Head of Quality Operations (Pharmaceutical)

A Reputed Pharmaceutical Company

 

A Reputed Pharmaceutical Company

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Summary

• Vacancy: 1
• Location: Gazipur
• Salary: Negotiable
• Experience: 12 to 24 years
• Published: 14 Aug 2024

 

Requirements

Education

• Master of Science (MSc) in Pharmacy

• Masters of Science in Pharmacy/Micro Chemistry/Applied Chemistry from a reputed university.

• Certification in Quality Control System will be an added advantage.

Experience

• 12 to 24 years
• The applicants should have experience in the following business area(s):
  Pharmaceutical/Medicine Companies

Responsibilities & Context

• Develop and implement the Quality department’s strategy, to ensure it meets the business requirements and customer deliverables, as well as ensuring the departmental performance against company’s goals.
• Ensure establishment of the site quality policies and is being followed in every phase of manufacturing, testing and distribution of drug products in line with cGMP guidelines.
• Approve the Quality Manual with quality policies, Site Master File, Site Validation Master reports by collecting, analyzing, summarizing information, trends upon review and in line with regulatory guidelines.
• Ensure implementation of all approved documents at site, practices are in place and all activities are performed in accordance with approved documents and compliance of GMP.
• Ensure updating of regulatory/pharmacopeial requirements to comply GMP and to meet validation, Quality Control, Microbiology and other requirements as recommended.
• Ensure product approval and rejection manufactured at the site by reviewing and evaluating the batch manufacturing and packaging records, Quality control data, Environmental data and other quality related documents (such as change control, deviations report etc.) and based on satisfactory results arrange to release batches for sale with certificates.
• Maintain regulatory authorizations, including regulatory submission of variations if any.
• Ensure implementing and monitoring of Quality Management Systems and lead the quality operations team to achieve quality operations vision.
• Achieve quality operational objectives by sharing information and by analysis of strategic plans and reviews; preparing and completing action plans; implementing quality and customer-service standards, identifying problems, completing audits, determining system improvements and implementing changes effectively.
• Guide and supervision of Quality Operation team involved for documentation and QA final review for QA batch release, compliance of Quality Management Systems and other activities such as change control, deviation and non-conformance reports, out of specifications.
• Ensure appropriate investigations of discrepancies, errors, complaints, out of specification, Microbiology data deviation, other failures or adverse events for root cause analysis.
• Ensure that self-inspection & vendor/suppliers audit program is in place as per schedule or as required. Also, leading customer and regulatory audits/inspections as and when required.
• Develop quality operations plans by implementing and maintaining an effective quality risk management system to ensure that risks are properly assessed; adequately controlled in accordance with current GMP requirement; identifying critical control points & preventive measures; establishing critical limits and monitoring procedures.
• Lead the validation team by managing all validation activities are in place, including validation strategy, approving protocol and reports.
• Prepare and justify the quality department’s budget and ensuring that the Quality department meets or improves on budget, cost, volume and efficiently targets (KPIs) in line with business objectives.
• Approve Qualification of Vendor/Supplier and establish Technical/Quality Agreements with the qualified vendors/supplies.

Skills & Expertise

Pharmaceutical Quality Control

pharmaceuticals quality assurance

QUALITY ASSURANCE

Quality Audit

Quality control

Quality Control Management

Quality Control/ Inspect

Quality Management

Workplace

Work at office

Employment Status

Full Time

Job Location

Gazipur

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