Website Syngene International Ltd
Post Name: Equipment Qualification/Validation Team member
Location: Mangalore
Designation: Senior Executive
Department: Corporate Quality Assurance
Job Description:
Key Responsibilities:
Preparation and review of equipment, utility qualification relevant procedure and ensuring execution compliance as per approved SOP.
Responsible for preparation of protocols and reports inline to site specific SOP for chemical development facility.
Review of procedures, URS, impact assessment, Risk assessment, protocols & reports for qualification & validations for facility/Area, equipment & utilities in facilities.
Coordinate the activities of qualification/validation with the stakeholder departments, ensuring the timely completion of projects and project milestones.
Ensure QA validation oversight during FAT, commissioning /SAT and IQ, OQ & PQ as per qualification requirements & documentation.
Review of Design documents and execution of IQ, OQ and PQ activity of the new facility/product/process critical equipment along with documentation in place in time as per defined procedure.
Review of facility, Utility related drawings/layouts (for ex., pressure differential, AHU zoning, area classification, equipment layouts, piping drawings, isometric drawings etc.).
Ensure QA validation oversight during periodic validation of critical process equipment, utilities such as HVAC systems water system and compressed air systems revalidations.
Supporting to prepare VMP Calendar. Ensuring execution of Re-qualification activities as per VMP calendar tolerance.
Support external client audits and regulatory inspections.
Educational Qualification: M.Sc. / M. Pharm/ B. Pharm/ /B. Tech
Technical/functional Skills:
Technical knowledge in chemical API is must.
Technical knowledge in Biologics and Injectable are add on value.
Should have minimum 3 years of work experience in Pharmaceutical Validation systems (Facilities, Utilities, Equipment, and Computerized Systems).
Manufacturing Computerized System Validation (CSV)/ Process Control System deliverable preparation/review.
QMS procedures.
Should be knowledgeable on validation guidelines per different regulatory requirements and Industrial bodies, e.g., ICHQ2, ICH Q7, WHO, US FDA, EU guidelines, 21 CFR, ISPE, PDA, and PICS.
Interpersonal skills to establish collaboration with cross-functional teams
Establish good Interpersonal skills with cross-functional teams.
Experience: 3 to 6 Years + experience in the pharmaceutical Chemical API industry.
Behavioural Skills:
Should have good communication skill and should be a good team player.
Ability to work successfully in a dynamic, ambiguous environment.
Ability to meet tight deadlines and prioritize workloads.
Competences:
• Excellent written and verbal communication skills
• Good interpersonal skills
• Analytical strengths and high trouble shooting ability
Equal Opportunity Employer:
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.
