Manager, Quality Assurance, ExM

Job Description

Key Responsibilities

Overall Objective

To ensure that Quality Assurance Systems as per Schedule M and World Health Organization (WHO) Good Manufacturing Practices (GMP) guidelines are established implemented & adhered to across the organization.

Key Responsibilities

A. Customer complaint management

1. Back up DPOC (Designated Point of Contact) for PQC (Product quality Complaint).

2. Complaint register in PV works system.

3. Acknowledge the complaint to complainant.

4. Communication with CMO for investigation and follow up.

5. Maintain Complaint Tracker.

6. Preparation of Investigation report and communication to commercial team.

7. Store all documents as per PV Audit requirement.

8. Handling of global PV Audit.

B. FPP batch release to market (both Domestic and imported products)

1. Review of COA and FPTA of all batches.

2. Storage of Documents specified folder

3. Release the batches in SAP system and communicate to warehouse for

further dispatch.

4. Updation of Product status in SAP on regular basis.

5. Expiry goods blocking in SAP

6. Sales returns goods update in SAP

7. Verification of expiry goods before destruction.

C. Change control (CC) management

1. Site trainer Change management Provides training to new employees on training.

2. Change initiator and change manager role.

3. Tracking of CC and other related tasks and follow up with stakeholders to

4. To ensure closure of CC and update in Reliance system.

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D. Artwork development management for local products

1. Review and approval of artwork for domestic market.

2. Coordination with CMO for implementation of new artwork.

3. Approval of shade card of printing matter before commercial batch.

Key Responsibilities

A. Document management

1. Ensure Data integrity in all the documentation process.

2. Preparation of SOP STP Specification of finished goods.

3. Preparation of MFR of companys products.

4. Share documents with CMO for further implementation.

5. To ensure implementation of these documents by CMO.

6. Maintain Stability Data Tracker

7. Follow up with CMO for updated stability data.

8. Store all products stability data in common folder.

9. Maintain separate folder for storage of documents in softcopy and update regularly. Ensure easy retrievability.

10. Organize to send documents to Document archival facility Writers on regular basis when required.

B. Management of Contract packaging operation:

Overprinting/Stickering/stamping of CMO Products.

1. Preparation of draft agreement.

2. Repacking product Indent approval

3. Review and Verification of Repacking products.

• Repacking products BPR approval.

C. Regular visit to CMOs to review the quality status and to resolve any issues.

1. Visit to CMO site for Verification of audit observation and review of documents to resolve any quality related issues and pending work.

2. Participate in Monthly meeting with all CMOs.

D. Verification and approval of waste / expired damaged goods.

disposal at CMO.

1. Quarterly visit to central warehouse Bhiwandi.

2. Verification of documents related waste expired damaged goods at

central warehouse before sending to central waste management center

Taloja Mumbai.

3. Verification of vehicle for intactness and sealing after loading the material.

E. Preparation of draft Quality agreement

1. Preparation of draft quality agreement for CMOs and warehouses.

2. Co-ordination with supplier to get it signed.

3. Regular update in AFFACTs (global archival system).

F. Supplier audit:

1. Quality audit of supplier like CMOs primary and printed packing material supplier facility on regular interval.

2. Preparation of audit report.

3. Follow up with supplier for the effective closure of observation.

4. Update the details in Reliance system.

G. Support to other stakeholders like GSM PTS Commercial and RA:

1. Provide required documents to Regulatory department for product

registration purpose. ( e.g. COA Stability Data Specification STP)

2. Provide COA Stability Data for Institutional business purpose.

3. Provide Stability data COA for export business purpose.

4. Organise regular meeting within Quality team with other stakeholder whenever required and CMOs on regular basis and share minutes of meeting.

5. Support to GSM and PTS for project related activity during tech transfer activity and new product development and qualification / validation activity.

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Person Specifications:

Essential / Desired

Education

Bachelors / Masters degree in science / Pharmacy

Knowledge on Pharma Quality system.

Experience

6-8 years relevant experience in the pharmaceutical production unit.

3-5 years direct supervision and quality assurance experience.

Min 5 years experience work experience in Quality assurance department dealing with all QMS modules.

Critical Competencies

CommunicationSkills

Working knowledge of computer

software viz. MS Office and SAP system.

Knowledge on ISO GMP and GLP systems.

Knowledge on validation / qualification systems viz. DQ IQ OQ & PQ.

Quality auditing skills

Editing skills for documentation viz. MFR BMR SOP.

Fully understand the inter-related elements that comprise quality system documentation control and training programs.

Role Specific

Perseverance

Decision Quality

Behavioral

Problem Solving

Informing

Integrity and Trust

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

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