Officer / Executive Quality Assurance
Job description:
·
Preparing and reviewing Site Master
File, Validation master plan, Master Batch Records.
·
Preparing and reviewing cleaning
validation, process validation and Hold time study protocols and reports.
·
Reviewing of Batch Manufacturing
Records, Batch Packing Records and Bill of material
·
Ensuring adherence to quality standards
& maintaining all the related documents; conducting inspections at various
stages to ensure safety & quality specifications are met without any
slippages.
·
Steering the implementation of cGMP for
all operational activities.
·
Conducting audits and ensuring
compliance and audit readiness; reviewing production documents.
·
Participating in Internal Audits to
ensure quality in other departments like Production, Stores, Engineering etc.
·
Addressing market complaints, deviation,
CAPA, and change management systems.
·
Preparing and reviewing of Annual
product Quality Review.
·
Imparting training, conducting online on
job as well as classroom trainings for cGMP, cGDP to support subordinates
·
Preparing and reviewing SOPs related to
Quality Assurance, Production, Stores and Engineering
Required Candidate profile:
Minimum 4 to 6 years
of hands on experience in Quality Assurance and handling QMS system and Risk
analysis
Executive QA / Sr. Executive QA
Job description:
1.
Establishing and ensuring the compliance
of all systems as per GMP.
2.
Handling of Customer complaints.
3.
Conducting self-inspection and internal
audit.
4.
Facing Customer and Regulatory agencies
audits
5.
Ensuring proper responses to the
customer or regulatory agencies including making report for audit compliance.
6.
Taking plant rounds daily to ensure the
compliance as per GMP.
7.
Sound knowledge of evaluation of Risk
analysis as per ICH Q 9 and implementation of CAPA.
8.
Sound knowledge of elemental impurities
analysis as per ICH Q 3D and USP
9.
Performing risk analysis as part of
Corrective and Preventive action for OOS / Change control and Deviations
10.Sound knowledge of Implementation Change
control Deviation, OOS and generating risk analysis wherever required and
closure of the same.
Required Candidate profile:
Minimum 7 to 9
years of hands on experience in Quality Assurance and handling QMS system and
Risk analysis, Audit and Compliance.
Experience having
worked in API plant with regulatory approval from USFDA, MHRA,
EDQM.
Shall have good
knowledge and requirement QMS, and ICH Q 9.
Skills / Knowledge/Abilities:
·
Strong technical background and
knowledge of Quality management Systems.
·
Good oral and written communication
skills.
·
Good knowledge of Microsoft office
programs.
·
Ability to adapt and learn to ensure
good decision making in fast pace environment.
Location: Navi Mumbai
Resume shall include following details:
·
Current CTC
·
Expected CTC
·
Notice Period.
Interested
Candidates can send CV to hr@hemmopharma.com
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