Cisen Pharmaceuticals India Private Limited Hiring EXECUTIVE / SR. EXECUTIVE – DOA Apply Now
Job Description:
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.
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