Job Description
Hello,
We have urgent opening as Sr. Officer or Executive QA, at. Khopoli.
Organization is into Manufacturing of Healthcare products from decades.
Qualification :-B. Sc., M. Sc. B. Pharm, M.Pharm.
Experience :- 3 - 5 Years is Similar Role an Organization
Industry Background :- Manufacturing
Main Duties & Functions :-
- Vendor qualification: - Preparation of Planner for Conducting of vendor Audits, follow up, collect, review and compilation of Vendor documents. Like Technical agreements, Questionnaires, certification and accreditations.
- To Set up the Process quality checks at every level of process and audit system.
- Responsible for Review and timely submission of various documents (MFR, BMR, BPR, Validation reports, Deviation, Manufacturing process etc.) for regulatory filling.
- Preparing, and monitoring the implementation of documents APQR, Quality Manual, Validation Master Plan, Protocols for process validation, cleaning validation etc.).
5. Ensuring that specifications and test procedures for raw materials, packing materials, in-process testing, stability testing etc. are all in place.
6. Reviewing training records to check if on-the-job and induction training is taking place according to the schedule and whether QC (Quality Control) analysts are being validated.
7. Ensuring that planned/unplanned changes or deviations or incidents are documented, reviewed and analyzed, and recommending studies, tests or validation activities to be performed.
8. Logging and responding to customer complaints, supervising the investigation into the cause of the issue, providing an investigation report to the customer, etc.
9. Initiating, documenting and investigating market returns, reprocessing or destruction (for finished batches) and informing regulatory authorities about defects found after distribution.
10. Training of subordinates.
11. Reviewing and approving manufacturing records and QC testing data before any intermediate, finished batch is released, as well as periodic trending of this data.
12. Initiating an OOS (out of specification) investigation and reviewing the QC test if any raw material, packaging, intermediate or stability sample does not meet established and approved specification during the latter.
If you comfortable with JOB Description please revert with following details:
1) Your Current CTC -
2) Expected CTC -
3) Notice Period -
4) Total Years of Experience -
5) No of years in current Organization-
6) Current Residence -
7) Comfortable with Khopoli - (Yes/NO)
8) Highest Qualification -
9) Reason for Job Change
10) Any Health Issues Current or Previous - (Yes/NO)
11) Updated CV along with Photograph -
Thanks & Regards,
Vijay Shinde
RG HR SOLUTIONS
Navi Mumbai - 410 208
Recruitment I Compliance Management I Staffing I Training & Development
Contact - 9833315*** / 9373815***
Email -r************1@gm**l.com
Employement Category:
Employement Type: Full time
Industry: Manufacturing
Role Category: Quality (QA-QC)
Functional Area: Not Applicable
Role/Responsibilies: Urgent opening as Sr. Officer or Executive QA
Contact Details:
Company: RG HR Solutions
Location(s): Mumbai