Quality Assurance Manager

Manager - Quality Assurance

Company: Hemas Holdings PLC

Job Profile

• Responsible for ensuring preventive mechanism for identifying risk/failure in advance to reduce probability on batch rejection.
• Responsible for ensuring that all plant activities are carried out in compliance with GMP standards, with a strong emphasis on patient satisfaction through effective risk management practices.
• Responsible to collaborate and engage with internal stakeholders to foster a quality-focused culture and prioritize "patient focus" as a key factor in decision-making processes.
• Responsible for quality compliance aspects during each stage of manufacturing operations and supporting activities as per defined procedures to be compliant (In Place & In Use).
• Responsible for the review of GMP failures and any other failures in the process or Quality systems on site to ensure the appropriate investigation is triggered as soon as practical to ensure that a process is in place for investigating Quality related issues with appropriate Quality oversight.
• Responsible for the timely review of batch documents, completion of relevant deviations and changes to control and ensure correct decision being taken on batch release / reject without an undue delay.
• Ensure presence of Operational Quality during all times of manufacturing including when RCAs are done for Deviation Handling Process in manufacturing & to ensure a robust and effective IPQA system where products can be readily identified and give solutions immediately.
• Responsible for timely completion of Periodic Product Review of products and ensure actions are in place to close any gaps found & responsible for timely implementation of QMS, ensure SOPs are in place and in use as per cGMP guidelines, regulatory recommendations and conduct internal trainings/awareness sessions.
• Responsible to ensure all Quality related documents at site are approved by QA and be the owner of the document management system including document retention and timely retrieval when required.
• Coordinate with internal and external customers in order to ensure effective governance of the QMS.
• Ensure validation program is carried out effectively and all necessary validations are conducted as per pre-approved validation matrix & is responsible for governing the QMS, ensure SOPs are in place and in use as per cGMP guidelines, regulatory recommendations and take appropriate action to meet guidelines target.

Applicant Profile

• Candidate should possess a BSc. or MSc degree in Chemistry / Biology / B. Pharma along with a diploma/ certificate level qualification on quality management from a recognized University or Institute.
• A good understanding of good governance, NVRA and other regulatory guidelines will be an added advantage.
• Minimum 5 years of overall work experience in pharmaceutical / food industry, handling QA function.
• Strong analytical, training, internal auditing and people management skills to work along with multiple stakeholders across the business with strong learning ability.
• Proficient in MS office packages and a good team player with a positive attitude.

Application Procedure

If you believe you've got the drive to take our organization to the next level, apply with confidence. Email your CV to careers@morison.lk with the subject carrying the role you are applying for within 07 days of this advertisement.

An attractive remuneration package on par with the industry standards is on offer for the right candidate.