Deputy General Manager - CQA

Shalina Healthcare

Navi Mumbai, Mumbai, India

20-22 Years

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Posted 23 hours ago
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Job Description

About Shalina Healthcare:

Shalina Healthcare is one of the largest pharmaceutical companies in sub-Saharan Africa. For the last 40 years we have made it our mission to provide quality medicines to those who need it the most. We manufacture and distribute branded prescription and over-the-counter pharmaceutical and consumer products, across a broad range of therapeutic groups, including anti-malarial, antibiotics, anti-inflammatory and nutrition. We have a track record few can match and our brands are among the most trusted in Africa.

We are proud of our history and have big ambitions for the future. Our vision for 2030 is to be the health champion of Sub-Saharan Africa. To achieve this, we are looking for the right people to join us and create a lasting impact not just within our company but on the communities we serve.

Everyone in our company has a crucial role to play, and we are looking for people who identify with our Core Values and are as passionate about our Mission as we are.

The Global Supply Organization is a multi-continental Function that comprises of the entire Value Chain from product conceptualization to delivery to the commercial front. Within the Global Supply Organization are included, Research & Development, Project Management, Manufacturing, Quality, Supply Chain Management and Logistics.

Role: Deputy General Manager – External Quality

Designation Deputy General Manager

Base location: Pawane, Navi Mumbai

Reporting To: Vice President - Quality

What you become a part of:

Senior Manager Quality To lead the team of quality professionals in CQA to review and approve documents, investigations, market complaints, CAPA, gap assessments, vendor management, technical trainings and support Inhouse sites for compliance etc. Ensure/comply with Shalina QMS systems in compliance with internal and regulatory requirements

What to expect:

To review, evaluation and approval of new third party launches and transfer of existing products from one site to another.
To ensure improvement, work simplification, continuous review and up gradation of existing External Quality SOPs
To ensure that any non-conformance or quality concern is properly investigated and documented and to ensure implementation of corrective actions and preventive actions
Review, evaluation, impact assessment and approval of SOP's, Master documents and QMS investigations in DMS and QMS.
Review of due diligence audit outcome and compliance. Approval, rejection and conditional approval of the manufacturing/testing facility based on compliance.
Ensure timely preparation and adherence to APQR planner, Stability Planner and Process validation planner to monitor overall performance.
Facilitate/support CMO sites for regulatory audits and ensure all time audit readiness through periodic quality oversight visits and pre-assessment before regulatory inspection.
To ensure on time technology transfers of products/analytical methods from R&D to
CMO site & location to location transfers.
To ensure Quality index parameters for LLU sites and present to management through quality review meeting.
To support internal and cross functional teams to achieve the objectives on time
To ensure FG releases are within the defined lead time at LLU sites and to monitor FG inspection effectiveness and batch release activity.
To implement action ables agreed under new TP framework for to enhance quality culture across external manufacturing organization.
To ensure witness manufacturing, witness analysis and quality agreements are executed from all CMO sites.
To ensure planning, execution, review and approval of process validation, APQR &
Hold time activity at respective CMO's as per production plan.
To ensure on time stability sample withdrawals and monitoring stability results. To provide support for investigation and closure Stability OOS, if any.
To provide technical inputs/guidance to CMO's for compliance and ensure implementation of Quality systems at CMO's and effectiveness monitoring.
Co-ordination and undertaking of overall functional activities in absence of team lead from respective sub-sections.
To perform SAP related activities as per the requirement of respective SOP's, batch release & departmental needs.
Preparation for presentation of Monthly Quality review meeting (QRM) / business meetings to present overall status of the section and to highlight any open issues which was not resolved within timeline.
To Identify potential successors and develop team members to prepare them for new roles within or outside of their core function.
Overall quality compliance assurance with internal and external stakeholders/vendors.

Qualifications, Experience & Skills

Preferred Candidate:

20+ years of experience in pharmaceutical quality management.
Significant experience in leading external quality operations, regulatory inspections, technology transfers, and vendor quality management.

Qualification:

Bachelor's/Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or related Life Sciences discipline.
Additional certifications in Quality Management, GMP, or Six Sigma, will be preferred.

Technical Competencies