REGULATORY AFFAIRS/ QUALITY ASSURANCE MAHARASHTRA/BANGALORE/HYDERABD/CHENNAI Job For 0-2 Year Exp In Mumbai, Mumbai City, Navi Mumbai, Thane – 3762127


REGULATORY AFFAIRS/ QUALITY ASSURANCE
MAHARASHTRA/BANGALORE/HYDERABD/CHENNAI
QUALIFICATION: MSC/BPHARM/MPHARM
EXPERIENCE: FRESH OR ONE YEAR

Key job responsibility area

reliable Executive of Quality Assurance to ensure that all external and internal
requirements are met before our product reaches our customers. You will be responsible for inspecting procedures and
outputs and identifying mistakes or non-conformity issues.
Responsibilities:

• Devise procedures to inspect and report quality issues
• Monitor all operations that affect quality
• Supervise and guide inspectors, technicians and other staff
• Assure the reliability and consistency of production by checking processes and final output
• Appraise customers’ requirements and make sure they are satisfied
• Report all malfunctions to production executives to ensure immediate action
• Facilitate proactive solutions by collecting and analyzing quality data
• Review current standards and policies
• Keep records of quality reports, statistical reviews, relevant documentation and perform
statistical analysis
• Communicate with external quality assurance officers during on-site inspections
• Devise and review specifications for products or processes
• Ensure adherence to health and safety guidelines as well as legal obligations
• Oversee all product development procedures to identify deviations from quality standards
• Inspect final output and compare properties to requirements
• Approve the right products or reject defectives
• Keep accurate documentation and Solicit feedback from customers to assess whether their
requirements are met
• Submit detailed reports to appropriate executives
• Be on the lookout for opportunities for improvement and develop new efficient
procedures
• WHO GMP requirement, complied all the non conconformities. Carried out all for ISO &
WHO GMP, Handle Safety audit.
KEY REPONSIBILITES
• Review & Preparations of Quality Management system documents.
• Review, preparation & Implementation of SOPs
QUALIFICATION & VALIDATION

• Preparations & execution of qualification and validation of various manufacturing &
packing equipments.

PROCESS VALIDATION

• Preparations & Execution of process validation activity.
GMP DOCUMENTS COMPLIANCE
• Preparations of Master Formula Record /Batch manufacturing record/Batch Packing
Record as coordination with Production, R&D, and Client.
• Execution of necessary documents for finished goods release.
• Issue & control of the Batch Manufacturing & Batch Packing Records
• Issue & control of Raw Material Specifications & Packing Material Specifications.
• Preparations and compilaton of Annual Product Review/Product Quality Review
• Review and compliance of Master Batch Manufacturing and Master Batch Packing
Record for various regulatory requirements.
• Periodic review, issue & control of SOP.
• Daily Temperature & RH monitoring, Periodic observation & destruction

Email cv inchcaperocksat the rate gmail.com

Contact 9892553296



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