Cisen Pharmaceuticals India Private Limited Hiring 2022 .Cisen Pharmaceuticals India Private Limited Notification full details below.Interested and eligible candidates Submit Resume.Cisen Pharmaceuticals India Private Limited, a subsidiary of Cisen Pharmaceutical Co., Ltd. – a research based pharmaceutical company, was incorporated on 20 September, 2018. The registered office of the company and Pharmaceutical Research and Development Centre is at Plot No. S-86, Phase II-C, Verna Industrial Estate, Verna, Goa.
- Post Name: Executive/ Sr. Executive-DOA
- Qualification: Graduate
- Experienced:5 – 10 Years
- Salary: NA
Job Description: Cisen Pharmaceuticals India Private Limited Hiring For Executive/ Sr. Executive-DOA !
Important Details :
- Post of date:11/08/2022
- Location: Verna
- Selection Process: The selection will be on the basis of Interview.
- Interested candidates should email their current resume with photograph and current and expected salary / CTC to following email id firstname.lastname@example.org
Roles and Responsibilities
- 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.
Interested candidates should email their current resume with photograph and current and expected salary / CTC to following email id
Please mention DQA in the email subject.
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.