KASHIV PHARMA LLC.

Job Description

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Job Title / Director, Quality Management
Business Unit / Quality Management
Department Name / QA
Function / QA
Supervisor / COO & EVP R&D
Job Status / EXEMPT
Date / May 1, 2017

Position Summary

The Quality Management, Director is responsible for maintenance of Kashiv Pharma’s quality management system, supervise QA Associates, documentation/ SOPs, change controls, deviations/ investigations, master code book, raw material & finished product final QA release (COA- Certificate of Analysis issuance), batch record review, quality assurance (QA) duties, regulatory compliance (RC), stability program, facility / equipment qualifications, equipment cleaning verifications/ validation, training and ensuring that operations are conducted in accordance with current Good Manufacturing Practice.

Essential Duties & Responsibilities

Key responsibilities of the position include, but are not limited to –

·  Actively assist all departments in the generation of quality system documentation such as SOPs, deviation reports and change control.

·  Review and approve master batch records (manufacturing and packaging), executed manufacturing & packaging batch records and associated supporting documentation/ memos.

·  Carry out internal and external company audits to ensure GMP compliance.

·  Review CMC related documents for ANDA/ IND/ NDA filings for Regulatory Compliance and Accuracy.

·  Identify, create, review, approve and implement SOP revision requirements.

·  Assist in the preparation, if applicable and review of post filing documents for ANDA/ NDA including FDA comments and responses.

·  Coordinate the conduction of investigations and corrections for issues found during the batch record (manufacturing and packaging) review process and analytical tests out of specifications (OOS) data for both internal and external projects.

·  Compile and report on quality system metrics to identify trends and facilitate management review.

·  Conduct regular QM meetings along with ARD, Technical Services, Engineering, QA Associates, Documentation Control Team, RC Auditor and Technical Writer.

·  Notify the Management Team of any issue that may impact the client/ partner company product (quality issues, batch record, COA completion deadlines); Resolve and provide solutions by collecting information from related department(s) and complying with CFR & FDA Guidelines.

·  Notify the COO of any issue that are, or may become, a GMP compliance issue.

·  Interface with all levels of Kashiv Personnel, Partner Company, Third Party QM in resolving issues.

·  Perform other duties required of the QM and QA team as and when required.

Position Requirements and Qualifications

·  Master’s Degree (required) in Chemistry, Analytical or Pharmaceutical Sciences from US University.

·  Minimum of 10 to 15 years relevant experience in a pharmaceutical quality assurance/ control / regulatory compliance environment; Prefer to have working and technical knowledge of key pharmaceutical R&D, manufacturing and packaging processes in drug delivery area.

·  Experience of GMP document review, Quality Management System maintenance, quality auditing.

·  Understand the requirements and procedures related to document control, Quality Assurance, ARD/ QC and FDA regulations/ current published guidances.

·  Ability to work with teams and independently - good interpersonal skills.

·  Good communication skills: verbal and written, good computer and organization skills, detail oriented.

·  Problem analysis and solution skills.

·  Prefer to have knowledge and experience in Electronic Enterprise Resource Planning (ERP) System/ QM Systems for Inventory Control, Change Controls, Deviations, SOPs and Report Writing.

·  Mathematical/Language Skills: Good mathematical skills required.

·  Computer and/or Technical Skills: Good computer skills, including in depth knowledge of Word and spread sheet software required.

Work Environment & Physical Demands

General Work Environment: Normal

Standing/Lifting: Normal

Visual: Normal

Stress: Ability to work under pressure and meet deadlines

Travel: Up to 10% may be required


Supervisory Responsibility

·  Supervise a staff of Quality Assurance Associates/ Personnel, Compliance Auditor, Document Specialist, etc.