QC Manager

PharmaSwiss, part of Bausch Health Companies, is one of the leading pharmaceutical companies in Serbia, that has been marketing its own and third-party products for many years now, while nurturing strong customer-oriented and consumer-centric approach in its everyday business. As a result, we are very proud of our strong reputation among healthcare professionals and consumers. Our goal is to make this leading position even stronger for years to come.

We are looking for dynamic and responsible candidates for the open vacancy in our Quality team: 

Quality Control Manager

Key Responsibilities:

• Organizes and manages the activities of the Quality Control department
• Approves testing results of starting materials, finished products and stability testing results
• Organizes and controls activities related to sampling of starting and packaging materials, semi-finished, finished products and ambient monitoring in production
• Approves starting materials, packaging materials and in-bulk products for use in production and prepares certificates of analysis for the finished product (CoA)
• Manages Quality Control documentation and quality records using the eDMS platform
• Maintain Technical (GMP) contracts with approved QC services providers and supervises their work
• Ensures maintenance of the QC equipment and all qualifications/calibrations are done according to the plan
• Participates in creation of URS for new equipment
• Ensures that ambient conditions meet the specification requirements
• Ensures that necessary validations/transfers of analytical methods have been performed
• Ensures that QC staff have all the necessary trainings performed on timely manner
• Ensures that QC staff works in line with EHS requirements
• Reviews/approves Stability study reports of batches from routine production
• Controls level of supplies/ purchase of reagents, reference standards and other materials for QC purpose 
• Participates in external audits by regulatory authorities, certification bodies and licensing partners as well as corporate/global inspections
• Participates internal audits
• Ensures that all specifications of packaging materials, in bulk, semi-finished and finished products are in accordance with Marketing Authorization
• Performs periodic review of finished product test results and OOS results/trending
• Reviews and approves equipment qualification protocols
• Participates in the investigation of non-compliance and the implementation of corrective/preventive measures
• Participates in the investigation of market complaints and writing relevant reports
• Proposes measures to improve the quality management system (Enterprise excellence)
• Directly reports to Plant Director
• Reference: b7-nzYiYzW6p4t-z4POXXdZE_Bx4TH3SHF5RZoNtbWkJouyxbnRT0dVj8I1FbdaB

Requirements:

• University degree, Master of Pharmacy
• Finished specialization in Drug testing and Quality Control
• Minimum 5 years of relevant work experience in in analytical laboratory in pharmaceutical industry and 3 years as QC Manager
• Sound knowledge of National and EU GMP regulations, legal regulations for pharmaceutical industry
• Fluency in English

Candidates profile:

• Good interpersonal and presentation skills
• People management skills
• Ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way
• Analytical skills and good judgment