Role & responsibilities
You will be working as Manager QA for EU & ROW, approved Formulation manufacturing company based at Boisar, Mumbai
Will be responsible for:
1. He/ She will manager QA QMS function for site in Boisar
2. He/ She will be responsible for handling QMS elements like Deviation, Change Control, CAPA,Risk Management.
3. He/She will be responsible for handling, developing, implementing, and maintaining a comprehensive quality management system compliant with regulatory standards.
4. You will be responsible for ensuring that all pharmaceutical manufacturing equipment and facilities are appropriately qualified and validated.
5. You will be responsible for reviewing and approving QMS related SOPs for manufacturing, quality control, and other relevant departments.
6. You will be handling all Regulatory Audits start to end, including, EU GMP,UK MRA, and ROW etc.
Preferred candidate profile
1. Candidate should have a Bachelor's in Pharmacy or Master's of Pharmacy degree in a relevant field (e.g., pharmaceutical sciences).
2. Candidate should have 8-12 years of Experience in Formulation industry with UK MHRA , EU,ROW Approved Company in Quality assurance department.
3. Candidate should have expertise in QMS related activities in Pharmaceutical industry.
4. Candidate should have knowledge of pharmaceutical regulations, particularly GMP requirements.
5. Candidate should be good in handling QMS System & Documentation of OOS/OOT investigations.
6. Candidate should be good in handling Conduct internal audits and inspections to identify and address compliance issues.
Perks and benefits
Keyskills: QMS Capa Change Control Quality Assurance Deviation Risk Management