Quality Assurance ( Regulatory Affairs)

Key Skills

Quality Assurance Regulatory Affairs Process Execution

Job Description

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.

Experience : 3 - 4 Years

No. of Openings : 2

Education : B.Pharma, M.Pharma

Role : Quality Assurance

Industry Type : Hospitals / Medical / Healthcare Equipments

Gender : [ Male / Female ]

Job Country : India

About a.r. personnel consultant

Job Description:
contracts Handling, Advisory & Legal Updates
drafting, Reviewing and Negotiating Wide Range of Legal Contracts with Partners, Trade-vendors, Customers Etc.
review and Share Comments On Share Holder Agreements, Loan Agreements, Joint Venture Agreements, Technical Collaborations Etc.
draft Mous, Ndas and Real Estate/ Property Related Agreements and Documentations.
independently Negotiate Contracts and Advise the Company On Interpretation of Contractual Clauses.
Assess and Advise On Legal and Contractual Terms of Contracts.
Protection of the Companys Interest.

research, Diligence & Legal / Statutory Compliances

conduct Legal Due-diligence of Group Companies;
search & Verify Property Title, Assist in Issuance of Title Clearances Certificate, Perusing and Verifying 7/12 Extracts, Mutation Entries, Register of Holdings, Property Cards, D.p Remarks, Zone Certificates & other Necessary Revenue Records;
preparing other Miscellaneous Documents Relating to Property Transactions;
conduct Research and Oversee Various Laws, Rules, Regulations Regarding the Companys Acts and Various Statutory/regulatory Compliances Related to Contract Labour Act, Companys Act, Shops & Establishment Act & other Relevant Acts;
Prepare Checklists for Compliances Under Relevant Laws, Coordinating with Various Departments and Ensuring the Compliance as per Checklist, Preparation of Monthly/half Yrly/ Annual Compliance Report, Preparing Action Plan for Noncompliances, & other Legal Requisites;
review & Recommend the Management On Company Policies, Procedures Relevant to Human Resource Management;


review Cases & Preparing Briefs
prepare Briefs On Legal Matters for Management and Companys Advisory Councils and Coordinate Meetings On Behalf of Management with Attorneys and Council.
Review Progress of Ongoing Cases and Provide Regu
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