11/03/2016
QA (Validation)
In this role, you will work with all functions to create, revise, execute qualification and validation protocols and reports. This includes process, facilities, utilities, equipment and cleaning validations in accordance with Company VMP and procedures.
Here’s a summary of this opportunity:
Responsibilities: Creates and maintains site validation and equipment qualification programs; routinely involved with generation, review of IQ, OQ, PQ protocols and reports; Perform, evaluate and analyze validation protocols and associated data for compliance with good validation practice guidelines; Prepare and maintain site Validation Master Plan for the site (in conjunction with Engineering, Manufacturing, IT, Service and QA); Assist in the investigation and development of CAPA following any protocol ex*****on non-compliance and any validation study failures, in line with site procedures; Participates in internal and cross-site audit programs when needed; Ensuring policies, procedures and practices are in compliance with global quality & regulatory requirements and meet the needs of our customers & Corporate Quality Policy and Site Quality Manual; Responsible for performing tasks to support the quality system and quality policy as directed by QA management and Site Leadership; Able to perform risk assessments and impact analysis on current validated processes; Actively participates in site-wide continuous improvement activities; Drafting new, and revising existing Standard Operating Procedures (SOP).
Qualifications:
Prefer BS/BA Degree in Quality Engineering or a related a scientific/technical field (Biology/Chemistry); 3-5 years related work experience, working in a regulated environment within pharma, medical device or biologics; Must be proficient on validation and qualification protocol development, data analysis and report writing; Working knowledge of design control; Working knowledge of cGMPs, cGVPs; Experience conducting independent investigations – includes identification of CAPA; Demonstrated ability to work effectively and positively with all levels of an organization; Capable of working both independently and in a team setting; Team oriented and committed to continuous improvement; Proficient skills with Microsoft Office (Word, Excel, PowerPoint); Strong organization skills required.
If you are interested in one of these challenging positions send your detailed CV along with presentation letter to:
CHEMI PHARMA Ltd., HHF014 Hal Far Industrial Estate, Hal Far BBG3000, Malta
Or by email to: [email protected]