Zydus Pharmaceuticals – Urgent Requirement for IPQA / QMS – OSD Manufacturing Facility

Zydus Pharmaceuticals (The Zydus Group) with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 23000 people worldwide and is driven by its mission to unlock new possibilities in life-sciences through quality healthcare solutions that impact lives. The group aspires to become a global life-sciences company transforming lives through pathbreaking discoveries. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.

Greetings from Zydus Pharmaceuticals!!!!

We are looking for IPQA Lead for our OSD Manufacturing Facility based out of Ahmedabad.

Education Qualification: M.Pharmacy/ B. Pharmacy
Experience : 18-20 Years of experience in IPQA .

Roles and Responsibilities:

Working as IPQA lead and leading team of QA professionals having exposure to Line clearance, In Process, Sampling of In process and finished products, Swab sampling and Review of BMR for manufacturing and Packing line in Oral Solid Dosage Manufacturing facilities.
Directing the In-process controls during product manufacturing and packaging Authorizing various documentation including batch documents, Validation & Qualification documents, Hold time, scale up and Technology transfer documentation.
Reviewing the systems, cGMP compliance and their improvement Preparing & reporting the monthly quality report.
Extensive experience in In-process Quality Assurance as a team Leader of IPQA Team for implementation of compliance in Manufacturing area as per cGMP.
To review of all GMP related documents (SOP,PROTOCAL and Reports ).
Reviewing BMR,BPR and compilation of documents for batch release.
Handling of Audit Trail review and periodic audit trail review.
In process monitoring of manufacturing activities of Tablet, Capsule.
Document review of quality and manufacturing as APQR,SOP, Validation Protocol, Hold time Protocol and reports, manufacturing investigation report, and all other GMP related document.
Handling of internal audit .
Investigation to find out the root cause for any non conformance.
Verify the process validation sample as per process validation protocol.
Handling all area as per regulatory compliance.

Candidate details:

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 be Handling the team of IPQA professionals in his current role.

Interested candidate, Please share the resumes at my mail id [email protected].

Regards

Team HR

ZPL- SEZ-II

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 .

Roles and Responsibilities:

The candidate should be handling of Process investigation, Market complaint, Adverse drug events, incidents, CAPA & Change Controls in Track wise 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.