We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Senior Specialist/ Assistant Manager, Quality Assurance
- Contribute in setting up & maintaining QMS (including GCP & GVP Compliant process) for managing pharmacovigilance, Clinical trials, Medical/Scientific writing (Clinical & Non Clinical) & regulatory process (NDA, ANDA Submissions) quality assurance in accordance with the internal procedures established at PharmaLex India.
- Develop internal audit plan/agenda as per inhouse SOP and conduct internal audits based on current national & international GCP & GVP regulations & act as cross functional reviewer (wherever applicable)
- Perform comprehensive vendor evaluation and due diligence in order to mitigate company’s risk involved in outsourcing of services
- Contribute in management of Electronic QMS system at PharmaLex India
- Ensure all KPIs for QMS are met at Pharmalex India
- Review & Trend analysis of deviations / Non-Conformance, CAPA, Change Control & their conducted investigations/root cause analysis
- Coordinate periodic management review meetings
- Ensure compliance to internal training and documentation procedures
- Preparation and revision of QA procedural documents
- Supporting Client and CQA audits and provide response/CAPA to audit observations as per internal procedure.
- Review of internal processes, especially those that affect the quality of the organization’s products
- Report to QA Head on the performance of the QMS (e.g., results of quality audits, corrective actions, deviations & complaints), including the need for improvement
- Any other responsibility assigned by Management
Your ProfileGraduate/Post-graduate/Doctorate degree in life sciences/Pharmacy/Medical sciences or equivalent degrees
. 3-5 years of relevant experience in Quality Assurance or related industry experience
. Knowledge of current GCP & GVP regulations, quality standards & industry best practices.
. Good knowledge and understanding of the pharmaceutical industry and understanding of ICH E6, ICH E3, ISO 9001, ISO 27001 & GDPR regulations
. Good analytical skills, Strong written and verbal communication skills, Good computer skills (excel, PowerPoint & word), Solution oriented, ability to plan, organize and prioritize activities.
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us:
Ms. Vineeta Bisht
Manager, Human Resources India