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  • 16 - 19 Years
  • Posted : above 1 month

Job Description:

Manager QA

Industry Pharmaceuticals

Location Vishakhapatnam

Open

Functional Quality/ Quality Assurance / QMS / Quality Control / Microbiology



About Us

Spectrum Talent Management is a comprehensive HR services company offering solutions spanning the entire talent life cycle including Recruitment, Onboarding, Payroll and Flexible Staffing Founded in 2008, we are a continuously growing, yet mature service firm specializing in recruitment and staffing requirements of global organizations Our leadership and high acceptance in the market is evident by the phenomenal growth that we have demonstrated in just few years of our inception From Permanent recruitment to Flexi staffing, Payroll management to RPO, the orbit of the value add that we provide our customers with has always evolved, and diversified from time to time This has enabled us to become a preferred vendor with most of our clients

About Company

This is for one of the leading client into pharma company

Roles and Responsibility

Manager Quality Assurance

Industry Pharmaceutical (API) from reputed organisations

Functional Area Quality Assurance

Role Quality Assurance Manager

Team Size 15

Employment Type Full Time, Permanent role

Experience required 12 Years to 16 Years

* This position is based at Visakhapatnam location, Andhra Pradesh I

Required Candidate profile

Responsible for Preparation / review of Validation Master Plan (VMP) Manual & Schedule

Responsible for Preparation / review of Site Master File (SMF) & Quality Management System (QMS)

Responsible for Review of Master BPR & Process Flow Chart

Responsible for Review of Technology Transfer Documents

Responsible for Handling of QAMS Activities Ie Change Control, Deviation and CAPA etc

Responsible for impart training sessions like Periodic, General, GMP as per schedule/ applicable

Responsible for Product Release activities & ensuring its documentation as per the regulatory standards

Responsible for Handling of OOS and OOT

Responsible for Reviewing of Specification & Method of analysis

Coordinate to conduct and preparation of Quality Review Meeting (QRM), Management Meeting (MRM)

Handling of Internal audits compliance

To ensure that completed batch production and laboratory control records are reviewed & approved before release of the API for distribution / release

To Handle market complaints, return goods

Handling of vendor management activities

To verify the calibration status of all instruments of Quality Control, Production, Utility, Warehouse and engineering

Lead QA team during the customer/regulatory audits and its compliance

To support & coordination during the preparation, review & approval of the DMF filings of RA function, as per the current regulatory guidelines

To monitor the cGMP Compliance in all functions

Ensure the sample submission to customer as per the requirement, to handle Quality Risk Management, Other functional requirements and Laboratory systems & Compliance

* Preferred Candidates who has done DMF, CEP filings and Audit preparation of EQDM, USFDA, TGA, JPA etc regulatory bodies, strong knowledge on QA from API background, Ensuring the complete quality management system ie Change control, Deviations, Incidents, Out of specifications, CAPA and system effective implementation

Desirable experience

Relevant product & scientific knowledge

Understanding of Key Pharma market dynamics and changes

knowledge of Pharmacopeia and regulatory guidelines

Business acumen and Business forecasting

Strong knowledge on Regulatory/Process norms

Strong analytical and problem solving abilities

Relationship management with various stake holders

Collaborative work - ability to drive Cross Functional Teams particularly in an environment where stakeholders may not necessarily have fully aligned / aware with typical Quality norms and driving them collectively in a uniform way towards and creating Quality Culture across teams and accomplishing results

Skills Required

Functional Skills

Knowledge on regulatory norms and best quality practices of API Pharmaceutical, QAMS, SAP and preparation, review and monitoring mechanism of Quality compliance as per the regulatory norms & guidelines Regulatory audit exposure as a front line

Behavioral Skills

Strong Communication skills (written & verbal), Inter/Intra (team) personal relationship management

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Recruitment/Placement Agencies, Consulting Services
Functional Area : Quality/Process Control
Role : Quality Assurance
Salary : As per Industry Standards
Deadline : 14th Apr 2020

Key Skills:

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