Cisen Pharmaceuticals

 

Cisen Pharmaceuticals Recruitment for Executive Sr Executive DOA

Important Vacancy details:

1. Post Name: Executive / Sr. Executive – DOA
2. Experienced:5 to 10 years
3. Location: Verna
4. Salary: NA
5. Openings: NA

Note:If interested candidates can share your resume to mentioned mail ID Below.

hr@cisenindia.com

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

hr@cisenindia.com

• 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