure.
- Handling of Internal & External audits and its compliance.
- Experience in Vendor audit and qualification of the vendor.
- Experience in Review and Approval of Quality Agreements with customers.
- Experience in handling of investigations to find out the root cause in Out of Specification,Out of Trends, Deviation, Batch failure, Rejections.
- Review and approve the Process, Equipment validation / qualification protocols, reports, product specifications, test method and calibration related documents.
- Knowledge of Regulatory Guidelines such as USA, EU, China etc.
- Expert in QMS documentation, Quality and Validation, Audit as member to facing auditors.system design and implementation.
- Knowledge of Quality control GLPs and Lab Co-ordination.
- Responsible to handle the team to achieve the set targets with maintaining quality as well as cGMP.
- Responsible for coordinating with other departments like stores, Pharma R & D, QC, Maintenance, purchase department, process development lab in day to day activity for better operational requirements and to follow the cGMP requirements.
- Responsible to prepare the weekly and monthly reports and react accordingly to achieve the better targets and to fulfill the quality control requirements.
- Participate in the investigation of complaint, deviation, change control, non-conformance, incidence, vendor audit, external testing laboratories audit; its impact assessments; review its reports and monitor the implementation of CAPA.
- Experience in conducting internal audits and audit preparedness and compliance of audit observations with proper CAPA.
- Knowledge about preparation and review of Development reports, validation reports, SOPs, Qualification documents, Lab note books, Specifications and all other quality documents.
- Preparation, review and issue of finished product specifications. Finished product certificate of analysis (If required).
- Miscellaneous activities including assistance to regulatory team in preparation of product labeling, raw materials (active and inactive) specifications, MOAs and COAs, packing materials specifications etc.
- Should have good experience of regulatory audits like USFDA, EU, MHRA, TGA, ANVISA etc.
- Should have good knowledge of all dependent functions of Formulation R&D, QA & QC; stability, Validation / Qualification, IPQA, Quality management systems, compliance, commercial releases, Vendor audits etc.
- Exposure to third party manufacturing.
- Monitoring of Pharmaceutical R & D’s validation activities, Preventive maintenance program, Calibration program etc.To ensure that all the records are retained as per the requirement.
- Any other responsibilities given by the Head of the Department / Management.
Candidates having experience in USFDA approved Pharmaceutical company, WHO GMP approved pharmaceutical company, Pharmaceutical CRO will be preferred.
Selection Process: The selection will be on the basis of Interview.How to Apply : Click here for full details and Apply Online