Greetings from Zydus Pharmaceuticals!!!!
We are looking for QMS Lead for our OSD Manufacturing Facility based out of Ahmedabad
- Education Qualification: M.Pharmacy/ B. Pharmacy
- Experience : 12-15 Years of experience in QMS .
- Salary: ₹ 12-18 Lacs P.A.
Roles and Responsibilities:
The candidate should be handling of Process investigation, Market complaint, Adverse drug events, incidents, CAPA & Change Controls in Trackwise system viz. Logging, Investigation , closure and effectiveness check with coordination of cross functional team and subject matter experts.
Trending of various QMS tools like Market complaints, incidents and CAPA to assess any emerging trend and escalate to site management to recommended CAPA wherever applicable.
Review of batch records and supporting document with respect to final batch release to market sale and prepare certificates of compliance.
Performing Quality risk assessment triggered from various QMS tools and ensure the implementation and effectiveness of identified mitigation actions.
Prepare Quality Matrix presentation by compiling various QMS data as per regulatory requirement and escalate to higher management team on monthly basis as a Site Quality council lead role.
Perform Gap assessment for site QMS procedures to make in line with global policy to ensure enhancement of compliance as per updates on regulatory guidance.
Handling of raw and packaging material vendor management activity like Qualification, periodic Qualification, onsite audits, supplier impact assessment and annual evaluation etc.
Preparation of Quality technical agreements related to raw and packaging material vendors, service providers, customers and other Mylan entities.
Participate in Cleaning validation activity viz. preparation and execution of validation protocols, equipment grouping, worst case molecule/product/equipment identification, CV metrix, CEHT/DEHT and annual evaluation.
Review and approval of various packaging materials artworks by coordination with packaging development, sourcing and regulatory departments.
Prepare audit compliance report for observation given by regulatory, customer & other corporate quality audits under guidance of HOD & co-ordination with concern department.
Prepare and review of standard operating procedure pertaining to QMS system and implement at site by imparting training.
The candidate should be from Pharma(OSD) Industry only.
The candidate should Have knowledge and Exposure of GDP/ GMP.
The candidate should have good communication skills (Verbal & Written)
The candidate should have Regulatory exposure(USFDA).
The Candidate should have team under him in current assignment.
Interested candidate, Please share the resumes at my mail id [email protected]