Require GM / DGM - Quality Assurance in Albany Molecular Research Inc. (AMRI)

For more than 20 years, as Albany Molecular Research Inc. (AMRI), we have provided fully integrated drug discovery, development and manufacturing services – all while adapting to the rapidly changing needs of our customers within the pharmaceutical, biotechnology and related industries.
With locations in the United States, Europe and Asia, AMRI SMARTSOURCING™ offers you a versatile and strategic way of partnering with us that is designed to deliver reduced risk, greater flexibility and a better return on investment. AMRI has successfully partnered R&D programs and is actively seeking to out-license its remaining programs for further development.

Post: GM / DGM - Quality Assurance

The project manager role is responsible for the overall coordination and execution of projects.
Job Responsibilities:

To assist the Management in executing all GMP / GLP related activities.
Timely reply to customer queries.
To monitor and prepare budgetary provisions for procuring new QA equipment, upgrade the facility and smooth working of the department.
To co-ordinate with Head of manufacturing, Stores, Production and maintenance to document any change control requirement for any changes carried out. 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 review and approve completed batch production and laboratory control records of critical process steps before release of the finished products for distribution.
To approve all specifications, STPs, SOPs and master production instructions.
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, External calibration certificates review.
Responsible for releasing or rejecting all API’s, Releasing or rejecting saleable intermediates.
To appraise the management of any new regulatory requirement and to take appropriate action to implement such changes.
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.
To make sure that there is a stability data to support retest or expiry dates and storage conditions on final product and or intermediates where appropriate.
QA Head will face the Regulatory audits / inspections, GMP deficiencies quality related complaints, and will coordinate and inform to higher management regarding audit observations / queries and after discussing with management finalized copy shall be forwarded to respective regulatory agencies.

Candidate Profile:

Bachelor/Master degree in science.
Minimum of 7 years industry experience in a cGMP environment. Devices are a plus.
Knowledgeable in FDA cGMPs (21 CFR, 211, 820, and /or other 600); ISO 9001 and 13485 a plus.

Must be skilled in the use of computers, software and spreadsheets. Must have strong organizational skills and ability to prioritize, schedule and multi-task. Must have a minimum of 3 years supervisory/management and/or project management experience in a pharmaceutical company.

Additional Information:
Experience: 7 years
Qualification: M.Sc, M.Pharm
Location: Aurangabad
Industry Type: Pharma/Biotech
Functional Area: QA
Last Date: 15^th July, 2016