Position: Manager/Asst. Manager - QA

Location: Silvassa

Experience: 8 - 10 YEARS

Industries: Pharma Formulation

Responsibilities:

To monitor and prepare budgetary provisions for procuring new QA equipment, upgrade the facility and smooth working of the department.
To release or reject all raw materials, intermediates, packing materials, labeling materials and finished products.
Site Master File Updation, Validation Master Plan Updation, Quality Manual Updation.
Handling of Market Complaints, Returns /Recall, Deviations, OOS, Validation report review.
Vendor on site audits, Handling and Managing of audits to meet AMRI ILS requirement.
Performing on site audits of vendors as per the requirements given by other AMRI global sites.
To approve completed batch production and laboratory control records of critical process steps before release of the finished products for distribution.
To review and approve all specifications, STPs, SOPs, BMR, BCR, MFR.
To review and approve all procedures impacting the quality of raw materials, intermediates or APIs.
To review and approve of all validation protocols and reports.
To ensure quality related complaints are investigated and resolved in coordination with QC, QA, and production departments.
To handle critical quality systems like deviations, change control, CAPA, training, OOS, validations and Qualifications.
To review and approve annual product quality reviews.
Involvement in investigations and closure of CAPA..
Responsible for releasing or rejecting all API- s, Releasing or rejecting saleable intermediates.
To review and approve changes that potentially impact intermediate or final product quality.
To carryout self-inspection (internal audits) of the facility to ensure GMP systems are being adhered to.
To coordinate with the regulatory and customers auditors for timely completion of auditing, compliance reports etc.
To review and approve of contract laboratories, critical starting materials vendors, intermediate or APIs contract manufacturers and Quality Agreements Management.
Preparing and implementing quality assurance policies and procedures.
Performing routine inspections and quality tests.
Identifying and resolving workflow and production issues.
Ensuring that standards and safety regulations are observed.
Addressing and discussing issues and proposed solutions with superiors.
Documenting quality assurance activities and creating audit reports.
Making recommendations for improvement.
Creating training materials and operating manuals.

Required Skills

Logical thinking.
Organizing.
Good in communication.

Required Qualification: - B.Sc/M.Sc - Chemistry/B.Pharm/M.Pharm

Salary :- Upto 12.00 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-

QA,Quality Assurance,Pharmacy,IPQA

Designation: Manager/Asst. Manager - QA

Vacancies: 1

Experience: 8.0 Year(s) - 10.0 Year(s)